AP ( DrugBank: - )
4 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 2 | 筋萎縮性側索硬化症 | 84 |
| 6 | パーキンソン病 | 308 |
| 13 | 多発性硬化症／視神経脊髄炎 | 295 |
| 299 | 嚢胞性線維症 | 130 |
2. 筋萎縮性側索硬化症
臨床試験数 : 645 / 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05286372 (ClinicalTrials.gov) | September 23, 2022 | 9/3/2022 | An Intermediate Size Expanded Access Protocol of AMX0035 for ALS | An Intermediate Size, Expanded Access Protocol to Provide AMX0035, a Fixed Combination of Sodium Phenylbutyrate (PB) and Taurursodiol (TURSO), for the Treatment of Adult Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: AMX0035 | Amylyx Pharmaceuticals Inc. | NULL | Approved for marketing | 18 Years | N/A | All | United States;Puerto Rico | ||
| 2 | NCT05237284 (ClinicalTrials.gov) | April 13, 2022 | 2/2/2022 | Phase 2 Study for SAR443820 in Participants With Amyotrophic Lateral Sclerosis (ALS) | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SAR443820 in Adult Participants With Amyotrophic Lateral Sclerosis, Followed by an Open-label Extension | Amyotrophic Lateral Sclerosis | Drug: SAR443820;Drug: Placebo | Sanofi | NULL | Recruiting | 18 Years | 80 Years | All | 261 | Phase 2 | United States;Belgium;Canada;China;France;Germany;Italy;Japan;Netherlands;Spain;Sweden;United Kingdom |
| 3 | NCT04820478 (ClinicalTrials.gov) | April 1, 2022 | 24/3/2021 | Efficacy and Tolerability of Beta Hydroxybutyrate Ester in Patients With Amyotrophic Lateral Sclerosis (ALS) | Efficacy and Tolerability of Beta Hydroxybutyrate Ester in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Dietary Supplement: Beta Hydroxybutyrate Ester;Dietary Supplement: Placebo | University of Ulm | NULL | Recruiting | 18 Years | N/A | All | 76 | N/A | Germany |
| 4 | JPRN-jRCT2071210117 | 23/02/2022 | 21/01/2022 | Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS | A Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in subjects with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | - Oral edaravone administered once daily for up to 48 weeks or until the drug is commercially available in that country - Oral edaravone administered for 10 days followed by 18-day placebo (regimen denoted as on/off) for up to 48 weeks or until the drug is commercially available in that country | Kondo Kazuoki | NULL | Recruiting | >= 18age old | Not applicable | Both | 300 | Phase 3 | US;Canada;Germany;Italia;South Korea;Switzerland;Japan |
| 5 | EUCTR2019-001862-13-PT (EUCTR) | 18/02/2022 | 21/05/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Greece;Spain;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 6 | EUCTR2020-005971-11-DE (EUCTR) | 22/12/2021 | 11/06/2021 | A Phase 2a study to evaluate, safety, tolerability, pharmacodynamic markers, and pharmacokinetics of AP-101 in patients with amyotrophic lateral sclerosis (ALS) | A Phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, pharmacodynamic markers, and pharmacokinetics of AP-101 in patients with familial amyotrophic lateral sclerosis (fALS) and sporadic amyotrophic lateral sclerosis (sALS) | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: AP-101 Product Code: AP-101 INN or Proposed INN: Not yet available Other descriptive name: Anti-(misfolded human superoxide dismutase 1) human IgG1m3 monoclonal antibody | AL-S Pharma, AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 63 | Phase 2 | United States;Canada;Germany;Sweden;Korea, Republic of | ||
| 7 | NCT05039268 (ClinicalTrials.gov) | November 25, 2021 | 23/8/2021 | 3K3A-APC for Treatment of Amyotrophic Lateral Sclerosis (ALS) | A Phase 2 Open Label Trial of 3K3A-APC in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: 3K3A-APC Protein | Macquarie University, Australia | ZZ Biotech, LLC | Completed | 18 Years | 75 Years | All | 16 | Phase 2 | Australia |
| 8 | EUCTR2019-001862-13-DK (EUCTR) | 21/09/2021 | 30/06/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Sweden | ||
| 9 | EUCTR2019-003797-10-NL (EUCTR) | 23/07/2021 | 09/11/2020 | A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALS | A Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: PEGCETACOPLAN | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 228 | Phase 2 | United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Belgium;Poland;Australia;Netherlands;Germany;Japan | ||
| 10 | EUCTR2019-003797-10-CZ (EUCTR) | 13/05/2021 | 27/10/2020 | A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALS | A Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: PEGCETACOPLAN | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 228 | Phase 2 | United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Belgium;Poland;Australia;Germany;Netherlands;Japan | ||
| 11 | NCT03843710 (ClinicalTrials.gov) | April 30, 2021 | 14/2/2019 | 31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Amyotrophic Lateral Sclerosis (REPAIR-ALS) | A Phase 2, Pilot Open Label, Sequential Group, Investigator Blinded Study of Magnetic Resonance Spectroscopy (31P-MRS) to Assess the Effects of CNM-Au8 for the Bioenergetic Improvement of Impaired Neuronal Redox State in Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Gold Nanocrystals | Clene Nanomedicine | University of Texas Southwestern Medical Center | Not yet recruiting | 35 Years | 75 Years | All | 24 | Phase 2 | United States |
| 12 | EUCTR2019-003797-10-IE (EUCTR) | 06/04/2021 | 03/09/2020 | A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALS | A Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aspaveli Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: PEGCETACOPLAN | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 228 | Phase 2 | United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Brazil;Poland;Australia;Netherlands;Germany;Japan | ||
| 13 | EUCTR2019-003797-10-DE (EUCTR) | 18/02/2021 | 12/10/2020 | A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALS | A Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aspaveli Product Name: Pegcetacoplan Product Code: APL-2 INN or Proposed INN: PEGCETACOPLAN | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 228 | Phase 2 | United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 14 | EUCTR2019-003797-10-IT (EUCTR) | 03/02/2021 | 28/07/2021 | A Study to Evaluate the Safety and Efficacy of Pegcetacoplan in Subjects with ALS | A Phase 2, randomized, double-blind, placebo-controlled, multicenter studyto evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) - MERIDIAN | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pegcetacoplam Product Code: [APL-2] Other descriptive name: N/A | APELLIS PHARMACEUTCIALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 228 | Phase 2 | United States;Czechia;Spain;Ukraine;Ireland;United Kingdom;Italy;France;Czech Republic;Argentina;Brazil;Belgium;Poland;Australia;Germany;Netherlands;Japan | ||
| 15 | EUCTR2019-001862-13-NO (EUCTR) | 03/02/2021 | 20/11/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | Portugal;United States;Slovenia;Spain;Ukraine;Ireland;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 16 | EUCTR2019-001862-13-IT (EUCTR) | 03/02/2021 | 06/11/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - non applicable | Patients suffering from Amyotrophic Lateral Sclerosis (ALS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib mesilate Product Code: [AB1010] INN or Proposed INN: Masitinib mesilate Other descriptive name: 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-thiazolyl]amino]phenyl]-benzamide, methane sulphonic acid salt. AB1010base; AB 1003 Product Name: Masitinib mesilate Product Code: [AB1010] INN or Proposed INN: Masitinib mesilate Other descriptive name: 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-thiazolyl]amino]phenyl]-benzamide, methane sulphonic acid salt. AB1010base; AB 1003 | AB SCIENCE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 17 | JPRN-jRCT2041200084 | 23/12/2020 | 24/12/2020 | Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS) | A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Oral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free period | Kondo Kazuoki | NULL | Not Recruiting | >= 18age old | Not applicable | Both | 140 | Phase 3 | United States of America;Canada;Germany;France;Italy;Japan |
| 18 | EUCTR2019-001862-13-PL (EUCTR) | 01/12/2020 | 09/07/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 19 | EUCTR2019-001862-13-SE (EUCTR) | 14/10/2020 | 23/03/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | Portugal;United States;Slovenia;Spain;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 20 | NCT04579666 (ClinicalTrials.gov) | September 30, 2020 | 22/9/2020 | MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis;Motor Neuron Disease | Drug: Pegcetacoplan (APL-2);Other: Placebo | Apellis Pharmaceuticals, Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 249 | Phase 2 | United States;Australia;Belgium;Czechia;France;Germany;Ireland;Italy;Japan;Netherlands;Poland;Spain;Ukraine;United Kingdom |
| 21 | EUCTR2019-001862-13-ES (EUCTR) | 15/09/2020 | 12/06/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ireland;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 22 | NCT04288856 (ClinicalTrials.gov) | April 28, 2020 | 26/2/2020 | Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults C9ORF72-Associated Amyotrophic Lateral Sclerosis (ALS) | An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults With C9ORF72-Associated Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: BIIB078 | Biogen | NULL | Terminated | 18 Years | N/A | All | 75 | Phase 1 | United States;Canada;Netherlands;Switzerland;United Kingdom |
| 23 | NCT04326283 (ClinicalTrials.gov) | April 2, 2020 | 24/3/2020 | Trial of Safety, Tolerability and Efficacy of Trametinib (SNR1611) in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Sequential Dose-Escalation, Randomized, Active-Controlled, Multi-Center, Phase 1/2a Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of SNR1611 in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Trametinib (0.5 mg);Drug: Trametinib (1 mg);Drug: Riluzole (100 mg) | Genuv Inc. | NULL | Recruiting | 19 Years | 75 Years | All | 30 | Phase 1/Phase 2 | Korea, Republic of |
| 24 | EUCTR2019-001862-13-SI (EUCTR) | 12/03/2020 | 19/02/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 25 | NCT04220021 (ClinicalTrials.gov) | January 10, 2020 | 3/1/2020 | Safety and Therapeutic Potential of the FDA-approved Drug Metformin for C9orf72 ALS/FTD | A Single-Center, Open Label Study to Assess the Safety and Tolerability of Metformin in Subjects With C9orf72 Amyotrophic Lateral Sclerosis Over 24 Weeks of Treatment | C9orf72 Amyotrophic Lateral Sclerosis (ALS);Frontotemporal Dementia | Drug: Metformin | University of Florida | NULL | Recruiting | 18 Years | 80 Years | All | 18 | Phase 2 | United States |
| 26 | NCT03981536 (ClinicalTrials.gov) | October 10, 2019 | 30/5/2019 | A Study to Evaluate AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS) | A Multicenter, Open Label, Single-Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: AP-101 | AL-S Pharma | NULL | Active, not recruiting | 18 Years | N/A | All | 18 | Phase 1 | Canada |
| 27 | ChiCTR1900024520 | 2019-07-22 | 2019-07-13 | Split-hand index calculated by F-wave test apply to the diagnosis of amyotrophic lateral sclerosis | Split-hand index calculated by F-wave test apply to the diagnosis of amyotrophic lateral sclerosis | Amyotrophic lateral sclerosis | Gold Standard:Clinical outcome meet the Awaji-Shima Criteria 2008;Index test:Split-hand index calculated by F-wave test; | Peking Union Medical College Hospita | NULL | Recruiting | 18 | 80 | Both | Target condition:300;Difficult condition:50 | N/A | China |
| 28 | EUCTR2019-000374-39-IT (EUCTR) | 15/07/2019 | 27/01/2021 | Extension study of Arimoclomol in patients with amyotrophic lateral sclerosis. | Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial - na | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arimoclomol Product Code: [BRX-345] INN or Proposed INN: ARIMOCLOMOL | ORPHAZYME APS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 231 | Phase 3 | United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 29 | NCT04176224 (ClinicalTrials.gov) | April 17, 2019 | 22/11/2019 | Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis | Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS) | Japanese Patients With ALS | Drug: MT-1186 | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 20 Years | 75 Years | All | 9 | Phase 1 | Japan |
| 30 | NCT03693781 (ClinicalTrials.gov) | April 10, 2019 | 30/9/2018 | Colchicine for Amyotrophic Lateral Sclerosis | Colchicine for Amyotrophic Lateral Sclerosis: a Phase II, Randomized, Double Blind, Placebo Controlled, Multicenter Clinical Trial | Amyotrophic Lateral Sclerosis | Drug: Colchicine 1 MG Oral Tablet;Drug: Placebo Oral Tablet | Azienda Ospedaliero-Universitaria di Modena | University of Modena and Reggio Emilia;University of Turin, Italy;Istituto Auxologico Italiano;IRCCS National Neurological Institute C. Mondino Foundation;University of Bari;IRCCS San Raffaele;University of Padova;University of Milan;Istituto Di Ricerche Farmacologiche Mario Negri;University of Campania Luigi Vanvitelli;Catholic University of the Sacred Heart | Completed | 18 Years | 80 Years | All | 54 | Phase 2 | Italy |
| 31 | NCT02437110 (ClinicalTrials.gov) | April 1, 2019 | 5/5/2015 | HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS) | HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Darunavir;Drug: Ritonavir;Drug: Dolutegravir;Drug: Tenofovir alafenamide (TAF) | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Active, not recruiting | 18 Years | N/A | All | 122 | Phase 1 | United States |
| 32 | JPRN-JMA-IIA00419 | 29/03/2019 | 29/03/2019 | Phase 1 dose-escalation study of bosutinib in patients with amyotrophic lateral sclerosis (ALS) | Phase 1 dose-escalation study of bosutinib in patients with amyotrophic lateral sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Intervention type:DRUG. Intervention1:Medicine, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:The study consists of a 12-week observation period, a 1-week (5- to 9-day) transitional period, a 12-week study treatment period, and a 4-week follow-up period. . | Center for iPS Cell Research and Application (CiRA), Kyoto University | NULL | Recruiting | >=20 YEARS | <80 YEARS | BOTH | 24 | Phase 1 | Japan |
| 33 | JPRN-UMIN000036295 | 2019/03/29 | 26/03/2019 | Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) | Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) - Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | The study consists of a 12-week observation period, a 1-week (5- to 9-day) transitional period, a 12-week study treatment period, and a 4-week follow-up period. 3 to 6 ALS patients will be enrolled in each of the 4 bosutinib dose levels [100 mg/day (dose level 1), 200 mg/day (dose level 2), 300 mg/day (dose level 3), or 400mg/day (dose level 4)] to evaluate the safety and tolerability of the investigational drug (bosutinib) under a 3+3 dose escalation study design. | Center for iPS Cell Research and Application, Kyoto University | Provider of the investigational product: Pfizer Japan Inc. | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 24 | Phase 1 | Japan |
| 34 | EUCTR2018-000137-13-IT (EUCTR) | 08/10/2018 | 22/01/2021 | A study to compare the use of Arimoclomol with placebo in patients withAmyotrophic Lateral Sclerosis | A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis - na | Amyotrophic Lateral Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Arimoclomol Product Code: [BRX-345] INN or Proposed INN: ARIMOCLOMOL | ORPHAZYME APS | NULL | Not Recruiting | Female: yes Male: yes | 231 | Phase 3 | France;United States;Canada;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 35 | NCT03482050 (ClinicalTrials.gov) | April 12, 2018 | 14/3/2018 | A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Phase I/IIa, Open Label, Dose-escalating Clinical Study to Evaluate the Safety, Tolerability and Theraputic Effects of Transplantation of Astrocytes Derived From Human Embryonic Stem Cells (hESC), in Patients With Amyotrophic Lateral Sclerosis (ALS) | ALS (Amyotrophic Lateral Sclerosis) | Biological: AstroRx | Kadimastem | NULL | Completed | 18 Years | 70 Years | All | 16 | Phase 1/Phase 2 | Israel |
| 36 | NCT03334786 (ClinicalTrials.gov) | April 5, 2018 | 26/10/2017 | Study to Evaluate Safety & Efficacy of FLX-787-ODT to Treat Fasciculations in Tongue and Appendicular Muscle in Adult Subjects With ALS | An Open Label Study to Evaluate the Safety and Efficacy of FLX-787-ODT for Treatment of Fasciculations in the Tongue and One Appendicular Muscle in Adult Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis;Fasciculation | Drug: FLX-787-ODT | Flex Pharma, Inc. | NULL | Terminated | 18 Years | N/A | All | 3 | Phase 1/Phase 2 | United States |
| 37 | NCT03679975 (ClinicalTrials.gov) | April 4, 2018 | 19/9/2018 | Riluzole Oral Soluble Film (ROSF) Swallowing Safety in Amyotrophic Lateral Sclerosis (ALS) | A Single Center Study to Evaluate the Effect of Riluzole Oral Soluble Film on Swallowing Safety in Individuals With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: Riluzole Oral Soluble film (ROSF) 50 mg | Aquestive Therapeutics | inVentiv Health Clinical;Covance | Terminated | 18 Years | 80 Years | All | 9 | Phase 2 | United States |
| 38 | JPRN-UMIN000029308 | 2017/07/18 | 30/09/2018 | Study on efficacy and safety as well as on the changes in blood purine compounds by the treatment of patients with amyotrophic lateral sclerosis with febuxostat and inosine in combination. | Study on efficacy and safety as well as on the changes in blood purine compounds by the treatment of patients with amyotrophic lateral sclerosis with febuxostat and inosine in combination. - Effect of febuxostat and inosine on amyotrophic lateral sclerosis | Amyotrophic lateral sclerosis | Febuxostat 20 mg, Inosine 500 mg, twice a day for 14 days | Teikyo University | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 3 | Not applicable | Japan |
| 39 | JPRN-jRCTs031180173 | 07/07/2017 | 01/03/2019 | Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis | Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis | amyotrophic lateral sclerosis amyotrophic lateral sclerosis;G122 | gradual increase of lacosamide from 100mg to 400mg for 4 weeks | Kuwabara Satoshi | NULL | Complete | >= 20age old | Not applicable | Both | 30 | Phase 1-2 | Japan |
| 40 | JPRN-UMIN000027476 | 2017/06/01 | 01/06/2017 | Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis | Open-label clinical trial: safety of lacosamide in patients with amyotrophic lateral sclerosis - Open-label clinical trial of lacosamide in ALS | amyotrophic lateral sclerosis | gradual increase of lacosamide from 100mg to 400mg for 4 weeks | Department of Neurology Chiba University Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 41 | NCT03103815 (ClinicalTrials.gov) | April 24, 2017 | 1/4/2017 | Trial of Amivita in Amyotrophic Lateral Sclerosis | Trial of Amivita in Amyotrophic Lateral Sclerosis: a Single-center, Single-blind, Self-controlled Clinical Trial | Amyotrophic Lateral Sclerosis | Drug: Amivita | Wujin People's Hospital | Nanjing 1718 Biotech Co. Ltd | Recruiting | 18 Years | 70 Years | All | 30 | N/A | China |
| 42 | NCT03019419 (ClinicalTrials.gov) | April 24, 2017 | 10/1/2017 | Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS) | Perampanel for Sporadic Amyotrophic Lateral Sclerosis (ALS): A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trials | ALS | Drug: Perampanel;Drug: placebo | Tokyo Medical University | NULL | Completed | 40 Years | 78 Years | All | 66 | Phase 2 | Japan |
| 43 | NCT03049046 (ClinicalTrials.gov) | April 7, 2017 | 3/2/2017 | CC100: Phase 1 Multiple-Dose Safety and Tolerability in Subjects With ALS | Protocol CC100B. CC100: Phase 1 Multiple-Dose Safety and Tolerability in Subjects With ALS | Amyotrophic Lateral Sclerosis | Drug: CC100;Drug: Placebos | Chemigen, LLC | NULL | Recruiting | 18 Years | 64 Years | All | 21 | Phase 1 | United States |
| 44 | NCT02943850 (ClinicalTrials.gov) | April 1, 2017 | 20/10/2016 | CNS10-NPC-GDNF for the Treatment of ALS | Human Neural Progenitor Cells Secreting Glial Cell Line-Derived Neurotrophic Factor (CNS10-NPC-GDNF) for the Treatment of Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Biological: Stem cell (HPC) implantation;Device: Stereotactic surgical device | Cedars-Sinai Medical Center | California Institute for Regenerative Medicine (CIRM) | Completed | 18 Years | N/A | All | 18 | Phase 1 | United States |
| 45 | JPRN-UMIN000026221 | 2017/03/02 | 01/03/2017 | Safety of perampanel in patients with motor neuron disease | Safety of perampanel in patients with motor neuron disease - Safety of perampanel in patients with motor neuron disease | amyotrophic lateral sclerosis | Once daily perampanel with dose escalation from 2mg to 8mg. | Department of Neurology, Juntendo University School of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 15 | Phase 1 | Japan |
| 46 | JPRN-UMIN000024854 | 2016/11/16 | 16/11/2016 | Clinical study of the effectiveness of edaravone for the oxidative stress in amyotrophic lateral sclerosis | Clinical study of the effectiveness of edaravone for the oxidative stress in amyotrophic lateral sclerosis - Clinical study for the anti-oxidative stress by edaravone in ALS | Amyotrophic Lateral Sclerosis (ALS) | Edaravone treatment for ALS patients | Okayama university | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 20 | Not applicable | Japan |
| 47 | NCT03241784 (ClinicalTrials.gov) | May 16, 2016 | 27/7/2017 | T-Regulatory Cells in Amyotrophic Lateral Sclerosis | Expansion and Infusion of T-Regulatory Cells in Amyotrophic Lateral Sclerosis | ALS (Amyotrophic Lateral Sclerosis) | Biological: Autologous T-regulatory lymphocytes;Biological: Interleukin-2 | Stanley H. Appel, MD | NULL | Unknown status | 18 Years | N/A | All | 4 | Phase 1 | United States |
| 48 | NCT02709330 (ClinicalTrials.gov) | April 2016 | 5/3/2016 | ALS Reversals - Lunasin Regimen | An Open-label, Single-center, 12-month Trial of a Lunasin Regimen for Patients With Amyotrophic Lateral Sclerosis (ALS) | ALS (Amyotrophic Lateral Sclerosis) | Drug: Lunasin Regimen;Other: Historical control | Richard Bedlack, M.D., Ph.D. | NULL | Completed | 18 Years | N/A | All | 60 | Phase 2 | United States |
| 49 | JPRN-UMIN000019111 | 2015/10/01 | 01/10/2015 | CaHMB L-arginine-glutamine blended drinks (Abound (TM)) for amyotrophic lateral sclerosis patients and sarcopenia improvement effect by drinking. | CaHMB L-arginine-glutamine blended drinks (Abound (TM)) for amyotrophic lateral sclerosis patients and sarcopenia improvement effect by drinking. - The sarcopenia improvement effect by Abound (TM) drinking against ALS | Amyotrophic lateral sclerosis | Abound(TM) 1,Take one pack twice a day in the moring and evening 2,Drinking was dissolved in water 240 ~ 300ml 3,Before meals, after meals does not matter 4,12 weeks | National Hospital Organization Takasaki General Medical Center | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 20 | Not selected | Japan |
| 50 | EUCTR2010-024423-24-NL (EUCTR) | 21/09/2015 | 09/09/2015 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 19.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2;Phase 3 | Portugal;United States;Serbia;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany | ||
| 51 | NCT02987413 (ClinicalTrials.gov) | April 28, 2015 | 1/7/2016 | Escalated Application of Mesenchymal Stem Cells in Amyotrophic Lateral Sclerosis Patients | Safety and Efficacy of Mesenchymal Stem Cells Escalated Application in Amyotrophic Lateral Sclerosis Patients: Study Design of a Phase I Trial | Motor Neuron Disease | Biological: Autologous Mesenchymal stem cells (MSCs) | Hospital e Maternidade Dr. Christóvão da Gama | IEP São Lucas - Instituto de Ensino e Pesquisa;Clinica Jordy Sinapse;TECHLIFE - Centro de Tecnologia Celular | Completed | 18 Years | N/A | All | 3 | Phase 1 | Brazil |
| 52 | EUCTR2010-024423-24-HU (EUCTR) | 21/04/2015 | 31/10/2014 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 17.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ireland;Israel;Colombia;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Germany;Netherlands | ||
| 53 | EUCTR2010-024423-24-PT (EUCTR) | 10/04/2015 | 03/11/2014 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 381 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany | ||
| 54 | NCT02463825 (ClinicalTrials.gov) | April 2015 | 21/4/2015 | A Registry-Based Clinical Trial of Pimozide in Patients With Neuromuscular Junction Transmission Dysfunction Due to ALS | A Registry-Based Randomized-Controlled, Double-Blinded Clinical Trial of Pimozide in Patients With Neuromuscular Junction Transmission Dysfunction Due to Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis (ALS) | Drug: Pimozide 2 mg per day;Drug: Pimozide 4 mg per day;Drug: Placebo (Lactose tablet) | University of Calgary | Hotchkiss Brain Institute, University of Calgary | Active, not recruiting | 18 Years | N/A | Both | 25 | Phase 2 | Canada |
| 55 | EUCTR2010-024423-24-GR (EUCTR) | 06/03/2015 | 21/11/2013 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | Patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 17.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 381 | Phase 2;Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Argentina;Netherlands;Germany | ||
| 56 | JPRN-UMIN000016352 | 2015/02/01 | 01/02/2015 | The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis: Single centered open label trial | The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis: Single centered open label trial - The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis | amyotrophic lateral sclerosis | edaravone | Ehime University Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 10 | Phase 1,2 | Japan |
| 57 | EUCTR2012-002099-15-SE (EUCTR) | 15/09/2014 | 01/08/2014 | Safety and Efficacy of Apovir for treatment of patients with ALS (Amyotrophic lateral sclerosis) | A randomised, double blind, placebo controlled trial to evaluate the safety and efficacy of Apovir for treatment of patients with Amyotrophic lateral sclerosis | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 17.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Pleconaril Product Code: APO-P001 INN or Proposed INN: PLECONARIL Trade Name: Copegus Product Name: Ribavirin Other descriptive name: RIBAVIRIN | Apodemus AB | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Sweden | |||
| 58 | EUCTR2010-024423-24-SK (EUCTR) | 07/04/2014 | 05/12/2013 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 381 | Phase 2;Phase 3 | Portugal;United States;Serbia;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany | ||
| 59 | NCT02166944 (ClinicalTrials.gov) | April 2014 | 9/6/2014 | Tamoxifen Treatment in Patients With Motor Neuron Disease | The Study of Tamoxifen Treatment in Patients With Motor Neuron Disease | Amyotrophic Lateral Sclerosis;ALS Functional Ration Scale;TAR-DNA-binding Protein-43;Tamoxifen;mTOR | Drug: tamoxifen 40 mg daily for one year | Taipei Medical University Shuang Ho Hospital | NULL | Completed | 20 Years | 80 Years | All | 20 | Phase 1/Phase 2 | Taiwan |
| 60 | JPRN-UMIN000011494 | 2013/09/02 | 02/09/2013 | Assessment of the efficacy and the influence on swallowing function of transdermal scopolamine for ALS patinets' drooling | Assessment of the efficacy and the influence on swallowing function of transdermal scopolamine for ALS patinets' drooling - SCOPOLA-D | amyotrophic lateral sclerosis | scopolamine patch 7days-washout 7days-placebo patch 7days placebo patch 7days-washout 7days-scopolamine patch 7days | Mie University Graduate school of medicine,Department of neurology | Matsusaka Chuou HospitalNational Mie Hospital | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 10 | Not applicable | Japan |
| 61 | NCT02164253 (ClinicalTrials.gov) | September 2013 | 20/5/2014 | Focal Accumulation of Iron in Cerebral Regions in Early ALS (Amyotrophic Lateral Sclerosis) Patients | Feasibility and Safety Pilot Therapeutic Study of the Iron Chelator Deferiprone in Amyotrophic Lateral Sclerosis | ALS (Amyotrophic Lateral Sclerosis);Iron Overload | Drug: Deferiprone | University Hospital, Lille | ApoPharma | Completed | 18 Years | 85 Years | All | 23 | Phase 2 | France |
| 62 | NCT02588677 (ClinicalTrials.gov) | April 2013 | 20/10/2015 | Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS) | Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of Masitinib | Amyotrophic Lateral Sclerosis (ALS) | Drug: Masitinib (4.5);Drug: Riluzole;Drug: Placebo;Drug: Masitinib (3.0) | AB Science | NULL | Completed | 18 Years | N/A | All | 394 | Phase 2/Phase 3 | Spain |
| 63 | NCT01806857 (ClinicalTrials.gov) | April 2013 | 5/3/2013 | Clinical Trial Nuedexta in Subjects With ALS | The Experimental Treatment of Bulbar Dysfunction in Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Drug: Nuedexta;Drug: Matching Placebo | Center for Neurologic Study, La Jolla, California, | ALS Association;State University of New York - Upstate Medical University | Completed | 18 Years | N/A | All | 90 | Phase 2 | United States |
| 64 | EUCTR2010-024423-24-ES (EUCTR) | 29/01/2013 | 29/11/2012 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel group, phase 2 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: MASITINIB | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Portugal;France;Hungary;Slovakia;Greece;Spain;Ireland;Netherlands;Italy | ||
| 65 | JPRN-UMIN000006423 | 2011/10/01 | 01/10/2011 | The clinical trial to assess efficacy of mexiletine for amyotrophic lateral sclerosis | The clinical trial to assess efficacy of mexiletine for amyotrophic lateral sclerosis - Mexiletine on amyotrophic lateral sclerosis | amyotrophic lateral sclerosis | administration of mexiletine and riluzole administration of riluzole only | Department of Neurology, Graduate School of Medicine, Chiba University, Japan. | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 60 | Not selected | Japan |
| 66 | NCT00876772 (ClinicalTrials.gov) | March 2011 | 6/4/2009 | Olanzapine for the Treatment of Appetite Loss in Amyotrophic Lateral Sclerosis (ALS) | Randomized, Placebo-controlled Parallel Group Study for the Evaluation of an Oral Dose of 10mg Olanzapine in Combination With Riluzole for the Treatment of Loss of Appetite in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Drug: Olanzapine | Charite University, Berlin, Germany | NULL | Recruiting | 18 Years | 80 Years | Both | 40 | Phase 2/Phase 3 | Germany |
| 67 | NCT02880033 (ClinicalTrials.gov) | February 2011 | 3/8/2016 | Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes | Modulation of Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes of Patients With Parkinson's Disease or Amyotrophic Lateral Sclerosis | Parkinson's Disease;Amyotrophic Lateral Sclerosis;Oxidative Stress;Iron Overload | Drug: deferiprone;Drug: placebo | University Hospital, Lille | NULL | Completed | 18 Years | 80 Years | All | 90 | N/A | France |
| 68 | EUCTR2008-003982-21-FR (EUCTR) | 10/06/2010 | 14/01/2010 | Etude des transporteurs de la dopamine et de la sérotonine en imagerie TEMP utilisant les radiopharmaceutiques 123I-FP-CIT (datscan) and 123 I-ADAM dans la sclérose latérale amyotrophique et dans une population contrôle. DOSERALS - DOSERALS | Etude des transporteurs de la dopamine et de la sérotonine en imagerie TEMP utilisant les radiopharmaceutiques 123I-FP-CIT (datscan) and 123 I-ADAM dans la sclérose latérale amyotrophique et dans une population contrôle. DOSERALS - DOSERALS | Patients présentant une SLA et volontaires sains MedDRA version: 8.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Trade Name: DaTSCAN Product Name: Datscan INN or Proposed INN: Ioflupane 123I Product Name: [I-123] ADAM INN or Proposed INN: [I-123] ADAM | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Not Recruiting | Female: yes Male: yes | France | ||||
| 69 | EUCTR2008-007320-25-ES (EUCTR) | 10/08/2009 | 16/07/2009 | Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzoleEstudio fase II/III, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, para valorar la seguridad y eficacia de TRO 19622 en pacientes con Esclerosis Lateral Amiotrófica (ELA) tratados con riluzol. | Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzoleEstudio fase II/III, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo, para valorar la seguridad y eficacia de TRO 19622 en pacientes con Esclerosis Lateral Amiotrófica (ELA) tratados con riluzol. | ESCLEROSIS LATERAL AMIOTRÓFICA.ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles due to destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease. MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Name: TRO19622 Product Code: TRO19622 INN or Proposed INN: olesoxime Other descriptive name: 4-cholesten-3-one, oxime | TROPHOS SA | NULL | Not Recruiting | Female: yes Male: yes | 470 | Phase 2 | France;Belgium;Spain;Germany;United Kingdom | ||
| 70 | JPRN-UMIN000002276 | 2009/08/01 | 01/08/2009 | Developmental research of communication devices based on the brain machine interface using electroencephalograms | Developmental research of communication devices based on the brain machine interface using electroencephalograms - Communication devices using EEG-based BMI | amyotrophic lateral sclerosis | Let the patients use the communication devices to select characters on a computer monitor as they intend by recording EEG. | Osaka University | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 10 | Not applicable | Japan |
| 71 | EUCTR2008-007320-25-DE (EUCTR) | 24/06/2009 | 18/02/2009 | Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole | Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole | ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles because of destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug therapy that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease. MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Code: TRO19622 INN or Proposed INN: olesoxime Other descriptive name: 4-cholesten-3-one, oxime | TROPHOS SA | NULL | Not Recruiting | Female: yes Male: yes | 470 | Phase 2/3 | United Kingdom;Germany;Belgium;France;Spain | ||
| 72 | EUCTR2008-007320-25-BE (EUCTR) | 08/06/2009 | 28/04/2009 | Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole | Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole | ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles because of destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug therapy that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease. MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Code: TRO19622 INN or Proposed INN: olesoxime Other descriptive name: 4-cholesten-3-one, oxime | TROPHOS SA | NULL | Not Recruiting | Female: yes Male: yes | 470 | Phase 2;Phase 3 | France;Spain;Belgium;Germany;United Kingdom | ||
| 73 | NCT00868166 (ClinicalTrials.gov) | April 30, 2009 | 23/3/2009 | Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALS | Phase II/III, Multicenter, Randomized, Parallel Group, Double-blind, Placebo Controlled Study to Assess Safety and Efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With Riluzole | Amyotrophic Lateral Sclerosis | Drug: Olesoxime;Drug: Placebo Comparator;Drug: Riluzole | Hoffmann-La Roche | European Commission | Completed | 18 Years | 80 Years | All | 512 | Phase 3 | Belgium;France;Germany;Spain;United Kingdom;Netherlands |
| 74 | NCT00886977 (ClinicalTrials.gov) | April 2009 | 21/4/2009 | Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS) | Pilot-Study of YAM80 in Amyotrophic Lateral Sclerosis. Evaluation of the Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: YAM80 | Yoshino Neurology Clinic | NULL | Active, not recruiting | 25 Years | 65 Years | Both | 25 | Phase 2 | Japan |
| 75 | EUCTR2008-006891-31-GB (EUCTR) | 17/02/2009 | 28/07/2010 | A randomised placebo-controlled trial of Lithium carbonate in Amyotrophic Lateral Sclerosis (LiCALS) - LiCALS | A randomised placebo-controlled trial of Lithium carbonate in Amyotrophic Lateral Sclerosis (LiCALS) - LiCALS | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Trade Name: Lithium Apogepha Product Name: Lithium Carbonate Other descriptive name: LITHIUM CARBONATE Trade Name: Lithium Carbonate Product Name: Lithium Carbonate Other descriptive name: LITHIUM CARBONATE Trade Name: Lithium Citrate Product Name: Lithium Citrate Other descriptive name: LITHIUM CITRATE | King's College London | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 4 | United Kingdom | ||
| 76 | EUCTR2008-007320-25-FR (EUCTR) | 17/02/2009 | 16/03/2009 | Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole | Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole | ALS is a fatal neuromuscular disorder causing progressive loss of nervous control of voluntary muscles because of destruction of motor neurons in the brain and spinal cord.Riluzole is the only approved drug therapy that has been shown to prolong survival of ALS patients but its efficacy is limited.Consequently, there is a strong medical need to identify other compounds and to evaluate in clinical studies their potential to become a treatment of this devastating disease. MedDRA version: 9.1;Level: LLT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Product Code: TRO19622 INN or Proposed INN: olesoxime Other descriptive name: 4-cholesten-3-one, oxime | TROPHOS SA | NULL | Not Recruiting | Female: yes Male: yes | 470 | Phase 2;Phase 3 | France;Spain;Belgium;Germany;United Kingdom | ||
| 77 | EUCTR2007-003775-39-DE (EUCTR) | 29/10/2008 | 09/09/2008 | Randomised, placebo-controlled parallel-group trial to evaluate an oral dose of 10 mg Olanzapin combined with Riluzol for the treatment of appetite loss on patients with amyotrophic lateral sklerosis - Olanzapin in treatment of ALS-related appetite loss | Randomised, placebo-controlled parallel-group trial to evaluate an oral dose of 10 mg Olanzapin combined with Riluzol for the treatment of appetite loss on patients with amyotrophic lateral sklerosis - Olanzapin in treatment of ALS-related appetite loss | patients with amyotrophic lateral sclerosis | Trade Name: Zyprexa INN or Proposed INN: OLANZAPINE | Charité – Universitätsmedizin Berlin | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 78 | EUCTR2008-003707-32-FR (EUCTR) | 09/10/2008 | 22/08/2008 | Etude de l'effet du carbonate de lithium sur une population de patients atteints de SLA en ouvert en comparaison avec une population de référence. LISLA - LISLA | Etude de l'effet du carbonate de lithium sur une population de patients atteints de SLA en ouvert en comparaison avec une population de référence. LISLA - LISLA | Patient atteint de sclérose latérale amyotrophique. MedDRA version: 8.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis | Trade Name: Téralithe LP Product Name: Téralithe LP INN or Proposed INN: Carbonate de lithium | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 79 | EUCTR2008-002110-22-NL (EUCTR) | 16/09/2008 | 05/08/2008 | A randomised sequential trial of Lithium in amyotrophic lateral sclerosis - Lithium in ALS | A randomised sequential trial of Lithium in amyotrophic lateral sclerosis - Lithium in ALS | Amyotrophic lateral sclerosis (ALS) is a disease characterised by progressive degeneration of motor neurons in brain and spinal cord leading to muscle weakness. ALS can occur at anytime in adulthood. Muscle weakness gradually progresses. Approximately 50% of patients die within 3 years after onset of symptoms, usually as the result of respiratory failure. To date, only one drug, i.e. riluzole, has proven to extend survival in patients with ALS, but only by approximately 3 to 6 months. MedDRA version: 9.1;Level: LLT;Classification code 10052889;Term: ALS | Trade Name: Lithiumcarbonaat 400 PCH tabletten Product Name: Lithiumcarbonaat Other descriptive name: LITHIUM CARBONATE | Prof. dr L.H. van den Berg, UMC-Utrecht | NULL | Not Recruiting | Female: yes Male: yes | Netherlands | ||||
| 80 | NCT00444613 (ClinicalTrials.gov) | April 2007 | 6/3/2007 | A Study in Patients With Amyotrophic Lateral Sclerosis (ALS) | A Phase II/III Study in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Drug: E0302 (mecobalamin);Drug: Placebo | Eisai Co., Ltd. | NULL | Completed | 20 Years | N/A | Both | 373 | Phase 2/Phase 3 | Japan |
| 81 | NCT00107770 (ClinicalTrials.gov) | April 2005 | 7/4/2005 | Safety Study of Oral Sodium Phenylbutyrate in Subjects With ALS (Amyotrophic Lateral Sclerosis) | Safety and Dose Escalating Study of Oral Sodium Phenylbutyrate in Subjects With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: sodium phenylbutyrate | Department of Veterans Affairs | Muscular Dystrophy Association | Completed | 18 Years | N/A | Both | 40 | Phase 1/Phase 2 | United States |
| 82 | NCT00243932 (ClinicalTrials.gov) | April 2005 | 24/10/2005 | Clinical Trial of High Dose CoQ10 in ALS | Clinical Trial of High Dose CoQ10 in ALS | Amyotrophic Lateral Sclerosis;Lou Gehrig's Disease | Drug: coenzyme Q10;Drug: Placebo | Columbia University | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 21 Years | 85 Years | All | 185 | Phase 2 | United States |
| 83 | NCT00136110 (ClinicalTrials.gov) | April 2005 | 24/8/2005 | Trial of Sodium Valproate in Amyotrophic Lateral Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Sequential Clinical Trial of Sodium Valproate in ALS | Amyotrophic Lateral Sclerosis | Drug: Sodium Valproate | UMC Utrecht | Princess Beatrix Fund, The Netherlands | Completed | 18 Years | 85 Years | Both | 165 | Phase 3 | Netherlands |
| 84 | NCT00812851 (ClinicalTrials.gov) | April 2005 | 21/11/2008 | Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS) | Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS) | Cramps;Amyotrophic Lateral Sclerosis | Drug: Dronabinol | Cantonal Hospital of St. Gallen | ALS Association | Completed | 18 Years | N/A | Both | 24 | N/A | Switzerland |
6. パーキンソン病
臨床試験数 : 2,307 / 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05669170 (ClinicalTrials.gov) | January 2024 | 16/12/2022 | Methylphenidate for Apathy in Veterans With Parkinson's Disease | Evaluating Safety and Potential Benefit of Methylphenidate as a Symptomatic Treatment for Apathy in Veterans With Parkinson's Disease. | Parkinson Disease;Apathy | Behavioral: Psychosocial intervention;Drug: Methylphenidate | Ralph H. Johnson VA Medical Center | NULL | Not yet recruiting | 40 Years | N/A | All | 60 | Phase 2 | NULL |
| 2 | NCT05709301 (ClinicalTrials.gov) | April 1, 2023 | 11/1/2023 | Randomized Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease | Multicenter, Randomized, Double-blinded, Placebo-controlled Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease | Parkinson Disease;Mild Cognitive Impairment | Drug: Donepezil Hydrochloride;Drug: Placebo | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | NULL | Not yet recruiting | 50 Years | 80 Years | All | 120 | Phase 2 | NULL |
| 3 | NCT05634876 (ClinicalTrials.gov) | April 2023 | 23/11/2022 | UB-312 in Patients With Synucleinopathies | A Phase 1b Clinical Trial of UB-312 in Patients With Synucleinopathies | Multiple System Atrophy;Parkinson Disease | Biological: UB-312 Injection;Biological: Placebo Injection | NYU Langone Health | NULL | Not yet recruiting | 40 Years | 75 Years | All | 8 | Phase 1/Phase 2 | United States |
| 4 | NCT05094011 (ClinicalTrials.gov) | March 1, 2023 | 20/7/2021 | Evaluating Safety, Tolerability, and Efficacy of Autologous MitoCell Transplantation in Subjects With Idiopathic Parkinson's Disease | A Phase I Open-Label Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of Autologous MitoCell (Adipose-Derived Mesenchymal Stem Cells) Transplantation in Subjects With Idiopathic Parkinson's Disease | Idiopathic Parkinson's Disease | Biological: Aadipose-Derived Mesenchymal Stem Cells | Taiwan Mitochondrion Applied Technology Co., Ltd. | NULL | Not yet recruiting | 45 Years | 70 Years | All | 9 | Phase 1 | NULL |
| 5 | JPRN-jRCTs041220054 | 15/08/2022 | 15/08/2022 | The effects of prebiotics on Parkinson's disease patients with wearing-off | The effects of prebiotics on wearing-off and intestinal environment in patients with Parkinson's disease | Parkinson's disease patients with wearing-off over 20 years old | administration of kestose and inulin Dose / Usage) Kestose: 6 g (3 g in the morning, 3 g in the evening) / 2 times a day, orally Inulin: 6g (3g in the morning, 3g in the evening) / 2 times a day, orally Administration period) 8 weeks | Hirooka Yoshiki | Watanabe Hirohisa | Recruiting | >= 20age old | Not applicable | Both | 20 | Phase 1-2 | Japan |
| 6 | NCT05696665 (ClinicalTrials.gov) | July 5, 2022 | 20/12/2022 | Role of Saffron and Chamomile in the Management of Parkinson's Disease | Role of Saffron and Chamomile and Their Active Compounds in the Management of Parkinson Disease in the Context of Psychometric and Biochemical Measures | Parkinson Disease;Neurodegenerative Diseases | Other: conventional therapy;Drug: Saffron and Chamomile;Drug: Crocin and Apigenin | Jinnah Postgraduate Medical Centre | Aga Khan University Hospital, Pakistan;Liaquat National Hospital & Medical College | Recruiting | 40 Years | 85 Years | All | 120 | N/A | Pakistan |
| 7 | JPRN-UMIN000047341 | 2022/07/01 | 31/03/2022 | Randomized controlled trial of the efficacy and feasibility of a mHealth-type dance program for people with Parkinson's disease. | Randomized controlled trial of the efficacy and feasibility of a mHealth-type dance program for people with Parkinson's disease. - Randomized controlled trial of the efficacy and feasibility of a mHealth-type dance program for people with Parkinson's disease. | Parkinson's disease | The dance exercise group will have one online lesson per week with a coach, 60 minutes (see Appendix for details) and 30 minutes of video dance (movement review and lesson) as a home trainer to perform the exercises. The active control group was instructed to perform stretching, flexibility, and relaxation exercises (excluding strength, balance, aerobic, and functional training) three times a week for 30 minutes per session. These exercises were selected from several physical therapy programs created for persons with Parkinson's disease. | Department of Neurology, Fukuoka university | NULL | Pending | 30years-old | 75years-old | Male and Female | 60 | Not selected | Japan |
| 8 | NCT05590637 (ClinicalTrials.gov) | April 22, 2022 | 18/10/2022 | Comparing Antipsychotic Medications in LBD Over Time | A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease | Parkinson's Disease Psychosis;Dementia With Lewy Bodies | Drug: Pimavanserin;Drug: Quetiapine | The University of Texas Health Science Center at San Antonio | Alzheimer's Association | Recruiting | N/A | N/A | All | 94 | Phase 4 | United States |
| 9 | NCT05348785 (ClinicalTrials.gov) | April 19, 2022 | 4/4/2022 | A Study to Assess the Safety of BIIB122 Tablets and if it Can Slow the Worsening of Early-Stage Parkinson's Disease in Participants Between the Ages of 30 and 80 | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants With Parkinson's Disease | Parkinson Disease | Drug: BIIB122;Drug: BIIB122-Matching Placebo | Biogen | Denali Therapeutics Inc. | Recruiting | 30 Years | 80 Years | All | 640 | Phase 2 | United States;France;Germany;Netherlands;Poland;Spain |
| 10 | NCT05312632 (ClinicalTrials.gov) | April 5, 2022 | 28/3/2022 | A Study to Evaluate the Efficacy and Safety of Safinamide Mesilate as Add-on Therapy to Levodopa in Parkinson's Disease Participants With Motor Fluctuation in South Korea | A Multi-center, Open-label Phase 4 Study Evaluating the Efficacy and Safety of Safinamide Mesilate as Add-on Therapy to Levodopa in Parkinson's Disease Patients With Motor Fluctuation in South Korea | Parkinson Disease | Drug: Safinamide Mesilate | Eisai Korea Inc. | NULL | Recruiting | 19 Years | N/A | All | 199 | Phase 4 | Korea, Republic of |
| 11 | JPRN-jRCTs052220012 | 01/04/2022 | 22/04/2022 | A study of the short-term gait improvement effect using a biological signal reaction type motor function improvement device in patients withParkinson's disease. | A study of the short-term gait improvement effect using a biological signal reaction type motor function improvement device for gait instability in patients with Parkinson's disease. a randomized controlled trial | Parkinson's disease Parkinson's disease | The normal rehabilitation group and the HAL grou p are assigned 1: 1 and the normal rehabilitation g roup is subjected to normal walking training, and t he HAL group is subjected to walking training by H AL. | Kohara Nobuo | NULL | Recruiting | >= 20age old | Not applicable | Both | 30 | N/A | Japan |
| 12 | NCT04879134 (ClinicalTrials.gov) | February 28, 2022 | 4/5/2021 | Apomorphine Effects on Pain in Parkinson's Disease | Apomorphine Effect on Pain in Parkinson's Disease: A Randomized, Double-blind Placebo Cross-over Study | Parkinson Disease | Drug: Apomorphine Injectable Solution;Drug: Placebo | University of Calgary | Paladin Labs Inc. | Recruiting | 18 Years | 70 Years | All | 40 | Phase 2/Phase 3 | Canada |
| 13 | NCT04887467 (ClinicalTrials.gov) | September 16, 2021 | 26/4/2021 | Monocentric, Prospective Study to Assess the Pharmacokinetic Profile of Continuous and Diurnal Subcutaneous Apomorphine Infusion in Patients With Parkinson's Disease | Pharmacokinetic Study of Continuous and Diurnal Subcutaneous Apomorphine Infusion in Patients With Parkinson's Disease Under Stabilized Treatment. | Parkinson Disease | Drug: Apomorphine | Rennes University Hospital | NULL | Recruiting | 50 Years | 70 Years | Male | 20 | Phase 4 | France |
| 14 | NCT04867642 (ClinicalTrials.gov) | April 29, 2021 | 27/4/2021 | A Study to Test the Safety, Tolerability, and Blood Levels of UCB0022 in Healthy Participants and Participants With Parkinson's Disease | A First-In-Human, Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled, Single- and Multiple-Dose, Dose-Escalating Study Evaluating the Safety, Tolerability, and Pharmacokinetics of UCB0022 in Healthy Participants and Participants With Parkinson's Disease | Healthy Study Participants;Parkinson's Disease | Drug: UCB0022;Other: Placebo | UCB Biopharma SRL | NULL | Active, not recruiting | 18 Years | 75 Years | All | 100 | Phase 1 | United Kingdom |
| 15 | NCT04377945 (ClinicalTrials.gov) | April 28, 2021 | 4/5/2020 | Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components | A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson's Disease Patients With Dyskinesia to Assess the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and Its Individual Components | Dyskinesias;Parkinson Disease | Drug: Part 1, JM-010 component Group A;Drug: Part 1, JM-010 component Group B;Drug: Part 1, JM-010 component Group C;Drug: Part 1, Placebo Group;Drug: Part 2, JM-010 combination Group A;Drug: Part 2, JM-010 combination Group B;Drug: Part 2, JM-010 component Group C;Drug: Part 2, Placebo Group | Bukwang Pharmaceutical | NULL | Recruiting | 18 Years | 85 Years | All | 188 | Phase 2 | United States |
| 16 | EUCTR2021-000826-89-FR (EUCTR) | 23/04/2021 | 25/03/2021 | Etude pharmacocinétique de l’apomorphine en perfusion sous-cutanée continue diurne chez le patient parkinsonien équilibré sous traitement | Etude pharmacocinétique de l’apomorphine en perfusion sous-cutanée continue diurne chez le patient parkinsonien équilibré sous traitement | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: APOKINON Product Name: APOKINON Product Code: N04BC07 | CHU Rennes | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 20 | Phase 4 | France | ||
| 17 | NCT04497168 (ClinicalTrials.gov) | April 1, 2021 | 29/7/2020 | Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease | Citalopram as a Posterior Cortical Protective Therapy in Parkinson Disease | Parkinson Disease | Drug: Citalopram 20mg;Drug: Placebo | University of Michigan | National Institute on Aging (NIA) | Recruiting | 65 Years | N/A | All | 58 | Phase 2 | United States |
| 18 | NCT04491383 (ClinicalTrials.gov) | April 1, 2021 | 22/7/2020 | Tocotrienols in Parkinson's Disease (PD) | Tocotrienols in Parkinson's Disease (PD): A Pilot, Randomised, Placebo-controlled Trial | Neuro-Degenerative Disease;Parkinson Disease | Drug: Tocovid Suprabio (HOV-12020);Other: Placebo | National Neuroscience Institute | Hovid Berhad | Recruiting | 40 Years | 90 Years | All | 100 | Phase 2 | Singapore |
| 19 | JPRN-jRCTs051200160 | 24/03/2021 | 24/03/2021 | ZEAL study | Zonisamide for the Efficacy of Sleep Abnormality in Parkinson's Disease: A Randomized Single-Blind Placebo-Controlled Trial - ZEAL | Parkinson's disease Parkinson's disease,Somnipathy;D010300 | 70 patients with Parkinson's disease were allocated to Zonisamide tablets (Trelief OD tablets) 1T (25mg) or placebo 1T at a time before going to bed by randomizing soft, and the efficacy of zonisamide tablet (Trelief OD tablets) for sleep is investigated comparing the parallel-group before and after administration | Hiroshi Kataoka | NULL | Recruiting | >= 41age old | Not applicable | Both | 70 | Phase 2-3 | Japan |
| 20 | JPRN-jRCTs031200172 | 23/12/2020 | 26/10/2020 | Effects of Elobixibat administration in patients with Parkinson's syndrome complicated with chronic constipation | Multicenter, Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Study Investigating the Efficacy and Safety of Elobixibat in Patients with Parkinson's Disease Complicating Chronic Constipation. - CONST-PD | Parkinson's disease, chronic constipation Parkinson's syndrome,chronic constipation,Symptomatic constipation | Take 10mg of Elobixibat or placebo once a day before meal. After the 2-week screening period, the study drug will be started on the day of enrollment. | Hatano Taku | Mochida Pharmaceutical Co., Ltd.;EA Pharma Co., Ltd. | Not Recruiting | >= 20age old | Not applicable | Both | 100 | N/A | Japan |
| 21 | NCT04685265 (ClinicalTrials.gov) | December 22, 2020 | 17/12/2020 | A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of anle138b in Parkinson's Disease | A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of anle138b, and to Characterise the Effect of Food of anle138b in Mild to Moderate Parkinson's Disease | Parkinson Disease | Drug: anle138b;Drug: Placebo | MODAG GmbH | Aptuit (Verona) Srl, an Evotec Company;Quotient Sciences;Nottingham University Hospitals NHS Trust | Active, not recruiting | 40 Years | 80 Years | All | 72 | Phase 1 | United Kingdom |
| 22 | ChiCTR2000039697 | 2020-11-15 | 2020-11-06 | Application of etomidate in deep brain stimulation under general anesthesia for Parkinson's disease | Application of etomidate in deep brain stimulation under general anesthesia for Parkinson's disease | Parkinson Disease | Experimental group:Etomidate-based anesthesia;Control group: Propofol-based anesthesia; | Department of Anesthesiology, the First Affiliated Hospital of Sun Yat-Sen University | NULL | Recruiting | 18 | 80 | Both | Experimental group:30;Control group:30; | Phase 4 | China |
| 23 | EUCTR2019-003315-60-NL (EUCTR) | 10/11/2020 | 08/10/2020 | A study investigating the effect and safety of a new potential drug for Parkinson's disease patients. | A phase 1/2 study investigating the pharmacokinetics, safety and efficacy of a highly concentrated buccal formulation of apomorphine (APORON®) in subjects with Parkinson's Disease - Buccal apomorphine (APORON) administration | Parkinson's Disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go Product Name: APO-go® INN or Proposed INN: Apomorphine Other descriptive name: APOMORPHINE HYDROCHLORIDE HEMIHYDRATE Product Name: APORON INN or Proposed INN: APORON Other descriptive name: APOMORPHINE HYDROCHLORIDE HEMIHYDRATE | Criceto IKM B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 46 | Phase 1;Phase 2 | Netherlands | ||
| 24 | ChiCTR2000037239 | 2020-10-01 | 2020-08-27 | Construction and application of a diagnostic marker for Parkinson's disease based on gut microbiomics | Construction and application of a diagnostic marker for Parkinson's disease based on gut microbiomics | Parkinson's disease | Gold Standard:All patients satisfied the United Kingdom Parkinson's Disease Society Brain Bank criteria;Index test:Microbial gene detection chip; | Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | NULL | Recruiting | 55 | 80 | Both | Target condition:500;Difficult condition:600 | China | |
| 25 | ChiCTR2000036006 | 2020-10-01 | 2020-08-21 | The applications of multi- MRI in early diagnosis of Parkinson's Disease based on deep learning | The applications of multi- MRI in early diagnosis of Parkinson's Disease based on deep learning | Parkinson's disease | Gold Standard:MDS clinical diagnostic criteria for Parkinson’s disease;Index test:multimodal MRI features in locus coeruleus and substantia nigra; | Zhongshan Hospital, Fudan University | NULL | Pending | 18 | 85 | Both | Target condition:400;Difficult condition:0 | China | |
| 26 | JPRN-UMIN000040889 | 2020/06/24 | 24/06/2020 | Comparison of gastrointestinal function before and after levodopa-carbidopa continuous infusion gel (LCIG) therapy for patients with Parkinson's disease | Comparison of gastrointestinal function before and after levodopa-carbidopa continuous infusion gel (LCIG) therapy for patients with Parkinson's disease - Comparison of gastrointestinal function before and after LCIG therapy for Parkinson's disease | Parkinson's disease | Levodopa-carbidopa continuous infusion gel (LCIG) therapy | Fujita Health University School of MedicineDepartment of Gastroenterology | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 200 | Phase 4 | Japan |
| 27 | NCT03959540 (ClinicalTrials.gov) | April 28, 2020 | 23/4/2019 | Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease | A Multinational, Multicentre, Prospective Non-interventional Study to Assess Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease | Parkinson Disease | Drug: Opicapone;Drug: Levodopa (L-DOPA) + Standard care | Bial - Portela C S.A. | NULL | Completed | 75 Years | N/A | All | 39 | United Kingdom | |
| 28 | NCT04768101 (ClinicalTrials.gov) | April 15, 2020 | 16/2/2021 | Quantitative Imaging of Brain Glymphatic Function in Humans | Quantitative Imaging of Brain Glymphatic Function in Humans | Parkinson Disease | Drug: [11C]-PIB | Vanderbilt University Medical Center | NULL | Recruiting | 55 Years | 80 Years | All | 140 | Early Phase 1 | United States |
| 29 | NCT04182399 (ClinicalTrials.gov) | April 1, 2020 | 24/11/2019 | Role of Zonisamide in Advanced Parkinson's Disease (PD) in Egyptian Population: Pilot Study | Role of Zonisamide in Advanced Parkinson's Disease (PD) in Egyptian Population: Pilot Study | Parkinson Disease | Drug: Zonisamide Capsules | Ain Shams University | NULL | Completed | 18 Years | N/A | All | 69 | N/A | Egypt |
| 30 | NCT04167540 (ClinicalTrials.gov) | April 1, 2020 | 7/11/2019 | GDNF Gene Therapy for Parkinson's Disease | Open-Label Safety Study of Glial Cell Line-Derived Neurotrophic Factor Gene Transfer (AAV2- GDNF) in Parkinson's Disease | Parkinson's Disease | Biological: AAV2-GDNF | Brain Neurotherapy Bio, Inc. | Asklepios Biopharmaceutical, Inc.;California Institute for Regenerative Medicine (CIRM) | Active, not recruiting | 35 Years | 75 Years | All | 11 | Phase 1 | United States |
| 31 | NCT02967250 (ClinicalTrials.gov) | April 1, 2020 | 13/9/2016 | Brain Bioenergetics in Parkinson's Disease and Response to Repeated Oral UDCA Treatment | 7T Magnetic Resonance Spectroscopy Monitoring Brain Bioenergetics in Parkinson's Disease and Response to Repeated Oral UDCA Treatment | Parkinson Disease | Drug: ursodeoxycholic acid | University of Minnesota | NULL | Not yet recruiting | 18 Years | N/A | All | 20 | Phase 1 | United States |
| 32 | ChiCTR1900027306 | 2019-11-15 | 2019-11-08 | Application of optical coherence tomography and detection of a-synuclein in tears in the diagnosis of Parkinson's disease | Morphological changes of retina in patients with Parkinson's disease and the role of a-synuclein in retinal damage | Parkinson's disease | Gold Standard:British brain bank Parkinson's disease diagnostic criteria;Index test:Application of optical coherence tomography to observe the retinal structure of the macular area, optic disc area and the expression level of a-synuclein in tears in the diagnosis of Parkinson's disease.; | The First Affiliated Hospital of Chengdu Medical College | NULL | Recruiting | Both | Target condition:85;Difficult condition:85 | China | |||
| 33 | NCT04148391 (ClinicalTrials.gov) | November 14, 2019 | 30/10/2019 | NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking) | A Study to Evaluate NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Associated With Parkinson's Disease or Prodromal or Manifest Lewy Body Dementia | Mild Cognitive Impairment;Mild Dementia;Parkinson Disease;Lewy Body Disease | Drug: Placebo Oral Capsule;Drug: NYX-458 | Aptinyx | CogState Ltd.;Worldwide Clinical Trials | Active, not recruiting | 50 Years | 80 Years | All | 99 | Phase 2 | United States |
| 34 | NCT04157933 (ClinicalTrials.gov) | October 16, 2019 | 1/11/2019 | Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's Disease | A Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Profile of AZ-009 in Subjects With Established Parkinson's Disease | Parkinson's Disease | Drug: 009-A1;Drug: 009-A2;Drug: 009-A3;Drug: 009-A0;Drug: 009-B1 (active --> placebo) crossover;Drug: 009-B2 (placebo --> active) crossover | Alexza Pharmaceuticals, Inc. | NULL | Completed | 30 Years | 85 Years | All | 35 | Phase 1 | Netherlands |
| 35 | JPRN-UMIN000037390 | 2019/07/01 | 16/07/2019 | An exploratory study to optimize the administration of COMT inhibitor on LCIG therapy | An exploratory study to optimize the administration of COMT inhibitor on LCIG therapy - Levodopa pharmacokinetics on concomitant use of LCIG therapy and COMT inhibitor | Parkinson's disease | Entacapone 100mg | Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine | Saiseikai Matsuyama Hospital | Pending | 20years-old | Not applicable | Male and Female | 10 | Not selected | Japan |
| 36 | JPRN-UMIN000036952 | 2019/06/04 | 04/06/2019 | A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients. | A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients. - A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients. | Patients who are suspected Parkinson's disease or related disorders, including dementia with Lewy bodies, multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, frontotemporal lobe degeneration, vascular parkinsonism, drug-induced parkinsonism, normal pressure hydrocephalus, and others. | 18F-FDOPA, 11C-Raclopride PET | Nagoya City Rehabilitation Agency | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 150 | Not applicable | Japan |
| 37 | JPRN-UMIN000036908 | 2019/05/31 | 31/05/2019 | A dementia study by 11C-PiB, 18F-FDG PET | A dementia study by 11C-PiB, 18F-FDG PET - A dementia study by 11C-PiB, 18F-FDG PET | mild cognitive impairment, Alzheimer's disease, dementia with Lewy bodies, cerebrovascular dementia, frontotemporal degeneration, progressive supranuclear palsy, corticobasal degeneration, Parkinson's disease with dementia, other neurodegenerative diseases, normal pressure hydrocephalus, hypoxic encephalopathy, brain tumor, brain injury etc. | 11C-PiB, 18F-FDG PET | Nagoya City Rehabilitation Agency | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 150 | Not applicable | Japan |
| 38 | NCT03693872 (ClinicalTrials.gov) | May 15, 2019 | 1/10/2018 | Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals | Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals | Parkinson Disease | Drug: Apomorphine;Drug: Dopaminergic Agonist + Apomorphine | Rennes University Hospital | NULL | Recruiting | 18 Years | N/A | All | 42 | N/A | France |
| 39 | NCT03781167 (ClinicalTrials.gov) | April 29, 2019 | 18/12/2018 | A Study to Evaluate the Safety and Tolerability of ABBV-951 in Participants With Parkinson's Disease (PD) | A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease | Parkinson's Disease (PD) | Drug: ABBV-951 | AbbVie | NULL | Completed | 30 Years | N/A | All | 244 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;Germany;Italy;Japan;Netherlands;Russian Federation;Spain;Sweden;United Kingdom;France |
| 40 | NCT03899324 (ClinicalTrials.gov) | April 26, 2019 | 29/3/2019 | Evaluation of the Efficacy and Safety of Bumetanide in Parkinson's Disease | A Randomized Double-blind Placebo-controlled Multicenter Proof-of-concept Trial to Assess the Efficacy and Safety of Bumetanide in Parkinson's Disease | Parkinson Disease | Drug: Bumetanide white, oblong, scored tablet;Drug: Placebo white, oblong, scored tablet | B&A Therapeutics | NULL | Recruiting | 40 Years | 80 Years | All | 40 | Phase 2 | France |
| 41 | JPRN-JapicCTI-194763 | 22/4/2019 | 20/05/2019 | Safety and PK study of LY03003 | An open-label study in Japanese patients with Parkinson's disease to evaluate the safety, pharmacokinetics and preliminary efficacy of LY03003 following intramuscular injections and its comparative bioavailability to Rotigotine transdermal patch. | Parkinson's Disease | Intervention name : Rotigotine INN of the intervention : Rotigotine Dosage And administration of the intervention : LY03003 IM injections 14, 28 and 56 mg/week. Control intervention name : Rotigotine INN of the control intervention : Rotigotine Dosage And administration of the control intervention : Rotigotine transdermal patch applications 4.5, 9 and 18 mg/day. | Shandong Luye Pharmaceutical Co., Ltd./CMIC Co., Ltd. | NULL | complete | 20 | BOTH | 32 | Phase 1 | Japan | |
| 42 | JPRN-jRCTs051180214 | 12/04/2019 | 27/03/2019 | The usefulness of flutemetamol for diagnostic imaging of neurogenerative disease | The usefulness of brain amyloid image using flutemetamol and glucose metabolism for the neurogenerative disease - The usefulness of brain amyloid image using flutemetamol and glucose metabolism for the neurogenerative disease | Alzheimer's disease,Dementia with Lewy Bodies,Parkinson's syndrome,Frontotemporal lober degeneration Alzheimer's disease, Dementia with Lewy Bodies, Parkinson's syndrome, Frontotemporal lober degeneration, Parkinson's disease, Mild cognitive impairment, Non-Alzheimer's disease, Progressive aphasia, Neurodegenerative disease, Cerebral corticobasal degeneration, Progressive supranuclear palsy | Amyloid PET: Given the flutemetamol (3mL) intravenously FDG-PET:Given the FDG scanR (3mL) intravenously | Itoh Yoshiaki | NULL | Recruiting | >= 20age old | Not applicable | Both | 100 | N/A | Japan |
| 43 | NCT03661125 (ClinicalTrials.gov) | April 11, 2019 | 4/9/2018 | SRC Inhibition as a Potential Target for Parkinson's Disease Psychosis | A Randomised, Balanced, Double-blind Two-way Crossover Design Study to Evaluate the Effects of SRC Kinase Inhibitor, Saracatinib, on Brain Activity Associated With Visual Processing in Patients With Parkinson's Disease Psychosis. | Parkinson Disease Psychosis | Drug: Saracatinib;Drug: Placebo Oral Tablet | King's College London | AstraZeneca;King's College Hospital NHS Trust | Recruiting | 40 Years | N/A | All | 30 | Early Phase 1 | United Kingdom |
| 44 | NCT03841604 (ClinicalTrials.gov) | April 9, 2019 | 30/1/2019 | Effect of Safinamide on Parkinson's Disease Related Chronic Pain | A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide 100mg Once Daily, as add-on Therapy, in Idiopathic Parkinson's Disease (PD) Patients With Motor Fluctuations and PD Related Chronic Pain | Idiopathic Parkinson Disease | Drug: Safinamide Methanesulfonate;Drug: Safinamide methanesulfonate matching placebo | Zambon SpA | NULL | Completed | 30 Years | N/A | All | 71 | Phase 4 | Austria;France;Germany;Italy;Spain |
| 45 | NCT03877510 (ClinicalTrials.gov) | April 3, 2019 | 12/3/2019 | Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in PD Patients With Motor Fluctuations | An Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor Fluctuations | Parkinson Disease | Drug: IPX203 140 mg;Drug: IPX203 210 mg;Drug: IPX203 280 mg;Drug: IPX203 350 mg | Impax Laboratories, LLC | NULL | Completed | 40 Years | N/A | All | 420 | Phase 3 | United States;Czechia;France;Germany;Italy;Poland;Spain;United Kingdom |
| 46 | ChiCTR1900026156 | 2019-04-01 | 2019-09-24 | Research for Parkinson's disease/Parkinson's disease dementia cohort and basic transformation | Research for Parkinson's disease/Parkinson's disease dementia cohort and basic transformation | Parkinson's disease | Parkinson's disease:NO;Parkinson's disease with chronic appendicitis-like lesions:NO;Parkinson's disease without chronic appendicitis-like lesions:NO; | The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) | NULL | Recruiting | Both | Parkinson's disease:100;Parkinson's disease with chronic appendicitis-like lesions:53;Parkinson's disease without chronic appendicitis-like lesions:47; | N/A | China | ||
| 47 | NCT03858270 (ClinicalTrials.gov) | April 1, 2019 | 2/10/2018 | Inhibition of a-synuclein Cell-cell Transmission by NMDAR Blocker, Memantine | Inhibition of a-synuclein Cell-cell Transmission by NMDAR Blocker, Memantine | Parkinson Disease | Drug: Memantine;Other: Placebo | Wayne State University | NULL | Recruiting | 45 Years | 85 Years | All | 50 | Phase 3 | United States |
| 48 | EUCTR2017-005170-19-FI (EUCTR) | 06/03/2019 | 07/12/2018 | A Long-Term Follow-up Safety Study for Patients with Parkinson’s Disease (PD) Implanted with the Drug Delivery System (DDS) and/or Who Received Treatment in the Main Study and/or Extension Study | A Long-Term Follow-up Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Implanted with the DDS and/or Who Received Treatment in the Main Study and/or Extension Study - Long-Term Follow-up Safety After DDS Implantation with/without CDNF Infusions | Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cerebral Dopamine Neurotrophic Factor Product Code: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor | Renishaw Neuro Solutions Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 1;Phase 2 | Finland;Sweden | ||
| 49 | NCT03391882 (ClinicalTrials.gov) | December 19, 2018 | 2/1/2018 | A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) | An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations | Motor OFF Episodes Associated With Parkinson's Disease | Drug: APL-130277;Drug: subcutaneous apomorphine | Sunovion | NULL | Completed | 18 Years | N/A | All | 113 | Phase 3 | Austria;France;Germany;Italy;Spain;United Kingdom |
| 50 | NCT03822364 (ClinicalTrials.gov) | November 26, 2018 | 18/12/2018 | Staccato Apomorphine Single and Multi Dose PK | A Randomized Study of the Safety, Tolerability, and Pharmacokinetics of AZ-009 (Staccato Apomorphine) in Healthy Volunteers and the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZ-009 in Subjects With Parkinson's Disease | Parkinson Disease | Drug: 009-1;Drug: active comparator;Drug: 009-0;Drug: 009-2;Drug: 009-3;Drug: 009-4;Drug: 009-5 | Alexza Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 60 Years | All | 56 | Phase 1 | Netherlands |
| 51 | EUCTR2018-000346-19-FI (EUCTR) | 03/10/2018 | 09/07/2018 | An extended clinical study to test the safety of Cerebral Dopamine Neurotrophic Factor (CDNF) by brain infusion via Drug Delivery System (DDS) in patients with Parkinson's disease. | A Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002. - Extension Study | Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cerebral Dopamine Neurotrophic Factor Product Code: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor | Herantis Pharma Plc | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 1;Phase 2 | Finland;Sweden | ||
| 52 | ChiCTR1800017084 | 2018-08-01 | 2018-07-11 | Investigation of new approaches and technologies in the management of Parkinson's disease | The efficacy of Butylphthalide on cognitive impairment of patients with idiopathic PD and DBS patients: A Randomized, double-blind, placebo-controlled, multicenter trial | Parkinson's disease | Butylphthalide group:Butylphthalide, 2 capsules/time, 3 times/day, for 48 weeks;Control group:Placebo, 2 capsules/time, 3 times/day, for 48 weeks; | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | NULL | Recruiting | 18 | 80 | Both | Butylphthalide group:140;Control group:140; | Phase 4 | China |
| 53 | JPRN-UMIN000033285 | 2018/08/01 | 05/07/2018 | The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease: multicenter/ non-blind/ randomised/ exploratory clinical trial | The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease: multicenter/ non-blind/ randomised/ exploratory clinical trial - The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease | Parkinson's disease | Oral bisphosphonate agent group: taking orally Minodronic Acid Hydrate (50mg) 1 tablet per 4 weeks Intravenous bisphosphonate agent group: injecting Zoledronic Acid (5mg) 1 ampule per 48 weeks | Department of Orthopaedic Surgery, Niigata University Medical and Dental Hospital | Department of Neurology, Nishi-Niigata Chuo Hospital | Pending | 50years-old | Not applicable | Male and Female | 100 | Not selected | Japan |
| 54 | EUCTR2017-005170-19-SE (EUCTR) | 30/07/2018 | 10/04/2018 | A Long-Term Follow-up Safety Study for Patients with Parkinson’s Disease (PD) Implanted with the Drug Delivery System (DDS) and/or Who Received Treatment in the Main Study and/or Extension Study | A Long-Term Follow-up Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Implanted with the DDS and/or Who Received Treatment in the Main Study and/or Extension Study - Long-Term Follow-up Safety After DDS Implantation with/without CDNF Infusions | Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cerebral Dopamine Neurotrophic Factor Product Code: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor | Renishaw Neuro Solutions Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 1;Phase 2 | Finland;Sweden | ||
| 55 | JPRN-UMIN000033409 | 2018/07/30 | 17/07/2018 | Prevention of local skin reaction by heparinoid due to rotigotine transdermal patch: a pilot randomized clinical trial. | Prevention of local skin reaction by heparinoid due to rotigotine transdermal patch: a pilot randomized clinical trial. - SkinHeRo | Parkinson's disease | Pretreatment by heparinoid In the pretreatment group, heparinoid is applied daily to the sites (shoulder, upper arm, abdomen, thigh, buttocks on both sides) to be applied rotigotine transdermal patch from the beginning of 1 week before. The dose is one finger tip unit (about 0.5 g) for two palms. The period is 8 weeks. Non-pretreatment by heparinoid. The non-pretreatment group use rotigotine without using heparinoid. The period is 8 weeks. | Wakayama Medical University | NULL | Complete: follow-up complete | 20years-old | 85years-old | Male and Female | 20 | Phase 1 | Japan |
| 56 | EUCTR2018-000346-19-SE (EUCTR) | 04/06/2018 | 09/04/2018 | An extended clinical study to test the safety of Cerebral Dopamine Neurotrophic Factor (CDNF) by brain infusion via Drug Delivery System (DDS) in patients with Parkinson's disease. | A Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002. - Extension Study | Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cerebral Dopamine Neurotrophic Factor Product Code: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor | Herantis Pharma Plc | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 1;Phase 2 | Finland;Sweden | ||
| 57 | EUCTR2016-003456-70-IT (EUCTR) | 04/05/2018 | 02/02/2021 | A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson¿s Disease patients | An Open-Label Randomized Crossover Trial, utilizing a Single-Blinded Rater to evaluate APL- 130277 compared to S.C. Apomorphine in Levodopa Responsive Subjects with Parkinson¿s Disease Complicated by Motor Fluctuations - A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson¿s Di | Levodopa Responsive Patients with Parkinson¿s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: APOMORPHINE HYDROCHLORIDE Trade Name: APO-go Product Name: s.c. apomorphine Product Code: n/a INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 | SUNOVION PHARMACEUTICALS INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 106 | Phase 3 | France;Spain;Austria;Germany;United Kingdom;Italy | ||
| 58 | NCT03374917 (ClinicalTrials.gov) | April 18, 2018 | 8/12/2017 | A Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 in an Outpatient Environment | An Open-Label Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 for up to 4 Weeks in an Outpatient Environment | Parkinson's Disease (PD) | Drug: ABBV-951 | AbbVie | NULL | Completed | 30 Years | 85 Years | All | 20 | Phase 1 | United States |
| 59 | NCT03230526 (ClinicalTrials.gov) | April 16, 2018 | 18/7/2017 | Identification of a Biomarker Predictive of Evolution of Parkinson Disease | Brain Microglial Activation in the Early Stage of the Parkinson's Disease: a Predictive Biomarker of the Evolution? | Parkinson Disease | Drug: [18F]DPA-714 PET scan | Nantes University Hospital | NULL | Recruiting | 40 Years | 67 Years | All | 64 | Phase 2 | France |
| 60 | NCT03368170 (ClinicalTrials.gov) | April 12, 2018 | 5/12/2017 | Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia | A Randomized, Placebo-controlled, Phase IIa Study Evaluating the Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia | Parkinson Disease | Drug: Mesdopetam (IRL790) | Integrative Research Laboratories AB | The Clinical Trial Company | Completed | 18 Years | 79 Years | All | 75 | Phase 2 | Sweden;United Kingdom |
| 61 | EUCTR2016-003456-70-DE (EUCTR) | 04/04/2018 | 03/04/2017 | A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patients | An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations | Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Trade Name: APO-go Product Name: s.c. apomorphine INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomor | Sunovion Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 106 | Phase 3 | France;Spain;Austria;Germany;United Kingdom;Italy | ||
| 62 | EUCTR2016-000637-43-IT (EUCTR) | 05/03/2018 | 21/01/2021 | Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson's Disease. | An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patientswith Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes). - Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson's Disease. | Levodopa Responsive Patients with Parkinson's Disease complicated by Motor Fluctuations (OFF Episodes) MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: [APL-130277] INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: Apomorphine hydrochloride Product Name: Apomorfina cloridrato Product Code: [APL-130277] INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: Apomorphine hydrochloride Product Name: Apomorfina cloridrato Product Code: [APL-130277] INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: Apomorphine hydrochloride Product Name: Apomorfina cloridrato Product Code: [APL-130277] INN or Proposed INN: APOMORFINA CLORIDRATO Other descriptive name: Apomorphine hydrochloride | SUNOVION PHARMACEUTICALS INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | France;United States;Canada;Spain;Austria;Germany;United Kingdom;Italy | ||
| 63 | NCT04265027 (ClinicalTrials.gov) | February 20, 2018 | 7/2/2020 | Bioavailability and Bioequivalence Between Two Active Pharmaceutical Ingredient (API) Sources of Opicapone (OPC) | An Open Label, Randomised, Two Period, Crossover Study to Assess Bioavailability, Bioequivalence and S COMT Activity Between Two Active Pharmaceutical Ingredient Sources of Opicapone at Two Different Dosage Strengths (50 mg and 25 mg) After Single and Multiple Dose Administrations Under Fasting Conditions in Healthy Volunteers. | Parkinson Disease | Drug: 50 mg BIA 9 1067;Drug: 25 mg BIA9 1067;Drug: 50 mg Ongentys;Drug: 25 mg Ongentys | Bial - Portela C S.A. | NULL | Completed | 18 Years | 55 Years | All | 72 | Phase 1 | United Kingdom |
| 64 | EUCTR2016-000637-43-ES (EUCTR) | 06/02/2018 | 07/12/2017 | Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease. | An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). | Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes) MedDRA version: 20.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride | Sunovion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | France;United States;Canada;Spain;Austria;Germany;Italy;United Kingdom | ||
| 65 | EUCTR2016-003456-70-ES (EUCTR) | 06/02/2018 | 07/12/2017 | A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patients | An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations | Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 20.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Trade Name: APO-go Product Name: s.c. apomorphine INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE | Sunovion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 85 | Phase 3 | Spain;Austria;United Kingdom | ||
| 66 | EUCTR2016-000637-43-AT (EUCTR) | 01/02/2018 | 15/12/2017 | Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease. | An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). | Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes) MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE | Sunovion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | France;United States;Canada;Spain;Austria;Germany;United Kingdom;Italy | ||
| 67 | NCT02940912 (ClinicalTrials.gov) | January 31, 2018 | 14/10/2016 | Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's Disease | Double Bind Randomized Placebo-controlled Cross-over Study to Evaluate Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's Disease | Parkinson Disease | Drug: Apomorphine;Drug: Placebo | Clinique Beau Soleil | NULL | Active, not recruiting | 35 Years | 90 Years | All | 45 | Phase 4 | France |
| 68 | EUCTR2016-003456-70-AT (EUCTR) | 04/01/2018 | 16/11/2017 | A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patients | An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations | Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Trade Name: APO-go Product Name: s.c. apomorphine INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomor | Sunovion Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 106 | Phase 3 | France;Spain;Austria;Germany;United Kingdom;Italy | ||
| 69 | EUCTR2017-003254-17-ES (EUCTR) | 21/12/2017 | 22/11/2017 | Safety and efficacy of Safinamide (Xadago®) in apathy associated with Parkinson's disease | A 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study to Assess the Effect of Safinamide on Apathy in Patients With Parkinson's Disease | Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Xadago INN or Proposed INN: SAFINAMIDE Other descriptive name: SAFINAMIDE | Institut de Recerca Hospital de la Santa Creu i Sant Pau | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 4 | Spain | ||
| 70 | JPRN-UMIN000030084 | 2017/12/01 | 01/12/2017 | Practical evaluation of PET studies with [18F]-GE180, [18F]-FDOPA and [18F]-FLT for a future clinical trial of iPSC-based cell therapy in Parkinson's disease | Practical evaluation of PET studies with [18F]-GE180, [18F]-FDOPA and [18F]-FLT for a future clinical trial of iPSC-based cell therapy in Parkinson's disease - Practical evaluation of PET studies with three tracers for iPSC derived-neural transplantation | neuroinflammatory disorder, Parkinson's disease, Brain tumor | [18F]GE180 is injected intravenously as 3-4 MBq/Kg. PET is dynamically scanned for 90 minutes. Carbidopa 150mg is administrated orally 1hr before scan.[18F]FDOPA is injected intravenously as 3-4 MBq/Kg. Dynamic PET is scanned for 90 minutes. [18F]FLT is injected intravenously as 3-4 MBq/Kg. Statical PET is scanned after 60 minutes | Kyoto University | NULL | Complete: follow-up complete | 50years-old | Not applicable | Male and Female | 12 | Phase 1,2 | Japan |
| 71 | EUCTR2015-004175-73-FI (EUCTR) | 27/09/2017 | 07/07/2016 | A clinical study to test the safety of CDNF by brain infusion in patients with Parkinson's disease. | A Phase I-II, Randomised, Double-Blind, Placebo Controlled, Safety and Tolerability Study of Intermittent Bilateral Intraputamenal Cerebral Dopamine Neurotrophic Factor (CDNF) Infusions Administered via an Investigational Drug Delivery System to Patients with Idiopathic Parkinson’s Disease (PD) of Moderate Severity. | Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor | Herantis Pharma Plc | NULL | Not Recruiting | Female: yes Male: yes | 17 | Phase 1;Phase 2 | Finland | ||
| 72 | JPRN-jRCTs041180018 | 04/09/2017 | 20/12/2018 | Pupillary autonomic dysfunction and visual hallucination in Parkinson's disease | Association between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease - Pupillary autonomic dysfunction and visual hallucination in Parkinson's disease | Parkinson's disease and related diseases | Two drops of 0.05% pilocarpine hydrochloride, which is a parasympathomimetic agent, on the right eye, 2 drops of 0.04% dipivefrin hydrochloride, which is a sympathomimetic agent, to the left eye | katsuno Masahisa | NULL | Complete | >= 40age old | Not applicable | Both | 40 | Phase 2 | Japan |
| 73 | NCT03292016 (ClinicalTrials.gov) | August 22, 2017 | 11/9/2017 | A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by OFF Episodes | A Comparative Bioavailability Study to Evaluate the Single Dose Pharmacokinetic Properties of APL-130277 With Two Different Formulations of Subcutaneous Apomorphine in a Randomized, 3-Period Crossover Design in Subjects With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) | Parkinson Disease | Drug: APL-130277;Drug: APO-go;Drug: Apokyn | Sunovion | NULL | Completed | 18 Years | N/A | All | 8 | Phase 2 | United States |
| 74 | NCT03187301 (ClinicalTrials.gov) | August 3, 2017 | 7/6/2017 | A Cardiac Safety Study of an Investigational Drug to See How if Affects the Heart in People With Parkinson's Disease Complicated by Motor Fluctuations OFF Episodes | A Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control, QT-Evaluation Study of APL-130277 in Subjects With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) | Parkinson's Disease;Off Episodes of Parkinson Disease | Drug: APL-130277;Drug: Placebo;Drug: Moxifloxacin | Sunovion | NULL | Completed | 18 Years | N/A | All | 48 | Phase 2 | United States;Italy |
| 75 | NCT03973502 (ClinicalTrials.gov) | June 12, 2017 | 30/5/2019 | Application of 18F-FDOPA PET and Magnetic Resonance Spectroscopy (MRS) With HCV and PD | Application of 18F-FDOPA PET and Magnetic Resonance Spectroscopy (MRS) in Research of the Association Between HCV Infection and Parkinson's Disease. | Hepatitis C;Hepatitis B;Parkinson Disease | Drug: 18F-DOPA PET | National Taiwan University Hospital | NULL | Recruiting | 20 Years | N/A | All | 230 | N/A | Taiwan |
| 76 | NCT02702076 (ClinicalTrials.gov) | May 2017 | 2/3/2016 | Apomorphine in Parkinson's Disease Patients With Visual Hallucinations | Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Continuous Subcutaneous Infusion in Parkinson's Disease Patients With Refractory Visual Hallucinations | Parkinson's Disease;Hallucinations, Visual | Drug: Apomorphine;Drug: Placebo | University Medical Center Groningen | NULL | Recruiting | 30 Years | N/A | All | 35 | Phase 2 | Netherlands |
| 77 | NCT03140956 (ClinicalTrials.gov) | April 19, 2017 | 12/4/2017 | Pharmacokinetic of Levodopa Study in Healthy Males | Pharmacokinetics of Levodopa After Repeated Doses of Different Pellet Formulations; An Open, Randomized Study With Crossover Design in Healthy Male Subjects | Parkinson Disease | Drug: Levodopa, carbidopa, ODM-104 | Orion Corporation, Orion Pharma | NULL | Completed | 18 Years | 65 Years | Male | 20 | Phase 1 | Finland |
| 78 | NCT03115827 (ClinicalTrials.gov) | April 18, 2017 | 9/3/2017 | Norepinephrine-targeted Therapy for Action Control in Parkinson Disease | Norepinephrine-targeted Therapy for Action Control in Parkinson Disease | Parkinson Disease | Drug: Droxidopa;Drug: Carbidopa | Vanderbilt University Medical Center | H. Lundbeck A/S;American Academy of Neurology | Completed | 18 Years | N/A | All | 15 | Phase 4 | United States |
| 79 | NCT03128450 (ClinicalTrials.gov) | April 15, 2017 | 9/2/2017 | A Study To Evaluate the Safety and Efficacy of Human Neural Stem Cells for Parkinson's Disease Patient | A Single Arm, Open-Label,Pilot Study to Evaluate the Safety and Efficacy of Human Neural Stem Cells Injection (ANGE-S003) Through Nasal Way Delivery to Patients With Parkinson's Disease | Parkinson Disease | Biological: human neural stem cell | Second Affiliated Hospital of Soochow University | NULL | Enrolling by invitation | 35 Years | 70 Years | All | 12 | Phase 2/Phase 3 | China |
| 80 | EUCTR2016-004629-18-NL (EUCTR) | 13/04/2017 | 17/01/2017 | The influence of stress on Parkinson's tremor | The noradrenergic basis of Parkinson’s tremor: a systems-level fMRI approach - Noradrenergic basis of Parkinson tremor | Tremor in Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Propranolol Product Name: Propranolol HCl CF 40 mg tablet Product Code: RVG 55618 | Radboud University Nijmegen | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Netherlands | ||
| 81 | NCT03011476 (ClinicalTrials.gov) | April 11, 2017 | 27/12/2016 | Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease | Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease Characterized by Postural Instability and Gait Disturbance | Parkinson Disease | Drug: Donepezil;Drug: Placebos | Kyung Hee University Hospital | NULL | Unknown status | 40 Years | 75 Years | All | 20 | Phase 4 | Korea, Republic of |
| 82 | NCT03051607 (ClinicalTrials.gov) | April 10, 2017 | 9/2/2017 | Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease. | A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose Wearing-Off | Idiopathic Parkinson Disease | Drug: Tozadenant | Biotie Therapies Inc. | Acorda Therapeutics | Terminated | 30 Years | 80 Years | All | 66 | Phase 3 | United States;Canada;United Kingdom |
| 83 | JPRN-jRCTs051180185 | 07/04/2017 | 26/03/2019 | APISJ Study | Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease - APISJ Study | Parkinson's disease Parkinson's disease | In this research, the duration of evaluation will be 24 weeks. Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. After the Week 4, the dose will be allowed to be reduced to 20 mg once daily, if the patient exhibits any tolerability issues such as the occurrence of adverse drug reactions caused by Istradefylline. | Takahashi Makio | Kyowa Kirin Co., Ltd. | Complete | >= 30age old | Not applicable | Both | 30 | N/A | Japan |
| 84 | NCT02953665 (ClinicalTrials.gov) | April 3, 2017 | 21/10/2016 | Safety and Efficacy of Liraglutide in Parkinson's Disease | A Phase II, Randomized, Double-blinded, Placebo-controlled Trial of Liraglutide in Parkinson's Disease | Parkinson Disease | Drug: Liraglutide;Drug: Placebo | Cedars-Sinai Medical Center | The Cure Parkinson's Trust;Novo Nordisk A/S | Completed | 25 Years | 85 Years | All | 63 | Phase 2 | United States |
| 85 | EUCTR2016-003456-70-GB (EUCTR) | 22/03/2017 | 26/01/2017 | A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patients | An Open-Label, Randomized, Crossover Trial utilizing a Single-BlindedRater to evaluate APL-130277 compared to s.c. Apomorphine in LevodopaResponsive Subjects with Parkinson's Disease Complicated by MotorFluctuations | Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes) MedDRA version: 21.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Trade Name: APO-go Product Name: s.c. apomorphine INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorp | Sunovion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 106 | Phase 3 | France;Spain;Austria;Germany;Italy;United Kingdom | ||
| 86 | JPRN-UMIN000026492 | 2017/03/15 | 15/03/2017 | Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease | Intervention study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease - Intervention Study of Istradefylline for the Treatment of Abnormal Posture in Patients with Parkinson's Disease. | Parkinson's disease | In this research, the duration of evaluation will be 24 weeks. Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. After the Week 4, the dose will be allowed to be reduced to 20 mg once daily, if the patient exhibits any tolerability issues such as the occurrence of adverse drug reactions caused by istradefylline. | Osaka Red Cross Hospital | Clinical Research Center, Wakayama Medical University | Complete: follow-up complete | 30years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 87 | EUCTR2015-003513-24-SK (EUCTR) | 14/03/2017 | 04/03/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 266 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 88 | JPRN-jRCTs071180014 | 08/03/2017 | 29/01/2019 | ODYSSEI Study | Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease - ODYSSEI Study | Parkinson's disease Parkinson's disease | Arm A: Treatment with Istradefylline combined with optimal medical therapy. Treatment with Istradefylline will be started at a dose of 20 mg administered once daily at Week 0. The dose of Istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. From the following day of Week 4, Optimal medical therapy including Istradefylline will be applied to each patient. Arm B: Optimal medical therapy without Istradefylline. Treatment with increased dose of previously used antiparkinson drugs or addition of new antiparkinson drug other than Istradefylline will be started at Week 0. After Week 4, Optimal medical therapy without Istradefylline will be applied to each patient. | Tsuboi Yoshio | Kyowa Kirin Co., Ltd. | Not Recruiting | >= 30age old | < 80age old | Both | 280 | N/A | N A;Japan |
| 89 | NCT02864004 (ClinicalTrials.gov) | March 3, 2017 | 15/7/2016 | Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP) | Apomorphine Pump in Early Stage of Parkinson's Disease | Parkinson's Disease | Drug: Apomorphine;Other: Best Medical Treatment | Rennes University Hospital | NULL | Recruiting | 18 Years | 65 Years | All | 192 | Phase 3 | France |
| 90 | EUCTR2015-004344-19-DE (EUCTR) | 07/02/2017 | 27/09/2016 | An international trial of deferiprone in patients with Parkinson’s disease | A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 | Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Deferiprone 600 mg delayed release tablet INN or Proposed INN: DEFERIPRONE | ApoPharma | NULL | Not Recruiting | Female: yes Male: yes | 140 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Canada;Germany;United Kingdom | ||
| 91 | JPRN-UMIN000025645 | 2017/02/01 | 17/01/2018 | Cross sectional analysis of Intestinal flora of Parkinson's disease: | Cross sectional analysis of Intestinal flora of Parkinson's disease: - Analysis of Intestinal flora of Parkinson's disease | Parkinson's disease | Levodopa/carbidopa intestinal gel | Juntendo University School of Medicine | NULL | Pending | Not applicable | Not applicable | Male and Female | 20 | Not applicable | Japan |
| 92 | JPRN-UMIN000043848 | 2017/01/10 | 29/04/2021 | The safety and effectiveness of mirabegron in Parkinson's disease patients with overactive bladder | The safety and effectiveness of mirabegron in Parkinson's disease patients with overactive bladder : A randomized controlled trial - SEMPDOABRCT | Overactive bladder | Treatment group receiving daily mirabegron 50mg for 12 weeks Placebo group | Al Zahraa Hospital | NULL | Complete: follow-up complete | 40years-old | 70years-old | Male and Female | 110 | Not applicable | Asia(except Japan) |
| 93 | JPRN-UMIN000024859 | 2016/12/14 | 16/11/2016 | The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide. | The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide. - The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide. | Parkinson's disease | Switching from Dopamine agonist to Zonisamide. Intervention period of 12 weeks. | Medical Corporation Abe Neurology Clinic | NULL | Complete: follow-up continuing | 30years-old | Not applicable | Male and Female | 50 | Not applicable | Japan |
| 94 | JPRN-UMIN000024536 | 2016/11/28 | 25/10/2016 | Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease. | Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease. - ODYSSEI Study(Onset of Dyskinesia and Safety/Efficacy of Istradefylline) | Parkinson's disease | Treatment with istradefylline combined with optimal medical therapy. Treatment with istradefylline will be started at a dose of 20 mg administered once daily at Week 0. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. From the following day of Week 4, Optimal medical therapy including istradefylline will be applied to each patient. Optimal medical therapy without istradefylline. Treatment with increased dose of previously used antiparkinson drugs or addition of new antiparkinson drug other than istradefylline will be started at Week 0. After Week 4, Optimal medical therapy without istradefylline will be applied to each patient. | Fukuoka University | NULL | Complete: follow-up complete | 30years-old | 80years-old | Male and Female | 280 | Not applicable | Japan |
| 95 | EUCTR2016-001690-33-FI (EUCTR) | 25/11/2016 | 23/11/2016 | Apomorfiini-infuusiohoito edenneen Parkinsonin taudin hoidossa | Apomorfiini-infuusiohoito edenneen Parkinsonin taudin hoidossa | Edennyt parkinsonin tauti MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Dacepton 5 mg/ml infuusioneste, liuos Product Name: Dacepton 5 mg/ml | Eero Pekkonen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Finland | |||
| 96 | EUCTR2016-000102-11-NL (EUCTR) | 23/11/2016 | 08/11/2016 | Trial to evaluate the efficacy of continuous subcutaneous apomorphine infusion in Parkinson’s disease patients with refractory visual hallucinations. | Randomized, double-blind, placebo-controlled trial to evaluate the efficacy of continuous subcutaneous apomorphine infusion in Parkinson’s disease patients with refractory visual hallucinations. - Apomorphine in PD patients with visual hallucinations: a RCT | Parkinson's disease patients with refractory visual hallucinations MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: APO-go Product Name: Apomorphine | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2;Phase 3 | Netherlands | |||
| 97 | EUCTR2016-001762-29-IT (EUCTR) | 08/11/2016 | 25/05/2017 | A Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control, QT-Evaluation Study of APL-130277 in Subjects with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes) | A Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control, QT-Evaluation Study of APL-130277 in Subjects with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes) - CTH-201 | Parkinson's Disease (PD) MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: APL-130277 Product Code: APL-130277 INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate Other descriptive name: Apomorphine Hydrocloride Product Name: APL-130277 Product Code: APL-130277 INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate Other descriptive name: Apomorphine Hydrocloride Product Name: APL-130277 Product Code: APL-130277 INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate Other descriptive name: Apomorphine Hydrocloride Product Name: APL-130277 Product Code: APL-130277 INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate Other descriptive name: Apomorphine Hydrocloride Product Name: APL-130277 Product Code: APL-130277 INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate Other descriptive name: Apomorphine Hydrocloride Trade Name: AVALOX - 400 | SUNOVION PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Italy | ||
| 98 | NCT02857244 (ClinicalTrials.gov) | November 2016 | 25/7/2016 | A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients | A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients | Parkinson's Disease | Drug: Duloxetine;Drug: Donepezil;Drug: Modafinil | University of Chicago | NULL | Withdrawn | 18 Years | 100 Years | All | 0 | Phase 2 | United States |
| 99 | EUCTR2016-002454-20-FR (EUCTR) | 17/10/2016 | 16/03/2017 | Apomorphine Pump in Early Stage of Parkinson’s Disease | Apomorphine Pump in Early Stage of Parkinson’s Disease - EARLY-PUMP | Parkinson’s disease MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: APOKINON Product Name: APOKINON | CHU de Rennes | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 3 | France | |||
| 100 | NCT02728843 (ClinicalTrials.gov) | October 12, 2016 | 31/3/2016 | Study of Parkinson's Early Stage With Deferiprone | A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients With Parkinson's Disease | Parkinson's Disease | Drug: Deferiprone;Drug: Placebo | ApoPharma | NULL | Completed | 18 Years | 80 Years | All | 140 | Phase 2 | Canada;France;Germany;United Kingdom |
| 101 | EUCTR2016-002391-27-GB (EUCTR) | 07/10/2016 | 04/08/2016 | Opicapone in clinical practice (OPTIPARK) | This action will amend the information submitted in this data field for all relevant applications. Please refer to the guidance under the Amendment tab and consider whether further notification to review bodies is required. - Opicapone in clinical practice (OPTIPARK)_V1 | Parkinson's disease (PD) patients with wearing-off motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ongentys Product Name: Ongentys | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Germany;United Kingdom | ||
| 102 | EUCTR2015-003513-24-DE (EUCTR) | 08/09/2016 | 15/04/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 266 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 103 | NCT02688465 (ClinicalTrials.gov) | September 5, 2016 | 18/2/2016 | Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE). | Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE). | Parkinson's Disease | Drug: Apomorphine | Fondation Ophtalmologique Adolphe de Rothschild | NULL | Terminated | 18 Years | N/A | All | 15 | Phase 4 | France |
| 104 | NCT02615873 (ClinicalTrials.gov) | July 2016 | 23/11/2015 | A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004 | An Open-Label,Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects Who Completed Study IN 11 004 | Parkinson's Disease | Drug: Accordion Pill™ Carbidopa/Levodopa | Intec Pharma Ltd. | NULL | Unknown status | 30 Years | 100 Years | All | 460 | Phase 3 | United States;Bulgaria;Germany;Israel;Italy;Poland;Slovakia;Spain;Ukraine;United Kingdom |
| 105 | EUCTR2015-004344-19-FR (EUCTR) | 29/06/2016 | 20/04/2016 | An international trial of deferiprone in patients with parkinson’s disease | A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 | Parkinson’s disease MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Deferiprone 600 mg delayed release tablet INN or Proposed INN: DEFERIPRONE | ApoPharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Canada;Germany;Italy;United Kingdom | ||
| 106 | EUCTR2015-003513-24-BG (EUCTR) | 27/06/2016 | 26/04/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 266 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 107 | EUCTR2015-003513-24-IT (EUCTR) | 23/06/2016 | 05/11/2020 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 - OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/400 mg Product Code: [NA] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/500 mg Product Code: [NA] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | INTEC PHARMA LTD | NULL | Not Recruiting | Female: yes Male: yes | 266 | Phase 3 | United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;United Kingdom;Italy | ||
| 108 | EUCTR2015-003512-20-PL (EUCTR) | 22/06/2016 | 01/04/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 109 | EUCTR2015-003512-20-IT (EUCTR) | 08/06/2016 | 05/11/2020 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill¿ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson¿s Disease Patients - Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s Disease | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 MedDRA version: 20.0;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg Product Code: [na] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/400 mg Product Code: [na] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/500 mg Product Code: [na] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | INTEC PHARMA LTD | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Slovakia;Spain;Poland;Ukraine;Russian Federation;Israel;Bulgaria;Germany;United Kingdom;Italy | ||
| 110 | JPRN-UMIN000009062 | 2016/05/30 | 09/10/2012 | An open-label, single-centered, non-randomized trial of inosine to assess its safety for patients with Parkinson's disease | An open-label, single-centered, non-randomized trial of inosine to assess its safety for patients with Parkinson's disease - An evaluation of the safety of inosine for patients with Parkinson's disease | Parkinson's disease | Take oral inosine 500-3000mg/day to achieve a serum UA level between 6.0-8.0 mg/dL | Dept. of Clinical pharmacology and Neurology | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 20 | Phase 1 | Japan |
| 111 | EUCTR2015-003513-24-HU (EUCTR) | 24/05/2016 | 02/03/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 19.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 112 | EUCTR2015-003513-24-ES (EUCTR) | 18/05/2016 | 18/03/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | Parkinson's Disease MedDRA version: 18.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill? Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill? Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 460 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 113 | EUCTR2015-003512-20-ES (EUCTR) | 18/05/2016 | 18/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson?s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill? Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson?s Disease Patients | Parkinson's Disease MedDRA version: 18.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 10-100 Product Name: Immediate Release carbidopa/levodopa 10/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill? Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill? Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 114 | EUCTR2016-000637-43-GB (EUCTR) | 12/05/2016 | 04/03/2016 | Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease. | An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). | Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes) MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE | Sunovion Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;France;Canada;Spain;Austria;Germany;Italy;United Kingdom | ||
| 115 | EUCTR2016-000636-18-GB (EUCTR) | 12/05/2016 | 04/03/2016 | Phase 3, placebo controlled study to examine the efficacy, safety and tolerability of APL-130277 in patients with Parkinson's disease. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). | Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes) MedDRA version: 19.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE Product Name: Apomorphine hydrochloride Product Code: APL-130277 INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: APOMORPHINE HYDROCHLORIDE | Sunuvion Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 3 | Canada;United States;United Kingdom | ||
| 116 | EUCTR2015-003512-20-HU (EUCTR) | 09/05/2016 | 02/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients | Parkinson's Disease MedDRA version: 19.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 10-100 Product Name: Immediate Release carbidopa/levodopa 10/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | Intec Pharma, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 117 | JPRN-UMIN000022187 | 2016/05/06 | 06/05/2016 | Research on Parkinson's disease pathogenesis based on analysis of caffeine absorption in patients with Parkinson's disease | Research on Parkinson's disease pathogenesis based on analysis of caffeine absorption in patients with Parkinson's disease - Analysis of caffeine absorption in patients with Parkinson's disease | Parkinson's disease | PD group, 200 mg caffeine administration, qd, 1 day Control group, 200 mg caffeine administration, qd, 1 day | Department of Neurology, Juntendo University | NULL | Complete: follow-up complete | 40years-old | 60years-old | Male and Female | 20 | Not applicable | Japan |
| 118 | NCT02762591 (ClinicalTrials.gov) | May 3, 2016 | 3/5/2016 | Expanded Access of Pimavanserin for Patients With PD Psychosis | Expanded Access Program of Pimavanserin in Patients With Parkinson's Disease Psychosis | Parkinson's Disease Psychosis | Drug: Pimavanserin tartrate | ACADIA Pharmaceuticals Inc. | NULL | Approved for marketing | 40 Years | N/A | All | N/A | NULL | |
| 119 | EUCTR2015-003513-24-GB (EUCTR) | 28/04/2016 | 04/03/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 266 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 120 | EUCTR2015-003512-20-GB (EUCTR) | 28/04/2016 | 03/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 121 | EUCTR2015-003512-20-SK (EUCTR) | 22/04/2016 | 04/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 10-100 Product Name: Immediate Release carbidopa/levodopa 10/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 122 | NCT03034538 (ClinicalTrials.gov) | April 8, 2016 | 25/1/2017 | An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease | An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease | Parkinson Disease;Parkinsonism;Dyskinesias | Drug: Zonegran | The Cooper Health System | NULL | Suspended | 18 Years | N/A | All | 20 | Phase 4 | United States |
| 123 | NCT02764125 (ClinicalTrials.gov) | April 8, 2016 | 13/1/2016 | Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off (COMPOC) | Efficacy and Safety of ODM-104 Compared to a Standard Combination (Stalevo®); a Randomized Double-blind, Crossover Proof-of-concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off | Parkinson's Disease | Drug: Stalevo;Drug: levodopa MR | Orion Corporation, Orion Pharma | NULL | Completed | 30 Years | N/A | All | 84 | Phase 2 | Finland;Germany;Hungary;Latvia |
| 124 | NCT02775591 (ClinicalTrials.gov) | April 2016 | 9/5/2016 | Effect of Short-term Motilitone Therapy on Health-related Quality of Life in PD Patients With Gastrointestinal Symptoms | Effect of Short-term Motilitone Therapy on Health-related Quality of Life in Parkinson's Disease Patients With Gastrointestinal Symptoms: a Multicenter, Double-blind Randomized, Placebo-controlled Trial | Parkinson Disease;Dyspepsia | Drug: DA-9701;Drug: DA-9701 placebo | Seoul National University Hospital | Samsung Medical Center;Korea University Guro Hospital;Hanyang University;Seoul Veterans Hospital;SMG-SNU Boramae Medical Center | Completed | 50 Years | 80 Years | All | 147 | Phase 4 | Korea, Republic of |
| 125 | NCT02729714 (ClinicalTrials.gov) | April 2016 | 26/1/2016 | A Pilot Study of Suvorexant for Insomnia in Parkinson Disease | A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Suvorexant for Insomnia in Parkinson Disease | Insomnia | Drug: Suvorexant;Drug: Placebo | Burdick, Daniel, M.D. | Merck Sharp & Dohme LLC | Completed | 30 Years | 80 Years | All | 20 | Phase 4 | United States |
| 126 | NCT03173781 (ClinicalTrials.gov) | April 2016 | 10/8/2016 | Effects of Droxidopa When Measuring Gait Speed, Kyphosis, and Functional Reach in Parkinson's Disease | Effects of Droxidopa When Measuring Gait Speed, Kyphosis, and Functional Reach in Parkinson's Disease | Parkinson's Disease | Drug: droxidopa;Drug: Placebo | Colorado Springs Neurological Associates | H. Lundbeck A/S | Completed | 18 Years | N/A | All | 21 | N/A | United States |
| 127 | NCT02719496 (ClinicalTrials.gov) | April 2016 | 15/3/2016 | Prove of Concept Study, to Evaluate the Efficacy, Safety, and Tolerability of IBEROGAST in the Treatment of Bowel Troubles in Patients With Parkinson's Disease | Prove of Concept Study, to Evaluate the Efficacy, Safety, and Tolerability of IBEROGAST in the Treatment of Bowel Troubles in Patients With Parkinson's Disease | Gastrointestinal Disorders in Parkinson's Disease | Drug: IBEROGAST | Nantes University Hospital | NULL | Completed | 30 Years | 80 Years | All | 45 | Phase 2 | France |
| 128 | EUCTR2015-004344-19-GB (EUCTR) | 31/03/2016 | 16/02/2016 | An international trial of deferiprone in patients with Parkinson’s disease | A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 | Parkinson’s disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Deferiprone 600 mg delayed release tablet INN or Proposed INN: DEFERIPRONE | ApoPharma | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | France;Canada;Germany;United Kingdom | ||
| 129 | JPRN-jRCTs061180060 | 22/03/2016 | 18/03/2019 | Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's disease | Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease - Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease | Parkinson's disease;D010300 | Inosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years or placebo (500mg/CP) | Nagai Masahiro | NULL | Complete | >= 20age old | Not applicable | Both | 100 | Phase 2 | Japan |
| 130 | NCT02605434 (ClinicalTrials.gov) | March 2016 | 5/11/2015 | A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients | Phase 3 Multicenter Randomized Double-Blind, Double-dummy, Active-Controlled Study Comparing Efficacy/Safety of Gastric-retentive, Controlled-release Accordion Pill Carbidopa/Levodopa to Immediate Release in Fluctuating Parkinson's Patients | Parkinson's Disease | Drug: Accordion Pill™ Carbidopa/Levodopa;Drug: Sinemet®;Drug: Placebo -AP-CD/LD;Drug: Placebo- Sinemet | Intec Pharma Ltd. | NULL | Unknown status | 30 Years | N/A | All | 420 | Phase 3 | United States;Bulgaria;Germany;Israel;Italy;Poland;Slovakia;Spain;Ukraine;United Kingdom;Hungary |
| 131 | NCT02655315 (ClinicalTrials.gov) | February 9, 2016 | 7/1/2016 | Conservative Iron Chelation as a Disease-modifying Strategy in Parkinson's Disease | Conservative Iron Chelation as a Disease-modifying Strategy in Parkinson's Disease. European Multicentre, Parallel-group, Placebo-controlled, Randomized Clinical Trial of Deferiprone | Parkinson Disease | Drug: Deferiprone;Drug: Placebo | University Hospital, Lille | European Commission;ApoPharma | Completed | N/A | 80 Years | All | 372 | Phase 2 | Austria;Czechia;France;Germany;Netherlands;Portugal;Spain;United Kingdom;Czech Republic |
| 132 | JPRN-UMIN000020527 | 2016/02/01 | 01/02/2016 | Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease | Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease - Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's disease | Parkinson's disease | Inosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years Lactose as a placebo for 2 years | Ehime University Graduate School of Medicine | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 100 | Phase 2 | Japan |
| 133 | JPRN-UMIN000020288 | 2016/02/01 | 28/12/2015 | Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease. | Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease. - Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease. | Parkinson's disease | In this research, the duration of evaluation will be 12 weeks. Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. After the Week 4, the dose will be allowed to be reduced to 20 mg once daily, if the patient exhibits any tolerability issues such as the occurrence of adverse drug reactions caused by istradefylline. | Juntendo University Shizuoka Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 134 | NCT02549573 (ClinicalTrials.gov) | January 2016 | 9/9/2015 | Outpatient Physical Therapy Intervention in Subjects With Parkinson's Disease Currently Using APOKYN® | Outpatient Physical Therapy Intervention in Subjects With Parkinson's DiseaseCurrently Using APOKYN®: A Phase IV Study of Outcome Assessments of Physical Therapy in Subjects in an On Versus End-of-Dose-Off Motor State | Parkinson's Disease;Motor Symptoms | Drug: APOKYN;Behavioral: Physical Therapy | US WorldMeds LLC | NULL | Terminated | 18 Years | 78 Years | All | 13 | Phase 4 | United States |
| 135 | JPRN-UMIN000019654 | 2015/11/06 | 06/11/2015 | The effect of rich-hydrogen water drinking to gut peptide | The effect of rich-hydrogen water drinking to gut peptide - The effect of rich-hydrogen water drinking to gut peptide | Parkinson's disease, healthy control | hydrogen water natural water | Nagoya graduate school of medicine university | NULL | Pending | 20years-old | 80years-old | Male and Female | 40 | Not applicable | Japan |
| 136 | JPRN-jRCTs041180070 | 04/11/2015 | 07/03/2019 | Trerief Impact in PD PET Study | Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - TIPPS | Parkinson's disease Parkinson's disease;D010300 | [1] Zonisamide treatment group Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms. [2] Zonisamide non-treatment group Only levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms. | Ouchi Yasuomi | NULL | Not Recruiting | Not applicable | < 80age old | Both | 20 | N/A | Japan |
| 137 | JPRN-UMIN000019082 | 2015/10/10 | 22/09/2015 | the effect of smell dysfunction using hydrogen gas for parkinson disease | the effect of smell dysfunction using hydrogen gas for parkinson disease - the effect of smell dysfunction using hydrogen gas for parkinson disease | parkinson's disease | we measured smell test and urine 8-OHdG before and after 3.5% hydrogen gas. After two month discontinuation of administration. we measured smell test and urine 8-OHdG before and after room air. we measured smell test and urine 8-OHdG before and after room air. After two month discontinuation of administration. we measured smell test and urine 8-OHdG before and after 3.5% hydrogen gas. | Nagoya University Graduate School of Medicine | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 20 | Not selected | Japan |
| 138 | JPRN-UMIN000019524 | 2015/10/01 | 28/10/2015 | Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images | Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - Trerief Impact in PD PET Study (TIPPS) | Parkinson's Disease | Zonisamide treatment group: Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms. Zonisamide non-treatment group: Only Levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms. | Hamamatsu University School of Medicine | NULL | Complete: follow-up complete | Not applicable | 80years-old | Male and Female | 20 | Not applicable | Japan |
| 139 | NCT02542696 (ClinicalTrials.gov) | August 31, 2015 | 3/9/2015 | Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease | An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) | Parkinson Disease | Drug: APL-130277 | Sunovion | NULL | Completed | 18 Years | N/A | All | 427 | Phase 3 | United States;Austria;Canada;France;Germany;Italy;Spain;United Kingdom |
| 140 | EUCTR2014-000657-36-NL (EUCTR) | 22/06/2015 | 03/06/2015 | Trial to investigate the efficacy of treatments in apomorphine-induced skin reactions | Open-label crossover trial to investigate the efficacy of treatments in apomorphine-induced skin reactions - Treatment of apomorphine-induced skin reactions: a pilot study | Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hydrocortisone cream 10mg/g FNA Fagron Product Name: Hydrocortisone cream Trade Name: Solu-Cortef, powder for solution for injection, 100mg, and 'Act-O-Vial' Product Name: Solu-Cortef Trade Name: APO-go Product Name: Apomorphine | University Medical Center Groningen | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Netherlands | ||
| 141 | NCT02469090 (ClinicalTrials.gov) | June 18, 2015 | 9/6/2015 | Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease | Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) | Parkinson Disease, Off Episodes | Drug: APL-130277;Drug: Placebo | Sunovion | NULL | Completed | 18 Years | N/A | All | 141 | Phase 3 | United States;Canada;United Kingdom |
| 142 | NCT02230930 (ClinicalTrials.gov) | June 2015 | 29/8/2014 | Treatment of Apomorphine-induced Skin Reactions: a Pilot Study | Open-label Crossover Trial to Investigate the Efficacy of Treatments in Apomorphine-induced Skin Reactions | Parkinson's Disease;Apomorphine-induced Skin Reactions | Drug: Apomorphine 0.25% (2.5mg/ml);Device: Massage with a spiky ball;Drug: Hydrocortisone cream 1%;Drug: Subcutaneous hydrocortisone 10mg | University Medical Center Groningen | NULL | Recruiting | 30 Years | N/A | All | 20 | Phase 2 | Netherlands |
| 143 | NCT02439203 (ClinicalTrials.gov) | May 2015 | 30/4/2015 | Efficacy and Safety of JM-010 in PD With Levodopa-Induced Dyskinesia | A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study in Subjects With Parkinson's Disease With Moderate to Severe Levodopa-induced Dyskinesia, to Assess the Efficacy, Safety/Tolerability and Pharmacokinetics of JM-010 | Parkinson's Disease;Levodopa Induced Dyskinesia (LID) | Drug: JM-010;Drug: Placebo | Bukwang Pharmaceutical | Contera Pharma ApS | Completed | 18 Years | N/A | Both | 30 | Phase 2 | South Africa |
| 144 | NCT02418598 (ClinicalTrials.gov) | April 14, 2015 | 12/4/2015 | AADC Gene Therapy for Parkinson's Disease | A Phase I /II Study of Intra-putaminal Infusion of Adeno-Associated Virus Encoding Human Aromatic L-Amino Acid Decarboxylase in Subjects With Parkinson's Disease | Parkinson Disease | Genetic: Cohort1;Genetic: Cohort2 | Jichi Medical University | Takara Bio Inc.;Gene Therapy Research Institution,Co.,Ltd. | Terminated | 35 Years | 75 Years | All | 2 | Phase 1/Phase 2 | Japan |
| 145 | JPRN-UMIN000017036 | 2015/04/03 | 03/04/2015 | Association of ghrelin and leptin in cardiovascular autonomic dysfunction in patients with primary dysautonomia. | Association of ghrelin and leptin in cardiovascular autonomic dysfunction in patients with primary dysautonomia. - Association of ghrelin and leptin in cardiovascular autonomic dysfunction | autonomic failure such as Parkinson's disease | blood test of Leptin and Ghrelin blood test of Leptin and Ghrelin | Nagoya University Graduate School of Medicine | NULL | Complete: follow-up complete | 40years-old | Not applicable | Male and Female | 50 | Not applicable | Japan |
| 146 | JPRN-UMIN000016591 | 2015/04/01 | 20/02/2015 | Clinical trial of balance exercise "Assist" | Clinical trial of balance exercise "Assist" - Balance Exercise Assist | Stroke, Parkinson disease, Osteoarthrosis | use of balance exercise assist ordinary balance exercise | Juntendo University | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 40 | Not applicable | Japan |
| 147 | NCT02424708 (ClinicalTrials.gov) | April 2015 | 15/4/2015 | Phase IIb Study of Intranasal Glutathione in Parkinson's Disease | Phase IIb Study of Intranasal Glutathione in Parkinson's Disease | Parkinson's Disease | Drug: Reduced Glutathione 100mg;Drug: Reduced Glutathione 200mg;Drug: Placebo | Bastyr University | Michael J. Fox Foundation for Parkinson's Research | Completed | 21 Years | N/A | Both | 45 | Phase 2 | United States |
| 148 | NCT02390089 (ClinicalTrials.gov) | April 2015 | 19/2/2015 | Cough According to Stimulus Type in PD | Airway Protection Deficits According to Stimulus Type in Parkinson's Disease | Parkinson's Disease | Drug: Capsaicin vapor;Other: fog;Radiation: Videofluoroscopic swallow evaluation;Device: Nebulizer | University of Florida | National Institute on Deafness and Other Communication Disorders (NIDCD) | Completed | 50 Years | 80 Years | All | 158 | Phase 1 | United States |
| 149 | NCT02359448 (ClinicalTrials.gov) | April 2015 | 4/2/2015 | Melatonin for Nocturia in Parkinson's Disease | Single-centre Open Label Exploratory Phase IIb Pilot Study of Exogenous Oral Melatonin for the Treatment of Nocturia in Adults With Parkinson's Disease | Parkinson's Disease;Nocturia | Drug: Melatonin | University College, London | NULL | Not yet recruiting | 18 Years | N/A | Both | 20 | Phase 2 | United Kingdom |
| 150 | NCT02486432 (ClinicalTrials.gov) | April 2015 | 22/6/2015 | A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa) | A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa) Doses Administered Using a Divided Dose Approach | Parkinson's Disease | Drug: Levodopa/Carbidopa (Sinemet) | NeuroDerm Ltd. | Quotient Clinical | Completed | 40 Years | 65 Years | Both | 6 | Phase 1 | NULL |
| 151 | JPRN-UMIN000016664 | 2015/03/01 | 01/03/2015 | Effect of nicotine patch in Cognitive function improvement in Parkinson's disease | Effect of nicotine patch in Cognitive function improvement in Parkinson's disease - Effect of nicotine patch in Cognitive function improvement | Parkinson's disease | nicotine patch | Department of Clinical Pharmacology and Neurology Ehime University graduated School of Medicine | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 20 | Not selected | Japan |
| 152 | JPRN-UMIN000016485 | 2015/02/25 | 09/02/2015 | Pilot study about imaging method of 18F-fluoro-dopa and 11C-raclopride in Parkinson's disease and Parkinson's syndrome | Pilot study about imaging method of 18F-fluoro-dopa and 11C-raclopride in Parkinson's disease and Parkinson's syndrome - PD-1 | Healthy subjects, Parkinson's disease patients and Parkinson's syndrome patients | Intravenous injection of 18F-fluoro-dopa and 11C-raclopride PET imaging | Institute of Biomedical Research and Innovation | NULL | Complete: follow-up complete | 35years-old | Not applicable | Male and Female | 20 | Not selected | Japan |
| 153 | NCT02339064 (ClinicalTrials.gov) | February 2015 | 31/3/2014 | Infusion of Apomorphine: Long-term Safety Study | A Phase 3, Open-Label Study of the Safety, Efficacy and Tolerability of Apomorphine Administered by Continuous Subcutaneous Infusion in Advanced Parkinson's Disease Patients With Unsatisfactory Control on Available Therapy | Idiopathic Parkinson's Disease | Drug: apomorphine infusion | US WorldMeds LLC | NULL | Active, not recruiting | 30 Years | N/A | All | 99 | Phase 3 | United States |
| 154 | ChiCTR-DDD-17010794 | 2014-11-08 | 2017-03-05 | The study on early diagnosis of Parkinson 's disease by transcranial ultrasonography | the study on early diagnosis of Parkinson 's disease by transcranial ultrasonography | Parkinson's Disease | Gold Standard:Diagnosis of Parkinson disease needs to meet 3 or more: unilateral onset;resting tremor;progressive course; long term asymmetry, the most obvious symptoms is the onset side; a good response to levodopa (70% ~ 100%); levodopa induced chorea; a reaction of levodopa lasts 5 years or more; clinical course last;Index test:Laboratory apparatus As shown in Figure 1, The ultrasound equipment, Philips IE33-BOMJH1 color Doppler ultrasonography, Model IE-ELite, with 2-4MHz phased array probe (S5-1 probe) was used for TCS to examine SN in our study. Transcranial ultrasound study Ultrasonography through temporal window, alon; | Department of Neurology, Fujian Institute of Geriatrics, Fujian Medical University Union Hospital | NULL | Completed | 36 | 84 | Both | Target condition:135;Difficult condition:0 | China | |
| 155 | NCT02274324 (ClinicalTrials.gov) | October 2014 | 22/10/2014 | Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson&Apos;s Disease | Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson's Disease | Parkinson Disease | Dietary Supplement: different diets | Sheba Medical Center | Tel Aviv University | Not yet recruiting | 40 Years | 80 Years | Both | 20 | N/A | NULL |
| 156 | JPRN-UMIN000016893 | 2014/09/22 | 01/04/2015 | A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression. | A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression. - Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine. | PD patients | The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule. The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule. | Ehime University HospitalDept. of Clinical pharmacology and Neurology | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 50 | Phase 2 | Japan |
| 157 | NCT02228590 (ClinicalTrials.gov) | August 31, 2014 | 26/8/2014 | A Study to Examine APL-130277 in Patients With Parkinson's Disease | A Phase 2 Study to Examine the Safety, Tolerability and Efficacy of APL-130277 in Patients With Parkinson's Disease | Parkinson's Disease | Drug: APL-130277 | Sunovion | NULL | Completed | 18 Years | 80 Years | All | 20 | Phase 2 | United States |
| 158 | JPRN-UMIN000014709 | 2014/07/01 | 01/08/2014 | Study on Parkinson's disease and related disorders with dopamine transporter ligand [C-11]PE2I | Study on Parkinson's disease and related disorders with dopamine transporter ligand [C-11]PE2I - DAT PET with [C-11]PE2I in PD and related disorders | Patients of Parkinson's disease and related disorders | The dosage in the vein of [C-11]PE2I, [C-11]raclopride, and [F-18]FDG for PET/CT imaging. | Tokyo Metropolitan Institute of Gerontology | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 200 | Not selected | Japan |
| 159 | EUCTR2013-000980-10-DK (EUCTR) | 06/06/2014 | 09/01/2014 | Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s disease | TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO | Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Spain;Austria;Denmark;Netherlands;Germany | ||
| 160 | NCT02365012 (ClinicalTrials.gov) | April 2014 | 10/2/2015 | Treatment of Orthostatic Intolerance in Patients With Parkinson's Disease Using Midodrine | Treatment of Orthostatic Intolerance in Patients With Parkinson's Disease Using Midodrine | Orthostatic Intolerance;Parkinson's Disease | Drug: Midodrine | Philadelphia Veterans Affairs Medical Center | NULL | Recruiting | 22 Years | 89 Years | Both | 50 | N/A | United States |
| 161 | NCT02111122 (ClinicalTrials.gov) | April 2014 | 8/4/2014 | Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease | A Phase II, Prospective, Randomized, Double-blind, Crossover Placebo-controlled Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease | Sleep-wake Disturbances in Motor-phase Parkinson's Disease | Drug: Sodium Oxybate;Drug: Placebo | Christian Baumann | NULL | Completed | 18 Years | 90 Years | All | 16 | Phase 2 | Switzerland |
| 162 | NCT02091739 (ClinicalTrials.gov) | April 2014 | 18/3/2014 | Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions | Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Multicenter Study, With an Extension Period of Dose-blinded Active Treatment, to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions | Chronic Troublesome Sialorrhea;Parkinson's Disease;Post-stroke;Traumatic Brain Injury | Drug: IncobotulinumtoxinA (100 Units);Drug: IncobotulinumtoxinA (75 Units);Drug: Placebo | Merz Pharmaceuticals GmbH | NULL | Completed | 18 Years | 80 Years | All | 184 | Phase 3 | Germany;Poland;United States |
| 163 | NCT01738178 (ClinicalTrials.gov) | April 2014 | 28/11/2012 | Caffeine as a Therapy for Parkinson's Disease | Caffeine as a Therapeutic Agent in Parkinson's Disease | Parkinson's Disease | Drug: Caffeine;Drug: Placebo | McGill University Health Center | Pontifícia Universidade Católica do Paraná;University of Calgary;University of Newfoundland and Eastern Health;University Health Network, Toronto;UBC Hospital;Movement Disorder Clinic - Deer Lodge Centre;The Ottawa Hospital | Completed | 45 Years | 75 Years | All | 119 | Phase 3 | Brazil;Canada |
| 164 | NCT02741947 (ClinicalTrials.gov) | April 2014 | 31/3/2016 | Levodopa Benserazide Generic Formulation Versus the Originator | Clinical and Pharmacokinetics Study to Evaluate the Therapeutic Equivalence and Bioequivalence of Levodopa Benserazide Generic Formulation (Teva Italia) Versus the Originator (Madopar®) | Parkinson Disease | Drug: Levodopa Benserazide Madopar;Drug: Levodopa Benserazide Teva Italia | IRCCS San Raffaele | Agenzia Italiana del Farmaco | Completed | 30 Years | 75 Years | Both | 44 | Phase 4 | Italy |
| 165 | EUCTR2013-000980-10-FR (EUCTR) | 03/03/2014 | 22/11/2013 | Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s disease | TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO | Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 16.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride | STADA Arzneimittel AG | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Spain;Denmark;Austria;Netherlands;Germany | ||
| 166 | NCT02006121 (ClinicalTrials.gov) | March 3, 2014 | 22/11/2013 | Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's Disease | Multicentre,Parallel-group,Double-blind,Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Apomorphine sc Infusion in Parkinson's Disease Patients With Motor Complications Not Well Controlled on Medical Treatment | Parkinson's Disease | Drug: Apomorphine hydrochloride;Drug: Placebo | Britannia Pharmaceuticals Ltd. | NULL | Completed | 30 Years | N/A | All | 107 | Phase 3 | Austria;Denmark;France;Germany;Netherlands;Spain;United Kingdom |
| 167 | EUCTR2013-000980-10-ES (EUCTR) | 12/02/2014 | 12/11/2013 | Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson?s disease | TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson?s disease patients with motor complications not well controlled on medical treatment - TOLEDO | Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 16.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride | STADA Arzneimittel AG | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Spain;Denmark;Austria;Netherlands;Germany | ||
| 168 | EUCTR2013-000980-10-NL (EUCTR) | 06/02/2014 | 27/01/2014 | Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s disease | TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO | Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Spain;Denmark;Austria;Germany;Netherlands | ||
| 169 | EUCTR2012-002840-26-RO (EUCTR) | 12/11/2013 | 17/07/2014 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria | ||
| 170 | NCT01856738 (ClinicalTrials.gov) | November 2013 | 14/5/2013 | Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson&Apos;s Disease | Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson's Disease:a Multi-center Placebo-controlled Trial. | Parkinson's Disease | Drug: Rivastigmine;Drug: Placebo (for rivastigmine) | VU University Medical Center | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA);Atrium Medical Center;University Medical Center Groningen;Leiden University Medical Center;University Medical Center Nijmegen;International Parkinson Fonds Germany GmbH;ZonMw: The Netherlands Organisation for Health Research and Development | Terminated | 40 Years | N/A | All | 91 | Phase 4 | Netherlands |
| 171 | EUCTR2013-000980-10-AT (EUCTR) | 18/10/2013 | 31/07/2013 | Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s disease | TOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO | Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Apo-go® Product Name: Apomorphine hydrochloride Product Code: Apo-go® INN or Proposed INN: Apomorphine hydrochloride Other descriptive name: Apomorphine hydrochloride | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Spain;Denmark;Austria;Netherlands;Germany | ||
| 172 | JPRN-UMIN000011111 | 2013/07/16 | 15/07/2013 | Spinal blood flow and metabolism in neurological diseases | Spinal blood flow and metabolism in neurological diseases - Spinal blood flow and metabolism in neurological diseases | motor neuron disease including ALS, multiple sclerosis, stroke, Parkinson disease, spinocerebellar degeneration, multiple system atrophy | PET scan study with 11C-flumazenil PET scan study with 18F- FDG PET scan study with 15O-H2O | Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 70 | Not applicable | Japan |
| 173 | NCT01765257 (ClinicalTrials.gov) | June 2013 | 8/1/2013 | Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study | Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study. | Drug-naïve Patients With Parkinson's Disease;Apathy | Drug: AZILECT®;Drug: Placebo | University Hospital, Clermont-Ferrand | H. Lundbeck A/S, TEVA;CHU Purpan (Toulouse);Hôpital Haut-Levêque (Pessac);Centre Hospitalier de la Côte Basque;Centre Hospitalier Universitaire de Poitiers (Poitiers);CHU de Rennes (Rennes);University Hospital, Lille;CHU Dupuytren (Limoges);University Hospital, Caen;Hôpital Caremeau (NIMES);Centre Hospitalier Pays D'Aix;Hôpital de la Timone (MARSEILLE);University Hospital, Rouen;Centre Hospitalier Universitaire, Amiens;Centre Hospitalier Universitaire de Saint Etienne;Fondation Rothschild Paris | Not yet recruiting | 30 Years | 70 Years | Both | 50 | Phase 4 | France |
| 174 | JPRN-UMIN000010752 | 2013/05/17 | 17/05/2013 | A study on usefulness and safety of donepezil for cognitive function and phychological symptoms of patients with Parkinson's disease and Alzheimer type dementia. | A study on usefulness and safety of donepezil for cognitive function and phychological symptoms of patients with Parkinson's disease and Alzheimer type dementia. - Donepezil study on Parkinson\'s disease with dementia | Parkinson's disease | donepezil | Kansai Medical University | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 50 | Not selected | Japan |
| 175 | JPRN-UMIN000010596 | 2013/05/01 | 01/05/2013 | Randomized crossover trial comparing memantine or amantadine for Parkinson's disease with motor fluctuations in Juntendo | Randomized crossover trial comparing memantine or amantadine for Parkinson's disease with motor fluctuations in Juntendo - MAP-J | Parkinson's disease | Memantine preceding arm Titrate the memantine, administered for 3 months. And tapering memantine and amantadine titrate the dose for 3 months. Amantadine preceding arm Titrate the amantadine, administered for 3 months. And tapering amantadine and memantine titrate the dose for 3 months. | Department of Neurology, Juntendo University School of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male | 40 | Not selected | Japan |
| 176 | EUCTR2012-002840-26-BG (EUCTR) | 26/04/2013 | 06/02/2013 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria | ||
| 177 | JPRN-UMIN000010778 | 2013/04/10 | 22/05/2013 | Delayed start study of donepezil hydrocloride for cognitive decline in Parkinson disease following EDAP-1 | Delayed start study of donepezil hydrocloride for cognitive decline in Parkinson disease following EDAP-1 - EDAP-2 | Parkinson disease | 5mg donepezil hydrocloride | National Hospital of Utano | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 50 | Not selected | Japan |
| 178 | JPRN-UMIN000010371 | 2013/04/08 | 01/04/2013 | Study of zonisamide ( TRERIEF® tablet 25mg ) to tremor in patients with early Parkinson's disease. | Study of zonisamide ( TRERIEF® tablet 25mg ) to tremor in patients with early Parkinson's disease. - Study of zonisamide to tremor in patients with early Parkinson's disease. | Parkinson's disease | Start 25mg of Zonisamide and carry out observation 24weeks. Evaluate start point, after 4weeks, after 8weeks, after 16weeks, and after 24weeks. | Department of Neurology, University of Yamanashi | NULL | Pending | Not applicable | Not applicable | Male and Female | 10 | Not selected | Japan |
| 179 | NCT02005029 (ClinicalTrials.gov) | April 2013 | 18/9/2013 | Erythromycin in Parkinson's Disease | Erythromycin in Parkinson's Disease: A Pilot Study of Its Effects on Levodopa Pharmacokinetics and Pharmacodynamics | Parkinson's Disease;Levodopa | Drug: Erythromycin;Drug: placebo | Virginia Commonwealth University | NULL | Completed | 18 Years | 80 Years | All | 18 | N/A | United States |
| 180 | NCT01777555 (ClinicalTrials.gov) | April 2013 | 23/1/2013 | Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes | A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) | Idiopathic Parkinson's Disease | Drug: CVT-301;Drug: Placebo | Acorda Therapeutics | NULL | Completed | 30 Years | 80 Years | All | 89 | Phase 2 | United States;Italy;Serbia;United Kingdom |
| 181 | NCT01829867 (ClinicalTrials.gov) | April 2013 | 9/4/2013 | A Study With an Increased Dose Step in Patients That Have Previously Received Placebo or sNN0031. | A Phase I, Open-label Study in Patients With Parkinson's Disease to Further Assess Safety and Tolerability of sNN0031 Administered at the Total Dose of 95 µg by Intracerebroventricular Infusion | Parkinson's Disease | Drug: sNN0031 | Newron Sweden AB | NULL | Terminated | 55 Years | 75 Years | Both | 5 | Phase 1 | Sweden |
| 182 | EUCTR2012-002840-26-SI (EUCTR) | 26/03/2013 | 18/03/2013 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | United States;Serbia;Slovenia;Slovakia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria | ||
| 183 | JPRN-UMIN000009958 | 2013/03/08 | 01/03/2013 | Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction | Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction - Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction | Parkinson's disease | Donepezil hydrochloride added to standard therapy Placebo added to standard therapy | National Hospital Organization, Sendai-Nishitaga Hospital | NULL | Complete: follow-up complete | 55years-old | 75years-old | Male and Female | 200 | Not applicable | Japan |
| 184 | EUCTR2012-002840-26-AT (EUCTR) | 05/03/2013 | 06/11/2012 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | United States;Serbia;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria | ||
| 185 | JPRN-UMIN000046104 | 2013/03/01 | 21/11/2021 | Research for the development of assessment strategy and treatment for cognitive impairment of Parkinson's disease | Neuroimaging study for the assessment and treatment of cognitive impairment of the patients with Parkinson's disease - RCIP-Nagoya Study: Research for the cognitive impairment of Parkinson's disease in Nagoya | Parkinson's disease | This study followed a randomized double-blind crossover design for the patients with mild cognitive impairments in PD. Patients in the memantine group were given memantine at 5 mg/day in the first week, and the dose was increased by 5 mg/day per week, with the final dose of 20 mg/day. The patients in the placebo group were given a placebo following the same regimen. During maximum dose administration, fMRI scanning and neuropsychological tests were performed. Group comparisons between memantine and placebo were performed to explore the significant differences. | Nagoya City University | NULL | Complete: follow-up complete | 60years-old | 75years-old | Male and Female | 12 | Not applicable | Japan |
| 186 | JPRN-UMIN000010014 | 2013/02/28 | 13/02/2013 | Randomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson Disease | Randomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson Disease - Randomized Double-blind, Placebo-controlled trial on hydrogen water in Parkinson Disease | Parkinson's disesase | hydrogen water made by "Suisosui5.0" placebo-water (nitrogen filling water) | Juntendo University School of Medicine, Neurology | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 200 | Not selected | Japan |
| 187 | EUCTR2012-002840-26-IT (EUCTR) | 18/02/2013 | 11/01/2013 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-ARM, PHASE 4 STUDY TO EVALUATE THE EFFICACY OF ROTIGOTINE ON PARKINSON’S DISEASE-ASSOCIATED APATHY, MOTOR SYMPTOMS, AND MOOD | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro INN or Proposed INN: ROTIGOTINE | UCB BIOSCIENCES GMBH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 4 | United States;Hungary;Slovenia;Spain;Ukraine;Turkey;Austria;Bulgaria;Russian Federation;Italy | ||
| 188 | EUCTR2012-002840-26-HU (EUCTR) | 11/02/2013 | 13/12/2012 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria | ||
| 189 | NCT01782222 (ClinicalTrials.gov) | February 2013 | 30/1/2013 | Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And Apathy | A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 3-Arm, Phase 4 Study To Evaluate The Efficacy Of Rotigotine On Parkinson's Disease-Associated Apathy, Motor Symptoms, And Mood | Idiopathic Parkinson's Disease | Drug: Rotigotine;Other: Placebo | UCB BIOSCIENCES GmbH | NULL | Completed | 18 Years | N/A | All | 122 | Phase 4 | United States;Austria;Hungary;Poland;Slovakia;Slovenia;Spain |
| 190 | EUCTR2012-002840-26-ES (EUCTR) | 23/01/2013 | 29/11/2012 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria | ||
| 191 | EUCTR2012-002840-26-SK (EUCTR) | 07/01/2013 | 09/03/2016 | Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's Disease | A Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood | Parkinson's disease MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE Trade Name: Neupro Product Name: Rotigotine INN or Proposed INN: ROTIGOTINE | UCB Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 504 | Phase 4 | Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria | ||
| 192 | JPRN-UMIN000017695 | 2013/01/01 | 27/05/2015 | Oxybuprocaine for apraxia of lid opening in Parkinson's disease | Oxybuprocaine for apraxia of lid opening in Parkinson's disease - Oxybuprocain for ALO | apraxia of lid opening in Parkinson's disease | Arm 1 intervention consisted of 4%oxybuprocaine eye drop treatment, washout for 24 hours or more, and a saline eye drop treatment Arm 2 intervention consisted of saline eye drop treatment, a washout period, and an oxybuprocaine treatment | Utano National Hospital, National Hospital Organization | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 10 | Not selected | Japan |
| 193 | NCT01770145 (ClinicalTrials.gov) | December 2012 | 7/1/2013 | Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT) | A Phase 4, Open-Label, Efficacy and Safety Study of Apokyn® for Rapid and Reliable Improvement of Motor Symptoms in Parkinson Disease Subjects With Delayed Onset of L-Dopa Action | Parkinson's Disease;Motor Symptoms;Akinesia;Hypomobility;Delayed Levodopa Onset | Drug: APOKYN;Drug: L-dopa;Drug: Trimethobenzamide | US WorldMeds LLC | NULL | Completed | 18 Years | N/A | All | 127 | Phase 4 | United States |
| 194 | NCT03652363 (ClinicalTrials.gov) | October 25, 2012 | 21/8/2018 | GDNF in ideopathicParkinsons Disease | A Placebo-Controlled, Randomised, Double-Blind Trial to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal (GDNF) Infusions Administered Via Convection Enhanced Delivery (CED) in Subjects With Parkinson&Apos;s Disease | Idiopathic Parkinson Disease | Drug: glial cell line-derived neurotrophic factor | North Bristol NHS Trust | NULL | Completed | 35 Years | 75 Years | All | 42 | Phase 2 | NULL |
| 195 | JPRN-UMIN000009099 | 2012/10/01 | 12/10/2012 | The effect of lidocaine injection into the external oblique in Parkinson's disease patients with upper camptorcormia | The effect of lidocaine injection into the external oblique in Parkinson's disease patients with upper camptorcormia - The effect of lidocaine injection in Parkinson's disease patients with camptorcormia | Parkinson's disease | lidocaine injection into the external oblique normal saline injection into the external oblique | Parkinson's disease and Movement Disorder Center | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 10 | Not applicable | Japan |
| 196 | NCT00947037 (ClinicalTrials.gov) | August 2012 | 24/7/2009 | Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension Study | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects | Parkinson's Disease | Drug: AP-CD/LD | Intec Pharma Ltd. | NULL | Withdrawn | 30 Years | 95 Years | Both | 0 | Phase 2 | Israel |
| 197 | NCT02419313 (ClinicalTrials.gov) | August 2012 | 27/1/2014 | Investigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Tremor: A Customized Approach | Investigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Disease Tremor: A Customized Approach | Parkinson;Tremor | Drug: incobotulinumtoxinA;Drug: Saline | Yale University | NULL | Completed | 18 Years | N/A | All | 33 | Phase 2 | United States |
| 198 | JPRN-UMIN000008477 | 2012/07/19 | 19/07/2012 | Clinical study of selegiline hydrochloride ( FP OD tablet 2.5) to flexion of spine in Parkinson's disease. | Clinical study of selegiline hydrochloride ( FP OD tablet 2.5) to flexion of spine in Parkinson's disease. - Clinical study of selegiline to flexion of spine in Parkinson's disease. | Parkinson disease | Selegiline hydrochloride 5mg 8weeks, 7.5mg 8weeks and stop it, followed after 8weeks, and evaluate each points. | Department of Neurology, Juntendo Koshigaya Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 20 | Not selected | Japan |
| 199 | JPRN-UMIN000008138 | 2012/07/01 | 01/07/2012 | Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease | Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease - Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease | Parkinson's disease | Silodosin 8mg BID | Juntendo University School of Medicine | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male | 100 | Not selected | Japan |
| 200 | JPRN-UMIN000008057 | 2012/06/01 | 06/06/2012 | Effect of enteral formula enriched with omega-3 fatty acid to prevention of weight reduction in patients with Parkinson's Disease | Effect of enteral formula enriched with omega-3 fatty acid to prevention of weight reduction in patients with Parkinson's Disease - Effect of enteral formula enriched with omega-3 fatty acid in patients with Parkinson's Disease | Parkinson's Disease | Daily oral administration of enteral nutrition formula (Racol NF) 400ml for 12 weeks consecutively. | St. Mariannna University School of Medicine | NULL | Complete: follow-up complete | 35years-old | 80years-old | Male and Female | 25 | Not applicable | Japan |
| 201 | NCT02786667 (ClinicalTrials.gov) | June 2012 | 18/5/2016 | Non Motors Aspects in De Novo Parkinson's Disease | Non Motors Aspects in De Novo Parkinson's Disease: Clinical and Physiopathological Description; Dopamine Agonist Treatment Effects. | Parkinson Disease;Apathy | Drug: Rotigotine;Drug: Placebo | University Hospital, Grenoble | NULL | Active, not recruiting | 30 Years | 72 Years | All | 199 | Phase 3 | France |
| 202 | JPRN-UMIN000007896 | 2012/05/01 | 07/05/2012 | Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes | Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes - Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes | Parkinson's disease and other parkinsonian syndromes | The patients are given domperidone 30 mg/day for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day lactose powder is given to the patients and levodopa (250 mg)/carbidopa (25 mg) is given on the fifth day in a double-blind manner. On fourth and fifth day, motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug. The patients are given domperidone 30 mg/day (standard dose in Japan) for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day levodopa (250 mg)/carbidopa (25 mg) is given to the patients and lactose powder is given on the fifth day in a double-blind manner. Motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug. | Kansai Medical University | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 100 | Not selected | Japan |
| 203 | NCT01494532 (ClinicalTrials.gov) | April 2, 2012 | 1/12/2011 | A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's Disease | A Fixed Dose, Dose-response Study of Ropinirole Prolonged Release (PR) as Adjunctive Treatment to L-dopa in Patients With Advanced Parkinson's Disease | Parkinson Disease | Drug: ropinirole/L-dopa;Drug: placebo/L-dopa | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 352 | Phase 4 | United States;Argentina;Chile;Estonia;Korea, Republic of;Russian Federation;Slovakia;Poland |
| 204 | NCT01523301 (ClinicalTrials.gov) | April 2012 | 27/1/2012 | Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients | Double Blind, Placebo-controlled, Parallel, Multicenter, Randomized Interventional Phase IV Study to Evaluate the Efficacy of Rotigotine on Depressive Symptoms in Idiopathic Parkinson's Disease Patients | Idiopathic Parkinson's Disease | Drug: Rotigotine;Drug: Placebo | UCB Korea Co., Ltd. | NULL | Completed | 20 Years | N/A | All | 380 | Phase 4 | Korea, Republic of |
| 205 | NCT01331122 (ClinicalTrials.gov) | April 2012 | 13/10/2010 | Study to Assess Droxidopa in the Treatment of Freezing Of Gait Symptoms in Patients With Parkinson's Disease | A Phase II, Double-Blind, Placebo-Controlled Randomized Crossover Study to Assess the Clinical Benefit and Safety of Droxidopa in the Treatment of Freezing of Gait Symptoms in Patients With Parkinson's Disease | Gait Disorders, Neurologic | Drug: droxidopa | Chelsea Therapeutics | NULL | Withdrawn | 30 Years | N/A | Both | 0 | Phase 1/Phase 2 | United States;Canada |
| 206 | NCT01486628 (ClinicalTrials.gov) | April 2012 | 4/12/2011 | Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers | A Phase I, Single Dose, Single-centre, Randomized, Double-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers | Parkinson's Disease | Drug: ND0612;Drug: Placebo | NeuroDerm Ltd. | NULL | Completed | 18 Years | 40 Years | Male | 36 | Phase 1 | Israel |
| 207 | NCT01527695 (ClinicalTrials.gov) | April 2012 | 22/12/2011 | PET Study in Parkinson's Disease Patients | A Phase IIA, Multi Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment With Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients With Parkinson's Disease | Parkinson's Disease | Drug: ER tablet 25 mg AZD3241;Drug: ER tablet 100 mg AZD3241;Drug: Placebo for AZD3241 25 mg;Drug: Placebo for AZD3241 100 mg | AstraZeneca | NULL | Completed | 45 Years | 75 Years | Both | 24 | Phase 2 | Sweden |
| 208 | NCT01491529 (ClinicalTrials.gov) | April 2012 | 12/12/2011 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of Modified Release AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease | Dyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders;Anti-Dyskinesia Agents | Drug: AFQ056;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 30 Years | 80 Years | All | 154 | Phase 2 | United States;Austria;Canada;France;Germany;Hungary;Italy;Slovakia;Spain;Switzerland;Turkey |
| 209 | NCT01556165 (ClinicalTrials.gov) | April 2012 | 13/3/2012 | Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China | Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China | Parkinson's Disease | Drug: rasagiline;Drug: placebo | H. Lundbeck A/S | NULL | Completed | 35 Years | N/A | All | 130 | Phase 3 | China |
| 210 | NCT01550484 (ClinicalTrials.gov) | April 2012 | 6/3/2012 | A Trial of 18F-AV-133 Positron Emission Tomography (PET) Imaging to Differentiate Subjects With Parkinson's Disease (PD) From Other Movement Disorders | An Open Label, Multicenter Study, Evaluating the Safety and Efficacy of 18F-AV-133 PET Imaging to Identify Subjects With Dopaminergic Degeneration Among Subjects Presenting to a Movement Disorders Specialty Clinic With an Uncertain Diagnosis | Parkinson's Disease;Primary Parkinsonism;Lewy Body Parkinson's Disease | Drug: 18F-AV-133 | Avid Radiopharmaceuticals | NULL | Completed | 40 Years | N/A | All | 170 | Phase 2/Phase 3 | United States;Australia |
| 211 | EUCTR2011-002901-31-DE (EUCTR) | 08/03/2012 | 06/10/2011 | not applicable | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Hungary;Czech Republic;Spain;Germany;United Kingdom | |||
| 212 | EUCTR2011-002901-31-HU (EUCTR) | 21/12/2011 | 13/10/2011 | not applicable | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Czech Republic;Hungary;Spain;Germany;United Kingdom | |||
| 213 | EUCTR2011-002901-31-CZ (EUCTR) | 12/12/2011 | 10/10/2011 | not applicable | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODONE HYDROCHLORIDE Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: NAL | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Hungary;Czech Republic;Spain;Germany;United Kingdom | |||
| 214 | EUCTR2011-002901-31-ES (EUCTR) | 30/11/2011 | 05/10/2011 | not applicable | A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson?s disease associated pain | Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain. MedDRA version: 14.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg Product Code: OXN 5 mg/2.5 mg PR INN or Proposed INN: Oxycodone hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 10 mg/5 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg Product Code: OXN 10 mg / 5 mg PR INN or Proposed INN: Oxycodone Hydrochloride Other descriptive name: OXYCODONE HYDROCHLORIDE INN or Proposed INN: Naloxone Hydrochloride Dihydrate Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE Trade Name: Targinact 20 mg/10 mg prolonged-release tablets Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg Product Code: OXN 20 mg / 10 mg PR INN or Proposed INN: OXYCODO | Mundipharma Research GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | Hungary;Czech Republic;Spain;Germany;United Kingdom | ||
| 215 | JPRN-UMIN000006521 | 2011/10/01 | 11/10/2011 | Switch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's disease | Switch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's disease - Switch trial from IR to ER of Pramipexole | Parkinson's disease | Rapid switch of Pramipexole ER (once in a day) which is same dose as IR. The period of administration is 8 weeks. | Department of Neurology, Juntendo University | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 216 | EUCTR2010-020299-42-DE (EUCTR) | 30/08/2011 | 26/04/2011 | A study in U.S. and Germany to show if patients with an early stage of Parkinson's disease could be treated with a nicotine patch. In this study the nicotine patch is being compared to a placebo patch. The placebo patch is identical in appearance to the nicotine patch but does not contain any active ingredients. | A randomized, placebo-controlled, double-blind, multi-center trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA (NIC-PD) - NIC-PD | Early PD subjects within 18 months of diagnosis and not expected to require dopamine agonist or levodopa therapy for 1 year, with Hoehn and Yahr stage <2, with stable (>2 months) MAO-B inhibitor therapy allowed MedDRA version: 16.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Nicotinell 17,5 mg/24-Stunden-Pflaster Product Name: Nicotinell Other descriptive name: NICOTINE Trade Name: Nicotinell 35 mg/24-Stunden-Pflaster Product Name: Nicotinell Other descriptive name: NICOTINE | Philipps-University Marburg | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Germany | ||
| 217 | NCT01504178 (ClinicalTrials.gov) | May 2011 | 30/12/2011 | Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's Disease | Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's Disease | Parkinson's Disease | Drug: duloxetine;Drug: placebo of duloxetine;Drug: injection of apomorphine;Drug: injection of placebo of apomorphine;Drug: L-Dopa;Drug: injection of placebo of L-Dopa | University Hospital, Toulouse | French Parkinson Association | Completed | 30 Years | 70 Years | All | 28 | Phase 3 | France |
| 218 | NCT01338896 (ClinicalTrials.gov) | April 2011 | 18/4/2011 | Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations | A Multicenter, Randomized, Double-blind, Two-way Cross-over Study to Compare the Adhesiveness of Two Different Rotigotine Patch Formulations in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: Rotigotine transdermal patch | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | 56 | Phase 1 | Austria;Germany;United Kingdom |
| 219 | NCT01336088 (ClinicalTrials.gov) | April 2011 | 4/4/2011 | ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease | Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of ADX48621 in the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease | Parkinson's Disease | Drug: ADX48621;Drug: Placebo | Addex Pharma S.A. | NULL | Completed | 30 Years | 75 Years | Both | 83 | Phase 2 | United States;Austria;France;Germany |
| 220 | NCT01313819 (ClinicalTrials.gov) | April 2011 | 10/3/2011 | The Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy | A Double Blind, Placebo-controlled Study for the Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy | Parkinson`s Disease;Freezing of Gait | Drug: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj | Seoul National University Hospital | NULL | Recruiting | 30 Years | 80 Years | Both | 20 | Phase 4 | Korea, Republic of |
| 221 | NCT01662414 (ClinicalTrials.gov) | April 2011 | 7/8/2012 | Effect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's Disease | Effect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's Disease: Changes in Biomarkers of Oxidative Stress, Profiles of Plasma Amino Acids and Their Derivatives and Brain Function | Parkinson Disease;Parkinsonian Disorders;Basal Ganglia Diseases;Brain Diseases;Central Nervous System Diseases;Nervous System Diseases;Movement Disorders;Neurodegenerative Diseases | Dietary Supplement: Whey protein;Dietary Supplement: Soy protein | Chulalongkorn University | NULL | Completed | 30 Years | 80 Years | Both | 38 | Phase 4 | Thailand |
| 222 | NCT01937078 (ClinicalTrials.gov) | April 2011 | 26/7/2012 | Famotidine for Levodopa-induced Dyskinesia in PD | An 'N-of-1' Study of the Histamine H@ Antagonist, Famotidine in Levodopa-induced Dyskinesia in Parkinson's Disease | Dyskinesia | Drug: Famotidine | University Health Network, Toronto | NULL | Completed | 18 Years | 80 Years | Both | 7 | Phase 2 | Canada |
| 223 | NCT02880033 (ClinicalTrials.gov) | February 2011 | 3/8/2016 | Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes | Modulation of Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes of Patients With Parkinson's Disease or Amyotrophic Lateral Sclerosis | Parkinson's Disease;Amyotrophic Lateral Sclerosis;Oxidative Stress;Iron Overload | Drug: deferiprone;Drug: placebo | University Hospital, Lille | NULL | Completed | 18 Years | 80 Years | All | 90 | N/A | France |
| 224 | EUCTR2010-018650-12-FR (EUCTR) | 13/07/2010 | 06/05/2010 | Evaluation du système noradrénergique dans l’altération de la perception douloureuse chez le patient Parkinsonien - DOULOX | Evaluation du système noradrénergique dans l’altération de la perception douloureuse chez le patient Parkinsonien - DOULOX | maladie de Parkinson MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: CYMBALTA Product Name: duloxetine Trade Name: APOKINON Product Name: apomorphine Trade Name: MODOPAR Product Name: levodopa Trade Name: MOTILIUM Product Name: dompéridone | CHU de Toulouse | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | France | |||
| 225 | NCT01113320 (ClinicalTrials.gov) | April 2010 | 8/4/2010 | Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease Subjects | A Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose Escalation Trial to Explore the Potential Antidyskinetic Properties of Safinamide in Patients With Parkinson's Disease Suffering From Levodopa Induced Dyskinesias | Parkinson's Disease | Drug: Placebo;Drug: Safinamide | Newron | NULL | Completed | 30 Years | N/A | Both | 26 | Phase 2 | Austria;Canada;France;Germany;South Africa |
| 226 | NCT01103011 (ClinicalTrials.gov) | April 2010 | 12/4/2010 | Safety, Tolerability and Pharmacokinetic Profile of Levodopa Administered With Continuous Administration of ND0611 | A Phase I, Single Center, Blinded, Controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Repeated Administration of Oral Levodopa/Carbidopa and Continuously Delivered ND0611 | Parkinson's Disease | Drug: ND0611 | NeuroDerm Ltd. | NULL | Completed | 18 Years | 50 Years | Male | 8 | Phase 1 | Israel |
| 227 | NCT01484990 (ClinicalTrials.gov) | April 2010 | 28/7/2011 | A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease | A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease | Parkinson Disease | Drug: Levodopa-Carbidopa | AbbVie | Quintiles, Inc. | Completed | 30 Years | 99 Years | All | 19 | Phase 1 | Germany;Sweden |
| 228 | NCT00988117 (ClinicalTrials.gov) | April 2010 | 29/9/2009 | The Effects of the Rivastigmine Patch on Parkinson's Disease With Memory and/or Thinking Problems | The Effects of the Rivastigmine Patch on Attention and Behavior in Parkinson's Disease With Dementia (PDD) | Parkinsons Disease With Dementia;Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems | Drug: Rivastigmine Patch 9.5 cm2 | University of California, San Francisco | Novartis | Completed | 55 Years | N/A | All | 15 | Phase 4 | United States |
| 229 | EUCTR2009-017416-33-DE (EUCTR) | 18/01/2010 | 21/12/2009 | Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol. | Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol. | Male and female patients with Parkinson´s disease meeting UKPDS criteria MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Tasmar Product Name: Tolcapon Product Code: TO INN or Proposed INN: TOLCAPONE Trade Name: Comtess Product Name: Entacapon Product Code: EN INN or Proposed INN: ENTACAPONE Trade Name: Isicom Product Name: Levodopa/Carbidopa Product Code: LD/CD INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE Trade Name: Tasmar Product Name: Tolcapon Product Code: TO INN or Proposed INN: TOLCAPONE Trade Name: Comtess Product Name: Entacapon Product Code: EN INN or Proposed INN: ENTACAPONE Trade Name: Isicom Product Name: Levodopa/Carbidopa Product Code: LD/CD INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE | Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-University | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 230 | EUCTR2009-012643-42-NL (EUCTR) | 06/01/2010 | 30/11/2009 | Freezing of gait in Parkinson's disease: in search of the underlying mechanism and the application of a new treatment option - Freezing of gait in Parkinson's disease | Freezing of gait in Parkinson's disease: in search of the underlying mechanism and the application of a new treatment option - Freezing of gait in Parkinson's disease | Parkinson's disease, in particular the symptom Freezing of Gait | Trade Name: Ritalin Product Name: Not applicable Product Code: Not applicable INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE Other descriptive name: Ritalin | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 231 | JPRN-UMIN000003080 | 2010/01/01 | 30/01/2010 | Double Blind Study for Effects of Donepezil Hydrochloride on Parkinson's Disease | Double Blind Study for Effects of Donepezil Hydrochloride on Parkinson's Disease - EDP2010 study | Parkinson's disease | Donepezil hydrochloride (3mg for 2 weeks, 5mg for 2 weeks) Placebo | Clinical Research Center, Utano National Hospital, National Hospital Organization | NULL | Complete: follow-up complete | 40years-old | 75years-old | Male and Female | 30 | Not applicable | Japan |
| 232 | JPRN-UMIN000007497 | 2010/01/01 | 14/03/2012 | Trial of molecular hydrogen water in Parkinson disease | Trial of molecular hydrogen water in Parkinson disease - Randomized Double-blind, Placebo-controlled trial on molecular hydrogen water in Parkinson Disease | Parkinson disease | The subjects should make 1000 ml of molecular hydrogen water which contains 1.6 ppm dissolved hydrogen by Aquerable, and consume for 48 weeks. Placebo water which is not contained molecular hydrogen water made from pseudo-machine. The subjects consume for48 weeks. | Department of Neurology, Juntendo University School of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 18 | Not applicable | Japan |
| 233 | NCT00918177 (ClinicalTrials.gov) | July 2009 | 1/6/2009 | An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's Disease | Dual Release Gastric Retentive AP09004, Vs. Active Control; a Pharmacokinetic/Pharmacodynamic, Comparative, Safety Evaluation in Parkinson's Patients | Parkinson's Disease | Drug: AP09004;Drug: Carbidopa/Levodopa, immediate release | Intec Pharma Ltd. | NULL | Completed | 18 Years | N/A | Both | 72 | Phase 2 | Israel |
| 234 | NCT00845000 (ClinicalTrials.gov) | April 21, 2009 | 13/2/2009 | Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550) | Acute Effects of SCH 420814 on Dyskinesia and Parkinsonism in Levodopa Treated Patients | Parkinson Disease | Drug: SCH 420814 10 mg;Drug: SCH 420814 100 mg;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa | Merck Sharp & Dohme Corp. | Oregon Health and Science University | Completed | 18 Years | N/A | All | 12 | Phase 1 | United States |
| 235 | JPRN-JapicCTI-090888 | 01/4/2009 | A Double-Blind, 3-Arm, Parallel Group, Placebo-and Ropinirole-Controlled Study of SPM 962 in Subjects with Parkinson's Disease Treated Concomitantly with L-dopa | A Double-Blind, 3-Arm, Parallel Group, Placebo-and Ropinirole-Controlled Study of SPM 962 in Subjects with Parkinson's Disease Treated Concomitantly with L-dopa | Parkinson's Disease Treated Concomitantly with L-dopa | Intervention name : SPM 962 Dosage And administration of the intervention : SPM 962: transdermal application, 1 time per day. Initial dose:4.5mg/day, weekly increment of 4.5mg/day, maximal maintenance dose : 36.0mg/day. Placebo of ropinirole: oral application 3 times per day. Initial dose:0.75mg placebo/day, weekly increment of 0.75mg placebo/day (up to 3.0mg placebo/day), then 1.5mg placebo/day (up to 15.0mg placebo/day), maximal maintenance dose 15.0 mg placebo/day Control intervention name : Ropinirole Dosage And administration of the control intervention : placebo SPM 962: transdermal application, 1 time per day. Initial dose: 4.5mg placebo/day, weekly increment of 4.5mg placebo/day, maximal maintenance dose : 36.0mg placebo/day. Ropinirole: oral application 3 times per day. Initial dose:0.75mg/day, weekly increment of 0.75mg/day (up to 3.0mg/day), then 1.5mg/day (up to 15.0mg/day), maximal maintenance dose 15.0 mg/day. Control intervention name : Placebo Dosage And administration of the control intervention : placebo SPM 962: transermal application, 1 time per day. Initial dose: 4.5mg placebo/day, weekly increment of 4.5mg placebo/day, maximal maintenance dose : 36.0mg placebo/day. Placebo ropinirole: oral application 3 times per day. Initial dose:0.75mg placebo/day, weekly increment of 0.75mg placebo/day (up to 3.0mg placebo/day), then 1.5mg placebo/day (up to 15.0mg placebo/day), maximal maintenance dose 15.0 mg placebo/day. | Otsuka Pharmaceutical Co., Ltd. | NULL | 30 | 79 | BOTH | 400 | Phase 3 | NULL | ||
| 236 | NCT00865579 (ClinicalTrials.gov) | April 2009 | 10/3/2009 | Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients | Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients | Parkinson's Disease | Drug: Safinamide | Newron | NULL | Terminated | 30 Years | N/A | All | 964 | Phase 3 | Romania |
| 237 | NCT01568034 (ClinicalTrials.gov) | April 2009 | 29/3/2012 | A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 | A Double-blind, Randomised, Placebo-controlled, Cross-over Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 on the Levodopa Pharmacokinetics, Motor Response, and Erythrocyte Soluble Catechol-O-methyltransferase Activity in Parkinson's Disease Patients Concomitantly Treated With Levodopa/Dopa-decarboxylase Inhibitor | Parkinson's Disease | Drug: BIA 9-1067;Drug: Placebo;Drug: Levodopa/Carbidopa;Drug: Levodopa/Benzerazide | Bial - Portela C S.A. | NULL | Completed | 30 Years | 75 Years | All | 10 | Phase 2 | Portugal;Romania;Ukraine |
| 238 | NCT00914134 (ClinicalTrials.gov) | April 2009 | 1/6/2009 | Duodenal Levodopa Infusion, Quality of Life and Autonomic Nervous System in Parkinson's Disease | Effect of Duodenal Levodopa Infusion on Quality of Life and Autonomic Dysfunction in Patients With Parkinson's Disease | Parkinson's Disease | Drug: Levodopa infusion | Helsinki University | Solvay Pharmaceuticals | Completed | 40 Years | 80 Years | Both | 12 | Phase 4 | Finland |
| 239 | NCT00880620 (ClinicalTrials.gov) | April 2009 | 3/4/2009 | A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease | A Placebo-Controlled Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease | Parkinson's Disease | Drug: Placebo;Drug: IPX066 95 mg LD;Drug: IPX066 145 mg LD;Drug: IPX066 195 mg LD;Drug: IPX066 245 mg LD | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 381 | Phase 3 | United States;Canada;Estonia;Latvia;Lithuania;Romania;Ukraine |
| 240 | NCT00875316 (ClinicalTrials.gov) | April 2009 | 2/4/2009 | Safety and Tolerability Study of Cogane™ in Healthy Volunteers and Parkinson's Disease Patients | A Randomised, Double-blind, Multiple Dose-ascending, Placebo-controlled Study in Healthy Volunteers and Parkinson's Disease Patients to Assess the Safety, Tolerability and PK of Daily Oral Administration of Cogane™ Over One Month | Parkinson's Disease | Drug: Cogane™ (PYM50028) | Phytopharm | NULL | Completed | 40 Years | 80 Years | Both | 36 | Phase 1 | United Kingdom |
| 241 | EUCTR2008-004447-11-GB (EUCTR) | 27/03/2009 | 07/01/2009 | A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease | A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease | Unpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease MedDRA version: 11;Level: LLT;Classification code 10067209;Term: | Product Name: Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride | Vectura Limited | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | Germany;United Kingdom;Italy | ||
| 242 | NCT00758368 (ClinicalTrials.gov) | March 2009 | 23/9/2008 | Comparison of Continuous and Pulsatile Apomorphine in Parkinson's Disease | Comparison of Continuous and Pulsatile Apomorphine Administration in Parkinson's Disease Complicated by Levodopa-induced Dyskinesia | Parkinson's Disease | Drug: Apomorphine | Oregon Health and Science University | National Institute of Neurological Disorders and Stroke (NINDS) | Withdrawn | 21 Years | N/A | All | 0 | Phase 2 | United States |
| 243 | NCT00767091 (ClinicalTrials.gov) | March 2009 | 1/9/2008 | Study of Rivastigmine to Treat Parkinsonian Apathy Without Dementia | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicentric Trial | Parkinson's Disease;Apathy;no Dementia | Drug: rivastigmine;Drug: placebo | University Hospital, Lille | NULL | Completed | 15 Years | 80 Years | Both | 40 | Phase 3 | France |
| 244 | EUCTR2008-006045-10-FR (EUCTR) | 06/02/2009 | 24/03/2009 | Effet de la stimulation dopaminergique continue par pompe à apomorphine sur les fluctuations cognitives et psychiques des patients parkinsoniens: étude clinique et métabolique cérébrale par TEP au 18FDG - APO TEP | Effet de la stimulation dopaminergique continue par pompe à apomorphine sur les fluctuations cognitives et psychiques des patients parkinsoniens: étude clinique et métabolique cérébrale par TEP au 18FDG - APO TEP | L’objectif thérapeutique principal dans la maladie de Parkinson est de contrôler les fluctuations motrices. Cependant des fluctuations non motrices (FNM) sont fréquemment observées et semblent corrélées à la sévérité de la maladie. La stabilité dans le temps de l’efficacité du traitement dopaminergique est le moyen le plus pertinent pour améliorer les fluctuations tant motrices que non motrices. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Apokinon | CHU de Rennes | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 245 | NCT01039090 (ClinicalTrials.gov) | February 2009 | 22/12/2009 | Efficacy of Continuous Apomorphine Infusion on Cognitive and Neuropsychological Functions in Parkinson's Disease | Prospective, Randomised, Comparative Study Comparing Efficacy of Continuous Apomorphine Infusion Versus Usual Dopaminergic Per os Treatment on Cognitive and Neuropsychological Functions in Parkinson's Disease: a Clinical and PET-scan Study | Parkinsons's Disease | Drug: Continuous Apomorphine infusion;Drug: Usual dopaminergic per os treatment | Rennes University Hospital | NULL | Completed | 18 Years | N/A | All | 21 | Phase 3 | France |
| 246 | NCT00809302 (ClinicalTrials.gov) | December 2008 | 15/12/2008 | Efficacy and Safety Study of Aplindore in Patients With Early Parkinson Disease | A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Doses of Aplindore MR (1, 3, and 6 mg Twice Daily) in Patients With Early Parkinson Disease (APLIED) | Early Parkinson Disease | Drug: aplindore MR tablets or Placebo | Neurogen Corporation | NULL | Terminated | 30 Years | N/A | Both | 9 | Phase 2 | United States |
| 247 | NCT00755027 (ClinicalTrials.gov) | September 2008 | 17/9/2008 | Rasagiline and Apathy in Parkinson's Disease | A Randomised Placebo-controlled Trial of Rasagiline in Parkinson Disease Patients With Symptoms of Apathy | Parkinson's Disease | Drug: Rasagiline | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | NULL | Completed | 18 Years | 80 Years | Both | 40 | Phase 4 | Spain |
| 248 | EUCTR2008-001336-13-FR (EUCTR) | 16/07/2008 | 09/06/2008 | Effet de la Nicotine transdermique sur les symptomes moteurs de la maladie de Parkinson avancée (une administration quotidienne) .Etude contrôlée, randomisée, en deux groupes parallèles et en simple insu sur 40 patients. - NICOPARK2 | Effet de la Nicotine transdermique sur les symptomes moteurs de la maladie de Parkinson avancée (une administration quotidienne) .Etude contrôlée, randomisée, en deux groupes parallèles et en simple insu sur 40 patients. - NICOPARK2 | Maladie Parkinson MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Nicorette 5 mg/ 16 h Product Name: Nicorette 5 mg/ 16 h INN or Proposed INN: Nicotine Product Name: Nicorette 10mg/ 16 h INN or Proposed INN: Nicotine Product Name: Nicorette 15 mg/ 16 h INN or Proposed INN: Nicotine | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 249 | NCT00605553 (ClinicalTrials.gov) | April 2008 | 15/1/2008 | Study to Evaluate SYN115 in Parkinson's Disease | A Randomized, Double-blind, Placebo Controlled, Two-way Cross-over Study to Explore the Effects of 7 Days of Dosing With SYN115 20 mg p.o. BID or 60 mg p.o. BID on Clinical and fMRI Response to Intravenous Levodopa in Patients With Mild to Moderate Parkinson's Disease | Parkinson's Disease | Drug: Placebo;Drug: Tozadenant | Biotie Therapies Inc. | NULL | Completed | 40 Years | 75 Years | All | 30 | Phase 2 | United States |
| 250 | NCT00651183 (ClinicalTrials.gov) | April 2008 | 31/3/2008 | Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment | Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment | Parkinson Disease | Drug: Pramipexole immediate release | Boehringer Ingelheim | NULL | Completed | 18 Years | N/A | All | 286 | Austria | |
| 251 | NCT00753636 (ClinicalTrials.gov) | April 2008 | 13/9/2008 | Parkinson's Disease Isradipine Safety Study | Phase II Safety and Tolerability of Isradipine (A Potential Neuroprotective Agent) in Patients With Parkinson's Disease- Stage II | Parkinson's Disease | Drug: Dynacirc CR (Isradipine) | Northwestern University | Northwestern Memorial Hospital | Completed | 30 Years | 75 Years | All | 31 | Phase 2 | United States |
| 252 | NCT02071810 (ClinicalTrials.gov) | April 2008 | 19/1/2012 | Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067 | A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Four Multiple Rising Dose Regimens of BIA 9-1067 in Healthy Male Volunteers | Parkinson's Disease (PD) | Drug: BIA 9-1067;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Male | 34 | Phase 1 | France |
| 253 | NCT00623324 (ClinicalTrials.gov) | January 2008 | 14/2/2008 | The Effects of Aplindore on the Treatment of Signs and Symptoms of Parkinson's Disease | A Phase II, Dose Ranging, Randomized, Double Blind, Placebo-controlled, Multi-center, Pilot Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of Aplindore in Patients With Early Stage Parkinson's Disease | Early Stage Parkinson's Disease | Drug: Aplindore;Drug: Placebo | Ligand Pharmaceuticals | NULL | Completed | 30 Years | N/A | Both | 40 | Phase 2 | United States |
| 254 | EUCTR2007-004400-12-ES (EUCTR) | 27/12/2007 | 03/01/2008 | ENSAYO RANDOMIZADO A DOBLE CIEGO Y CONTROLADO CON PLACEBO DE RASAGILINA EN PACIENTES CON ENFERMEDAD DE PARKINSON Y SINTOMAS DE APATIA - Rasagiline and Apathy | ENSAYO RANDOMIZADO A DOBLE CIEGO Y CONTROLADO CON PLACEBO DE RASAGILINA EN PACIENTES CON ENFERMEDAD DE PARKINSON Y SINTOMAS DE APATIA - Rasagiline and Apathy | Apatía en la Enfermedad de Parkinson MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Azilect INN or Proposed INN: RASAGILINE | Institut de Recerca de l'Hospital de la santa Creu i Sant Pau | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Spain | ||||
| 255 | NCT00610103 (ClinicalTrials.gov) | November 2007 | 22/1/2008 | Phase 2 Clinical Study of KW-6500 in Parkinson's Disease Patients With Motor Response Complication on Levodopa Therapy | A Phase 2 Clinical Study of KW-6500 (Apomorphine Hydrochloride) in Patients With Parkinson's Disease | Parkinson's Disease | Drug: apomorphine hydrochloride | Kyowa Kirin Co., Ltd. | NULL | Completed | 20 Years | N/A | All | 16 | Phase 2 | Japan |
| 256 | EUCTR2005-005791-32-SE (EUCTR) | 04/10/2007 | 30/07/2007 | Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease. | Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease. | HF0220 experimentally appears to exert its potential beneficial effects within the CNS and possibly other tissues by attenuating the adverse effects of oxidative stress. It is believed that this mechanism has the potential to reduce disease progression in a wide range of disorders of the nervous system, e.g. Alzheimer's and Parkinson's disease, and brain damage due to acute stroke and head injury. It may also apply to the protection of peripheral tissues, such as the heart and/or kidney. MedDRA version: 9.1;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes) | Product Name: HF0220 Product Code: HF0220 Other descriptive name: 7-beta-hydroxyepiandrosterone | Hunter-Fleming Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | United Kingdom;Sweden | |||
| 257 | NCT00524914 (ClinicalTrials.gov) | September 2007 | 4/9/2007 | Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study | Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study. | Parkinson's Disease | Drug: apomorphine;Drug: placebo | University Hospital, Toulouse | NULL | Completed | 30 Years | 70 Years | Both | 16 | N/A | France |
| 258 | EUCTR2006-005318-11-FR (EUCTR) | 06/07/2007 | 10/05/2007 | Effet de l'apomorphine sur la perception douloureuse chez le patient parkinsonien : étude clinique et en tomographie par émission de positons. | Effet de l'apomorphine sur la perception douloureuse chez le patient parkinsonien : étude clinique et en tomographie par émission de positons. | maladie de Parkinson MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: APOKINON | CHU Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 259 | JPRN-UMIN000000780 | 2007/06/01 | 01/08/2007 | A randomized, double-blind, placebo-controlled, cross-over, multi-center study concerning the efficacy and safety of amantadine hydrochloride in treatment of dyskinesias in Parkinson's disease | A randomized, double-blind, placebo-controlled, cross-over, multi-center study concerning the efficacy and safety of amantadine hydrochloride in treatment of dyskinesias in Parkinson's disease - The usefulness of amantadine hydrochloride in treatment of dyskinesias in Parkinson's disease | Parkinson's disease | An observation period (2 to 3 weeks) An administration of amantadine hydrochloride (27 days) A wash out period (15 days) An administration of placebo (27 days) An observation period (2 to 3 weeks) An administration of placebo (27 days) A wash out period (15 days) An administration of amantadine hydrochloride (27 days) | Comprehensive clinical study group concerning diagnosis, treatment, and prevention of the neurological disorders | Musashi Hospital, National Center of Neurology and Psychiatry, JapanEhime University Hospital | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 60 | Not applicable | Japan |
| 260 | NCT00489255 (ClinicalTrials.gov) | May 2007 | 20/6/2007 | Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment | A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Trimethobenzamide (Tigan®) in the Control of Nausea and Vomiting During Initiation and Continued Treatment With Subcutaneous Apomorphine (Apokyn®) in Apomorphine-naïve Subjects With Parkinson's Disease Suffering From Acute Intermittent Off Episodes, With Phased Withdrawal of Subjects From Tigan® to Placebo | Parkinson's Disease | Drug: Tigan®;Drug: Placebo | Ipsen | INC Research Limited | Completed | 18 Years | N/A | All | 117 | Phase 4 | United States |
| 261 | NCT00434304 (ClinicalTrials.gov) | April 9, 2007 | 9/2/2007 | Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD) | Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease - an Open-Label, Uncontrolled Study - | Parkinson Disease | Drug: Ropinirole prolonged release/extended release(PR/XR) | GlaxoSmithKline | NULL | Completed | 20 Years | N/A | All | 62 | Phase 2 | Japan |
| 262 | NCT00460148 (ClinicalTrials.gov) | April 2007 | 11/4/2007 | Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole | An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. | Parkinson Disease | Drug: Ropinirole | GlaxoSmithKline | NULL | Completed | 30 Years | 85 Years | Both | 28 | Phase 2 | Germany;South Africa |
| 263 | NCT00623363 (ClinicalTrials.gov) | April 2007 | 2/1/2008 | Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease | Parkinson's Disease | Drug: piclozotan;Drug: 0.9% sodium chloride (normal saline) | Asubio Pharmaceuticals, Inc. | NULL | Completed | 40 Years | 85 Years | Both | 27 | Phase 2 | United States;Guatemala;Romania | |
| 264 | NCT00459420 (ClinicalTrials.gov) | April 2007 | 11/4/2007 | Caffeine for Excessive Daytime Somnolence in Parkinson's Disease | Caffeine for Excessive Daytime Somnolence in Parkinson's Disease | Parkinson's Disease;Excessive Daytime Somnolence | Drug: Caffeine 100-200 mg BID;Drug: placebo | Ron Postuma | Canadian Institutes of Health Research (CIHR);University of Toronto | Completed | 18 Years | N/A | Both | 58 | Phase 2/Phase 3 | Canada |
| 265 | NCT00466167 (ClinicalTrials.gov) | April 2007 | 25/4/2007 | Pivotal Study in Advanced Parkinsons Disease Patients | A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER) Versus Placebo and Versus Pramipexole Immediate Release (IR) Administered Orally Over a 26-week Maintenance Phase in L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD). | Parkinson Disease | Drug: Pramipexol Extended Release;Drug: Pramipexol Immediate Release;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 32 Years | N/A | All | 517 | Phase 3 | Austria;Czech Republic;Hungary;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Slovakia;Spain;Sweden;Ukraine;United Kingdom |
| 266 | NCT00438607 (ClinicalTrials.gov) | April 2007 | 20/2/2007 | Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Single and Multiple Oral Dose Administration of BIIB014 in Subjects With Moderate to Late Stage Parkinson's Disease Who Are Also Receiving Treatment With Levodopa | Parkinson's Disease | Drug: BIIB014;Drug: Placebo | Biogen Idec | NULL | Completed | 30 Years | N/A | Both | 83 | Phase 2 | India;Israel;United Kingdom |
| 267 | EUCTR2006-005509-79-GB (EUCTR) | 21/12/2006 | 07/12/2006 | A Clinic-Based, Phase IIa, Randomised, Double-Blind, Placebo-Controlled, Ascending-Dose, Multicentre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040 in Patients with Established Idiopathic Parkinson’s Disease | A Clinic-Based, Phase IIa, Randomised, Double-Blind, Placebo-Controlled, Ascending-Dose, Multicentre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040 in Patients with Established Idiopathic Parkinson’s Disease | Idiopathic Parkinson's Disease patients who have motor fluctuations with recognisable motor off” periods | Product Name: apomorphine hydrochloride Product Code: VR040 INN or Proposed INN: apomorphine hydrochloride | Vectura Group plc | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | United Kingdom | ||
| 268 | EUCTR2006-002339-26-IT (EUCTR) | 16/12/2006 | 05/06/2007 | Studio di Estensione Multi-centrico, in Aperto per Valutare Sicurezza, Tollerabilita' ed Efficacia a Lungo Termine di E2007 come Terapia Aggiuntiva in Pazienti affetti da Morbo di Parkinson con Fluttuazioni Motorie Trattati con Levodopa. - E2007-G000-303 | Studio di Estensione Multi-centrico, in Aperto per Valutare Sicurezza, Tollerabilita' ed Efficacia a Lungo Termine di E2007 come Terapia Aggiuntiva in Pazienti affetti da Morbo di Parkinson con Fluttuazioni Motorie Trattati con Levodopa. - E2007-G000-303 | Levodopa treated Parkinson's Disease Patients with Motor Fluctuations MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: E2007 | EISAI LTD UK | NULL | Not Recruiting | Female: yes Male: yes | 1400 | Phase 3 | Portugal;Hungary;Czech Republic;Estonia;Spain;Belgium;Lithuania;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 269 | EUCTR2006-004582-33-GB (EUCTR) | 03/11/2006 | 23/01/2012 | A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalating Study Investigating the Efficacy and Safety of VR040 in the Treatment of Unpredictable Off” or End-of-Dose Wearing Off” Episodes in Patients With Advanced Idiopathic Parkinson’s Disease | A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalating Study Investigating the Efficacy and Safety of VR040 in the Treatment of Unpredictable Off” or End-of-Dose Wearing Off” Episodes in Patients With Advanced Idiopathic Parkinson’s Disease | Hypomobility (off or freezing) episodes associated with advanced Parkinson's disease | Product Name: Apomorphine hydrochloride Product Code: VR040 | Vectura Group plc | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | United Kingdom | ||
| 270 | EUCTR2005-001006-12-CZ (EUCTR) | 06/09/2006 | 24/08/2006 | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment. MedDRA version: 9.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated | Product Name: Lisparin INN or Proposed INN: Lisuride Hydrogenmaleate Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- erg | Axxonis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2;Phase 3 | Czech Republic;Austria;Germany;Italy | ||
| 271 | EUCTR2006-000391-32-NL (EUCTR) | 18/07/2006 | 10/05/2006 | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Apomorphine Nasal Powder Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | Germany;Netherlands;United Kingdom | ||
| 272 | EUCTR2006-000391-32-DE (EUCTR) | 04/07/2006 | 27/04/2006 | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease | Product Name: Apomorphine Nasal Powder Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 130 | United Kingdom;Germany;Netherlands | |||
| 273 | NCT00408915 (ClinicalTrials.gov) | July 2006 | 5/12/2006 | Continuous Application of Lisuride in Parkinson's Disease by Subcutaneous Infusion | Double-blind, Placebo-controlled, Randomized, Multicentre Phase II/III Study to Evaluate the Efficacy and Safety of Lisuride, Applied Subcutaneously by Means of a Minipump in Patients With Advanced Parkinson's Disease Refractory to Conventional Oral Therapy | Parkinson's Disease | Drug: Continuous Subcutaneous Lisuride Infusion | Axxonis Pharma AG | NULL | Completed | 18 Years | 75 Years | Both | 60 | Phase 3 | Germany |
| 274 | NCT00346827 (ClinicalTrials.gov) | July 2006 | 29/6/2006 | Apomorphine Nasal Powder in the Treatment of Parkinson's Disease Off Periods. | Parkinson's Disease | Drug: Apomorphine Nasal Powder | Britannia Pharmaceuticals Ltd. | NULL | Completed | 18 Years | 85 Years | All | 36 | Phase 2/Phase 3 | NULL | |
| 275 | EUCTR2006-000391-32-GB (EUCTR) | 06/06/2006 | 21/04/2006 | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease | Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Apomorphine Nasal Powder Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate | Britannia Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | Netherlands;Germany;United Kingdom | ||
| 276 | NCT03094156 (ClinicalTrials.gov) | April 26, 2006 | 23/3/2017 | Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics | A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study in Healthy Volunteers to Investigate the Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Entacapone 200 mg | Parkinson Disease | Drug: Placebo;Drug: BIA 6-512;Drug: Madopar® 250;Drug: Comtan® | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 39 | Phase 1 | Portugal |
| 277 | EUCTR2005-005791-32-GB (EUCTR) | 24/04/2006 | 17/02/2006 | Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease. | Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease. | HF0220 experimentally appears to exert its potential beneficial effects within the CNS and possibly other tissues by attenuating the adverse effects of oxidative stress. It is believed that this mechanism has the potential to reduce disease progression in a wide range of disorders of the nervous system, e.g. Alzheimer's and Parkinson's disease, and brain damage due to acute stroke and head injury. It may also apply to the protection of peripheral tissues, such as the heart and/or kidney. MedDRA version: 9.1;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes) | Product Name: HF0220 Product Code: HF0220 Other descriptive name: 7-beta-hydroxyepiandrosterone | Hunter-Fleming Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): | United Kingdom;Sweden | ||
| 278 | EUCTR2005-001006-12-AT (EUCTR) | 02/04/2006 | 28/02/2006 | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment. | Product Name: Lisparin INN or Proposed INN: Lisuride Hydrogenmaleate Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate Trade Name: Sifrol, 0,35 mg Tablette Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Trade Name: Sifrol, 0,70 mg Tablette Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Trade Name: Cabaseril, 1,0 mg Tablette Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea Trade Name: Cabaseril, 2,0 mg Tablette Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- | Axxonis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Germany;Czech Republic;Italy;Austria | ||
| 279 | NCT00349310 (ClinicalTrials.gov) | April 2006 | 5/7/2006 | Profile of Depressive Symptoms in Parkinsons Disease | Profile of Depressive Symptoms in Parkinson's Disease (PRODEST-PD) | Parkinson Disease;Depression | Drug: Pramipexole | Boehringer Ingelheim | NULL | Completed | 18 Years | N/A | Both | 1018 | Austria;France;Germany;Italy;Netherlands;Spain;Switzerland;United Kingdom | |
| 280 | NCT00294554 (ClinicalTrials.gov) | April 2006 | 21/2/2006 | Memantine for Treatment of Cognitive Impairment in Patients With Parkinson's Disease and Dementia | Double-Blind Placebo-Controlled Trial of Memantine for Treatment of Cognitive Impairment in Patients With Parkinson's Disease and Dementia | Parkinson's Disease;Cognitive Impairment;Dementia | Drug: Memantine;Drug: Placebo Oral Tablet | Johns Hopkins University | Forest Laboratories | Completed | 50 Years | N/A | All | 20 | N/A | United States |
| 281 | NCT00467597 (ClinicalTrials.gov) | April 2006 | 27/4/2007 | Developing Objective Measures of Levodopa Induced Dyskinesia: (Study 1) | Quantification of Levodopa Induced Dyskinesia in Parkinson Disease: Developing Objective Measures of Levodopa Induced Dyskinesia (Study One) | Dyskinesias;Movement Disorders;Parkinson Disease | Drug: Levodopa (delivered intravenously) | VA Office of Research and Development | Oregon Health and Science University | Completed | 21 Years | N/A | All | 36 | N/A | United States |
| 282 | NCT00461942 (ClinicalTrials.gov) | April 2006 | 17/4/2007 | Efficacy and Safety of Green Tea Polyphenol in De Novo Parkinson's Disease Patients | A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Neuroprotection Effect of Green Tea Polyphenol in De Novo Parkinson's Disease Patients | Parkinson's Disease | Drug: Green Tea Polyphenols (EGCG/ECG) | Xuanwu Hospital, Beijing | Ministry of Health, China;Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | N/A | Both | 480 | Phase 2 | China |
| 283 | NCT00646204 (ClinicalTrials.gov) | April 2006 | 28/12/2007 | Namenda (Memantine) for Non-Motor Symptoms in Parkinson's Disease | A 16 WEEK, INVESTIGATOR-INITIATED, SINGLE-CENTER, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF NAMENDA® (MEMANTINE HCL) FOR NON-MOTOR SYMPTOMS IN PARKINSON'S DISEASE | Parkinson's Disease | Drug: Memantine;Drug: placebo | Baylor College of Medicine | Forest Laboratories | Completed | 18 Years | 80 Years | Both | 40 | Phase 4 | United States |
| 284 | EUCTR2005-001006-12-DE (EUCTR) | 09/03/2006 | 05/09/2006 | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO | Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment. MedDRA version: 9.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated | Product Name: Lisparin INN or Proposed INN: Lisuride Hydrogenmaleate Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Product Name: Pramipexol INN or Proposed INN: Pramipexol Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea Product Name: Cabergoline INN or Proposed INN: Cabergoline Other descriptive name: 1[(6- Allyl- 8ß- erg | Axxonis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2;Phase 3 | Czech Republic;Austria;Germany;Italy | ||
| 285 | NCT01683292 (ClinicalTrials.gov) | January 2006 | 7/9/2012 | Single-Centre Study of VR040(Inhaled Apomorphine) in Idiopathic Parkinson's Disease | An Ascending-Dose, Single-Centre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040(Inhaled Apomorphine)in Parkinson's Disease | Parkinson's Disease | Drug: Inhaled VR040;Drug: Placebo for VR040 | South Glasgow University Hospitals NHS Trust | Vectura Limited | Completed | 30 Years | N/A | Both | 29 | Phase 2 | United Kingdom |
| 286 | EUCTR2005-005120-13-GB (EUCTR) | 21/12/2005 | 02/11/2005 | A clinic based, Phase IIa, randomised, double-blind, placebo-controlled, ascending dose, single centre study investigating the safety, tolerability, efficacy, and pharmacokinetics of VR040 in patients with established idiopathic Parkinson’s Disease | A clinic based, Phase IIa, randomised, double-blind, placebo-controlled, ascending dose, single centre study investigating the safety, tolerability, efficacy, and pharmacokinetics of VR040 in patients with established idiopathic Parkinson’s Disease | Hypomobility (off” or freezing”) episodes associated with advanced Parkinson’s disease | Product Name: Apomorphine hydrochloride Product Code: VR040 INN or Proposed INN: apomorphine hydrochloride | Vectura Group plc | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United Kingdom | ||
| 287 | NCT00472355 (ClinicalTrials.gov) | October 2005 | 10/5/2007 | Low Dose Apomorphine and Parkinsonism | Does Presynaptic Dopamine Receptor Stimulation Transiently Worsen Parkinsonism? | Parkinson's Disease | Drug: apomorphine | Oregon Health and Science University | National Institute of Neurological Disorders and Stroke (NINDS) | Withdrawn | 35 Years | 85 Years | All | 0 | Phase 2 | United States |
| 288 | EUCTR2004-001485-41-GB (EUCTR) | 26/07/2005 | 21/06/2005 | A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/A | A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/A | Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria). | Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: carbidopa/levodopa Trade Name: Cabaser Product Name: Cabaseril INN or Proposed INN: Cabergoline Trade Name: DaTSCAN Product Name: DatSCAN INN or Proposed INN: Ioflupane [123 I] | Institute for Neurodegenerative Disorders | NULL | Not Recruiting | Female: yes Male: yes | 120 | United Kingdom;Spain | |||
| 289 | EUCTR2004-001485-41-ES (EUCTR) | 28/04/2005 | 30/01/2006 | A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease | A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease | Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria). | Trade Name: SINEMET Product Name: carbodopa/levadopa INN or Proposed INN: CARBODOPA LEVADOPA Trade Name: SOLIGEN Product Name: Cabergoline INN or Proposed INN: CABERGOLINA Trade Name: DaTSCAN INN or Proposed INN: Ioflupane [123I] | Institute for Neurodegenerative Disorders | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | United Kingdom;Spain | |||
| 290 | EUCTR2004-001485-41-AT (EUCTR) | 20/04/2005 | 16/03/2005 | A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/A | A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/A | Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria). | Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: carbidopa/levodopa Trade Name: Cabaseril Product Name: Cabaseril INN or Proposed INN: Cabergoline Trade Name: DaTSCAN Product Name: DatSCAN INN or Proposed INN: Ioflupane [123 I] | Institute for Neurodegenerative Disorders | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Spain;Austria;United Kingdom | |||
| 291 | NCT00108667 (ClinicalTrials.gov) | April 2005 | 15/4/2005 | Talampanel to Treat Parkinson's Disease | AMPA Receptor Antagonist Treatment of Parkinson's Disease | Parkinson Disease | Drug: IV Levodopa;Drug: Talampanel | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 40 | Phase 2 | United States |
| 292 | NCT00199355 (ClinicalTrials.gov) | April 2005 | 12/9/2005 | A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa | Placebo-Controlled , Double-Blind , Exploratory Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Adjunctive Therapy to Levodopa] | Parkinson's Disease | Drug: Istradefylline (KW-6002) | Kyowa Hakko Kirin Company, Limited | NULL | Completed | 30 Years | N/A | Both | 75 | Phase 2 | Japan |
| 293 | NCT00375778 (ClinicalTrials.gov) | April 2005 | 12/9/2006 | Parkinson's Disease Evaluated by PET and the Effect of Memantine | Parkinson's Disease Evaluated by Positron Emission Tomography and the Effect of the NMDA Receptor Antagonist Memantine | Parkinson's Disease | Drug: memantine (drug) | University of Aarhus | Lundbeck Foundation | Completed | 50 Years | 70 Years | Both | 12 | N/A | Denmark |
| 294 | NCT00058838 (ClinicalTrials.gov) | April 2003 | 14/4/2003 | Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease | A Phase III, Double-Blind, Placebo-Controlled, Fixed-Dose Response Study Comparing the Efficacy and Safety of Sumanirole Versus Placebo in Patients With Early Parkinson's Disease. | Parkinson Disease | Drug: sumanirole | Pfizer | NULL | Completed | 30 Years | N/A | Both | 854 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Colombia;France;Germany;Greece;Italy;Mexico;Peru;Puerto Rico;Spain |
| 295 | NCT00058721 (ClinicalTrials.gov) | April 2003 | 11/4/2003 | Single Photon Emission Computed Tomography to Study Receptors in Parkinson's Disease | SPECT Evaluation of Nicotinic Cholinergic Receptors in Parkinson's Disease | Parkinson Disease | Drug: I-123-5-IA85380 | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 60 | N/A | United States |
| 296 | NCT00040209 (ClinicalTrials.gov) | June 2002 | 21/6/2002 | JP-1730 to Treat Parkinson's Disease | Alpha-2 Adrenergic Antagonist Treatment of Parkinson's Disease | Parkinson Disease | Drug: JP 1730;Drug: IV Levodopa;Drug: IV Apomorphine | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 30 | Phase 2 | United States |
| 297 | NCT00456586 (ClinicalTrials.gov) | April 2002 | 3/4/2007 | 12-Week, Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy of 40 mg/Day KW-6002 in Parkinson's Disease Patients on Levodopa/Carbidopa | A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of 40 mg/Day KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy | Parkinson's Disease | Drug: KW-6002 (istradefylline) | Kyowa Kirin Pharmaceutical Development, Inc. | NULL | Completed | 30 Years | N/A | Both | 180 | Phase 2 | United States |
| 298 | NCT00200525 (ClinicalTrials.gov) | July 2001 | 13/9/2005 | Continued Efficacy and Safety of Apomorphine in Patients With Late-Stage Parkinsons Disease | A Randomized, Placebo-Controlled Study of the Continued Efficacy and Safety of SC Apomorphine in the Treatment of Off Episodes in Patients With On/Off or Wearing-Off Effects Associated With Late-Stage PD After Apomorphine Use | Parkinson Disease | Drug: apomorphine HCl injection | Mylan Bertek Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 60 | Phase 3 | NULL |
| 299 | NCT02763839 (ClinicalTrials.gov) | April 2001 | 4/5/2016 | Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Carbidopa (100/25 mg) | Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Carbidopa (100/25 mg): a Double-blind, Randomised, Crossover, Placebo Controlled Study in Healthy Volunteers | Parkinson's Disease | Drug: BIA 3-202;Drug: Placebo;Drug: Sinemet 25/100 | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Both | 19 | Phase 1 | Portugal |
| 300 | NCT02763852 (ClinicalTrials.gov) | April 2001 | 4/5/2016 | Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg) | Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg): a Double-blind, Randomised, Crossover, Placebo Controlled Study in Healthy Volunteers | Parkinson's Disease | Drug: BIA 3-202;Drug: Placebo;Drug: Madopar® 125 | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Both | 18 | Phase 1 | Portugal |
| 301 | NCT00145171 (ClinicalTrials.gov) | February 2001 | 2/9/2005 | A Sub-Study With Patients in APO401 to Evaluate Adverse Events During Dose Introduction in Apomorphine-naïve Patients. | Study of Orthostatic Changes Upon Apomorphine Dose Initiation in Late Stage Parkinson’s Disease Patients. A Dose Escalation Study With a Double-Blind Placebo-Controlled Efficacy Determination at 4 Mg. | Parkinson Disease | Drug: apomorphine HCl injection | Mylan Bertek Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 56 | Phase 3 | NULL |
| 302 | NCT00134784 (ClinicalTrials.gov) | April 2000 | 23/8/2005 | Long-Term Dopamine Transporter Imaging and Clinical Assessment of Parkinson's Disease Progression | [123I]ß-CIT and SPECT in Vivo Three Year Imaging Assessment of Dopamine Transporter Density in Subjects With Early Parkinson's Disease Participating in Earlier vs. Later Levodopa in Parkinson's Disease | Parkinson Disease | Drug: [123I]B-CIT SPECT imaging | Institute for Neurodegenerative Disorders | United States Department of Defense | Completed | 22 Years | N/A | All | 142 | Phase 2 | NULL |
| 303 | NCT02763787 (ClinicalTrials.gov) | April 2000 | 4/5/2016 | Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of BIA 3-202 | A Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of Single Doses of BIA 3-202 in Healthy Volunteers. | Parkinson's Disease | Drug: BIA 3-202;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 18 Years | 35 Years | Male | 71 | Phase 1 | United Kingdom |
| 304 | NCT00200512 (ClinicalTrials.gov) | September 1999 | 13/9/2005 | Continued Efficacy of Apomorphine After Previous Exposure of at Least Three Months | A Prospective, Randomized, Placebo-Controlled, Crossover Study of the Safety and Effectiveness of Subcutaneous Injections of Apomorphine in the Treatment of Off Episodes in Patients With On/Off or Wearing Off Effects Associated With Late Stage Parkinson's Disease | Parkinson Disease | Drug: apomorphine HCl injection | Mylan Bertek Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 16 | Phase 2/Phase 3 | United Kingdom |
| 305 | NCT00142545 (ClinicalTrials.gov) | July 1999 | 31/8/2005 | Long Term Safety and Efficacy of SC Apomorphine in Treatment of Off Episodes in Late-Stage Parkinson's Disease | Long-Term Safety and Effectiveness of Subcutaneous Injections of Apomorphine in the Treatment of Off” Episodes in Patients With On-Off” or Wearing-Off” Effects Associated With Late-Stage Parkinson’s Disease | Parkinson Disease | Drug: apomorphine HCl injection | Mylan Bertek Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 800 | Phase 3 | United States |
| 306 | NCT00001931 (ClinicalTrials.gov) | May 1999 | 31/7/2007 | Treatment of Parkinson's Disease With a Transdermal Skin Patch | Transdermal Application of Dopamine Agonist N-0923 in Parkinson's Disease | Parkinson Disease | Drug: N-0923 | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | N/A | N/A | Both | 20 | Phase 2 | United States |
| 307 | NCT02172573 (ClinicalTrials.gov) | April 1999 | 20/6/2014 | Safety and Efficacy of Pramipexole and Bromocriptine Combined With L-dopa in Parkinson's Disease | A Double-blind, Placebo-controlled, Randomised, Multicenter Trial to Compare the Safety and Efficacy of Oral Administration of Pramipexole up to 4.5mg and Bromocriptine up to 22.5mg Combined With L-dopa in Advanced Parkinson's Disease | Parkinson Disease | Drug: Pramipexole;Drug: Bromocriptine;Drug: Placebo pramipexole;Drug: Placebo bromocriptine | Boehringer Ingelheim | NULL | Completed | 20 Years | N/A | Both | 315 | Phase 3 | NULL |
| 308 | EUCTR2008-004447-11-DE (EUCTR) | 17/10/2008 | A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease | A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease | Unpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease MedDRA version: 11;Level: LLT;Classification code 10067209;Term: | Product Name: Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride Product Name: Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed Product Code: VR040 INN or Proposed INN: Apomorphine hydrochloride | Vectura Limited | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | Germany;Italy;United Kingdom |
13. 多発性硬化症／視神経脊髄炎
臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05658484 (ClinicalTrials.gov) | April 13, 2023 | 12/12/2022 | A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China | A Multicenter, Postmarketing Study of Dimethyl Fumarate (Tecfidera; BG00012) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China | Multiple Sclerosis | Drug: Dimethyl fumarate | Biogen | NULL | Not yet recruiting | 18 Years | 65 Years | All | 60 | Phase 4 | NULL |
| 2 | NCT05754593 (ClinicalTrials.gov) | April 2023 | 21/2/2023 | Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis (MS), Compared to a Control Group | Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis, Compared to a Control Group | Multiple Sclerosis | Biological: Anti-Mullerian hormone (AMH) level;Other: Antral follicle count (AFC);Other: Clinical assessment | University Hospital, Bordeaux | NULL | Not yet recruiting | 25 Years | 35 Years | Female | 160 | N/A | France |
| 3 | NCT05349474 (ClinicalTrials.gov) | April 26, 2022 | 21/4/2022 | Metformin Treatment in Progressive Multiple Sclerosis | A Double-blind, Placebo Controlled Trial of Metformin Treatment in Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis;Primary Progressive Multiple Sclerosis | Drug: Metformin 500 Mg Oral Tablet, up to 4 tablets a day;Drug: Placebo oral tablet identical to metformin, up to 4 tablets a day | University of California, Los Angeles | NULL | Recruiting | 30 Years | 65 Years | All | 44 | Early Phase 1 | United States |
| 4 | EUCTR2021-000028-36-LT (EUCTR) | 21/04/2022 | 04/11/2021 | Not applicable | A Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-1) - ENSURE-1 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IMU-838 Product Name: Vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IMU-838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1050 | Phase 3 | United States;Belarus;Greece;Ukraine;Lithuania;Russian Federation;North Macedonia;Colombia;India;Mexico;Poland;Bulgaria;Albania;Georgia;Moldova, Republic of | ||
| 5 | NCT05296161 (ClinicalTrials.gov) | April 20, 2022 | 18/2/2022 | B Cell Tailored Ocrelizumab Versus Standard Ocrelizumab in Relapsing Remitting Multiple Sclerosis | Efficacy, Safety and Cost-effectiveness of B Cell Tailored Ocrelizumab Versus Standard Ocrelizumab in Relapsing Remitting Multiple Sclerosis: a Randomized Controlled Trial | Multiple Sclerosis, Relapsing-Remitting | Drug: Ocrelizumab | Amsterdam UMC, location VUmc | NULL | Recruiting | 18 Years | 60 Years | All | 296 | Phase 4 | Netherlands |
| 6 | NCT04998812 (ClinicalTrials.gov) | April 13, 2022 | 6/8/2021 | A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy | A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy | Multiple Sclerosis;Clinically Isolated Syndrome | Drug: Ocrelizumab | Hoffmann-La Roche | PPD;Laboratory Corporation of America;Illingworth Research Group | Recruiting | 18 Years | 40 Years | Female | 44 | Phase 4 | Switzerland;United Kingdom;France;Germany;Spain;United States;Canada;Italy |
| 7 | NCT05417269 (ClinicalTrials.gov) | April 12, 2022 | 1/6/2022 | IMCY-0141 Safety and Efficacy in Multiple Sclerosis - ISEMIS Study | A Phase I/II Dose Escalation/Adaptive Design Study to Evaluate the Safety and Efficacy of IMCY-0141 in Patients With Relapsing Remitting-Multiple Sclerosis (RR-MS) | Multiple Sclerosis, Relapsing-Remitting | Drug: IMCY-0141;Drug: Placebo;Drug: Dimethyl Fumarate | Imcyse SA | NULL | Recruiting | 18 Years | 45 Years | All | 150 | Phase 1/Phase 2 | Moldova, Republic of |
| 8 | NCT05145361 (ClinicalTrials.gov) | April 7, 2022 | 21/11/2021 | Clinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD) | A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of B001 in Subjects With Aquaporin-4 Antibody (AQP4-IgG) Positive Neuromyelitis Optic Spectrum Disorder (NMOSD) | NMO Spectrum Disorder | Drug: B001 injection;Biological: Placebo | Shanghai Pharmaceuticals Holding Co., Ltd | NULL | Recruiting | 18 Years | 70 Years | All | 45 | Early Phase 1 | China |
| 9 | NCT05319093 (ClinicalTrials.gov) | April 2022 | 1/4/2022 | Observational Study of the Effect of Ozanimod on Fatigue in Multiple Sclerosis Patients | Observational Study of the Effect of Ozanimod on Fatigue in Multiple Sclerosis Patients | Fatigue;Multiple Sclerosis | Drug: Ozanimod | Brigham and Women's Hospital | Bristol-Myers Squibb | Not yet recruiting | 18 Years | N/A | All | 40 | NULL | |
| 10 | NCT05284175 (ClinicalTrials.gov) | April 2022 | 9/3/2022 | A Study of Orelabrutinib in Patients With AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder | A Prospective, Self-controlled Study to Explore Efficacy and Safety of Orelabrutinib in AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder | Neuromyelitis Optica Spectrum Disorder | Drug: Orelabrutinib | Peking Union Medical College Hospital | Beijing InnoCare Pharma Tech Co., Ltd.;GCP ClinPlus Co., Ltd. | Not yet recruiting | 18 Years | 75 Years | All | 23 | N/A | China |
| 11 | EUCTR2021-000028-36-BG (EUCTR) | 18/01/2022 | 08/11/2021 | Not applicable | A Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-1) - ENSURE-1 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IMU-838 Product Name: Vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IMU-838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1050 | Phase 3 | Colombia;Russian Federation;United States;Ukraine;Belarus;India;Albania;Greece;Moldova, Republic of;Poland;North Macedonia;Mexico;Georgia;Bulgaria;Lithuania | ||
| 12 | EUCTR2021-000063-79-DE (EUCTR) | 25/11/2021 | 25/08/2021 | A Study to Evaluate B Cell Levels in Infants of Lactating Women with Clinically Isolated Syndrome or Multiple sclerosis Receiving Ocrelizumab | A PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS OF LACTATING WOMEN WITH CIS OR MS RECEIVING OCRELIZUMAB – THE SOPRANINO STUDY | Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications] MedDRA version: 20.0;Level: PT;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 4 | France;United States;Canada;Spain;Germany;United Kingdom;Switzerland;Italy | ||
| 13 | EUCTR2021-000062-14-DE (EUCTR) | 25/11/2021 | 25/08/2021 | A Study to Evaluate B Cell Levels in Infants Potentially Exposed to Ocrelizumab During Pregnancy | A PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS POTENTIALLY EXPOSED TO OCRELIZUMAB DURING PREGNANCY – THE MINORE STUDY | Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications] MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 4 | France;United States;Canada;Spain;Germany;United Kingdom;Switzerland;Italy | ||
| 14 | EUCTR2021-000063-79-ES (EUCTR) | 22/10/2021 | 23/07/2021 | A Study to Evaluate B Cell Levels in Infants of Lactating Women with Clinically Isolated Syndrome or Multiple sclerosis Receiving Ocrelizumab | A PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS OF LACTATING WOMEN WITH CIS OR MS RECEIVING OCRELIZUMAB – THE SOPRANINO STUDY | Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications] MedDRA version: 20.0;Level: PT;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 4 | France;United States;Canada;Spain;Australia;Germany;United Kingdom;Switzerland;Italy | ||
| 15 | EUCTR2021-000062-14-ES (EUCTR) | 08/10/2021 | 23/07/2021 | A Study to Evaluate B Cell Levels in Infants Potentially Exposed to Ocrelizumab During Pregnancy | A PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS POTENTIALLY EXPOSED TO OCRELIZUMAB DURING PREGNANCY – THE MINORE STUDY | Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications] MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 4 | France;United States;Canada;Spain;Australia;Germany;United Kingdom;Switzerland;Italy | ||
| 16 | EUCTR2019-001341-40-SI (EUCTR) | 20/08/2021 | 12/07/2021 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from fumarate-based RMS approved therapies or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes (PRO) in patients with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies or fingolimod | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Saudi Arabia;Estonia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Switzerland;Italy;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 17 | EUCTR2020-004785-19-DE (EUCTR) | 07/07/2021 | 17/02/2021 | Proof-of-concept study for SAR441344 in relapsing multiple sclerosis | A Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SAR441344 Product Code: SAR441344 INN or Proposed INN: Not Applicable Other descriptive name: SAR441344 | Sanofi-Aventis Recherche et Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | France;United States;Czechia;Czech Republic;Canada;Spain;Turkey;Russian Federation;Bulgaria;Germany | ||
| 18 | EUCTR2020-004785-19-CZ (EUCTR) | 01/06/2021 | 05/02/2021 | Proof-of-concept study for SAR441344 in relapsing multiple sclerosis | A Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SAR441344 Product Code: SAR441344 INN or Proposed INN: Not Applicable Other descriptive name: SAR441344 | Sanofi-Aventis Recherche et Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | France;United States;Czechia;Czech Republic;Canada;Spain;Turkey;Bulgaria;Russian Federation;Germany | ||
| 19 | EUCTR2020-003995-42-IT (EUCTR) | 13/05/2021 | 04/06/2021 | Extension to the MAGNIFY MS trial on Mavenclad® | A 2-year extension study to evaluate long-term effectiveness of Mavenclad® in participants who have completed Trial MS700568_0022 (MAGNIFY MS) - Magnify MS Extension | Highly-active relapsing multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD - 10 MG - COMPRESSA - USO ORALE - BLISTER (AL/AL) - 6 COMPRESSE Product Name: Cladribine tablets Product Code: [Not Applicable] INN or Proposed INN: CLADRIBINA | MERCK KGAA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 261 | Phase 4 | Hungary;Czech Republic;Canada;Finland;Poland;Australia;Israel;Germany;Italy | ||
| 20 | NCT04540861 (ClinicalTrials.gov) | April 30, 2021 | 31/8/2020 | Managed Access Program (MAP) for Patients Diagnosed With Secondary Progressive Multiple Sclerosis With Active Disease | Managed Access Program (MAP) to Provide Access to Siponimod Treatment for Patients Diagnosed With Secondary Progressive Multiple Sclerosis With no Satisfactory Alternative Treatment | Multiple Sclerosis | Drug: Siponimod | Novartis Pharmaceuticals | NULL | Available | 18 Years | N/A | All | NULL | ||
| 21 | NCT04688788 (ClinicalTrials.gov) | April 28, 2021 | 22/12/2020 | Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple Sclerosis | Danish Non-inferiority Study of Ocrelizumab and Rituximab in MS (DanNORMS): A Randomized Study Comparing the Efficacy of Ocrelizumab and Rituximab in Active Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Primary Progressive Multiple Sclerosis | Drug: Rituximab;Drug: Ocrelizumab;Drug: Fexofenadine;Drug: Paracetamol;Drug: Methylprednisolone | Rigshospitalet, Denmark | Odense University Hospital;Aarhus University Hospital;Aalborg University Hospital;Herlev Hospital;Hillerod Hospital, Denmark;Zealand University Hospital;Kolding Sygehus;Regional Hospital Holstebro;Hvidovre University Hospital;Hospital of South West Jutland, Esbjerg, Denmark;GCP unit, Copenhagen University Hospital;GCP-unit at Aarhus University Hospital, Aarhus, Denmark;Hospital of Southern Jutland, Sønderborg, Denmark;Hospital of Central Denmark Region, Viborg, Denmark;Danske Regioner | Recruiting | 18 Years | 65 Years | All | 594 | Phase 3 | Denmark |
| 22 | EUCTR2020-004785-19-BG (EUCTR) | 28/04/2021 | 09/03/2021 | Proof-of-concept study for SAR441344 in relapsing multiple sclerosis | A Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SAR441344 Product Code: SAR441344 INN or Proposed INN: Not Applicable Other descriptive name: SAR441344 | Sanofi-Aventis Recherche et Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | France;United States;Czechia;Czech Republic;Canada;Spain;Turkey;Russian Federation;Bulgaria;Germany | ||
| 23 | NCT04843774 (ClinicalTrials.gov) | April 20, 2021 | 9/4/2021 | Vaccine-generated Immunity in Ocrelizumab-treated Patients: Longitudinal Assessments (VIOLA) | Vaccine-generated Immunity in Ocrelizumab-treated Patients: Longitudinal Assessments (VIOLA) | Multiple Sclerosis | Drug: SARS-COV-2 mRNA Vaccine | NYU Langone Health | NULL | Active, not recruiting | 18 Years | 65 Years | All | 64 | United States | |
| 24 | NCT04792567 (ClinicalTrials.gov) | April 19, 2021 | 8/3/2021 | Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC) | An Open-label Multicenter Study to Assess Response to SARS-CoV-2 modRNA Vaccines in Participants With Secondary Progressive Multiple Sclerosis Treated With Mayzent (Siponimod) | Secondary Progressive Multiple Sclerosis | Drug: BAF312;Drug: Baseline disease modifying therapies (DMTs) | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 100 Years | All | 41 | Phase 4 | Germany |
| 25 | NCT04742400 (ClinicalTrials.gov) | April 15, 2021 | 5/2/2021 | Tolebrutinib, a Brain-penetrant Bruton s Tyrosine Kinase Inhibitor, for the Modulation of Chronically Inflamed White Matter Lesions in Multiple Sclerosis | A Phase 2 Clinical Trial of Tolebrutinib, a Brain-penetrant Bruton's Tyrosine Kinase Inhibitor, for the Modulation of Chronically Inflamed White Matter Lesions in Multiple Sclerosis | Multiple Sclerosis | Drug: tolebrutinib 60mg;Drug: tolebrutinib 120mg | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Active, not recruiting | 18 Years | N/A | All | 11 | Phase 2 | United States |
| 26 | EUCTR2020-003874-30-DK (EUCTR) | 06/04/2021 | 23/11/2020 | Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® dose | A 2-year follow-up study to assess cognition and health-related quality oflife in participants with highly-active relapsing multiple sclerosis, havingparticipated in the CLARIFY MS trial - CLARIFY MS Extension | Highly-active relapsing multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad Product Name: Cladribine tablets Product Code: Not applicable | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 4 | Hungary;Denmark | ||
| 27 | NCT05385744 (ClinicalTrials.gov) | April 5, 2021 | 18/5/2022 | An International, Multicenter, Randomized, Double-Blind, Double-Masked Study of the Efficacy and Safety of BCD-132 (JSC BIOCAD, Russia) Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis | An International, Multicenter, Randomized, Double-Blind, Double-Masked Study of the Efficacy and Safety of BCD-132 (JSC BIOCAD, Russia) Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis | Multiple Sclerosis | Biological: BCD-132;Drug: Teriflunomide | Biocad | NULL | Recruiting | 18 Years | 60 Years | All | 336 | Phase 3 | Russian Federation |
| 28 | JPRN-jRCT2031200333 | 02/03/2021 | 29/01/2021 | A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) | A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) | Neuromyelitis Optica Spectrum Disorder (NMOSD) | Satralizumab: 120 mg SC injection every 4 weeks (Q4W) | Hans-Christian von Buedingen | NULL | Not Recruiting | Not applicable | Not applicable | Both | 127 | Phase 4 | Italy;Taiwan;United States;Poland;Canada;United Kingdom;Ukraine;Bulgaria;Turkey;Korea;Romania;Georgia;Malaysia;Croatia;Hungary;Spain;Germany;Japan |
| 29 | EUCTR2020-003874-30-CZ (EUCTR) | 03/02/2021 | 04/11/2020 | Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® dose | A 2-year follow-up study to assess cognition and health-related quality of life in participants with highly-active relapsing multiple sclerosis, having participated in the CLARIFY MS trial - CLARIFY MS Extension | Highly-active relapsing multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad Product Name: Cladribine tablets Product Code: Not applicable | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 4 | Hungary;Czech Republic;Denmark;Italy | ||
| 30 | EUCTR2020-003995-42-CZ (EUCTR) | 03/02/2021 | 04/11/2020 | Extension to the MAGNIFY MS trial on Mavenclad® | A 2-year extension study to evaluate long-term effectiveness of Mavenclad® in participants who have completed Trial MS700568_0022 (MAGNIFY MS) - Magnify MS Extension | Highly-active relapsing multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad Product Name: Cladribine tablets Product Code: Not applicable | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 261 | Phase 4 | Hungary;Czech Republic;Canada;Finland;Australia;Israel;Germany | ||
| 31 | EUCTR2020-003995-42-AT (EUCTR) | 26/01/2021 | 23/11/2020 | Extension to the MAGNIFY MS trial on Mavenclad® | A 2-year extension study to evaluate long-term effectiveness of Mavenclad® in participants who have completed Trial MS700568_0022 (MAGNIFY MS) - Magnify MS Extension | Highly-active relapsing multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: CLADRIBINE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 256 | Phase 4 | Hungary;Czech Republic;Canada;Finland;Poland;Australia;Austria;Israel;Germany;Italy | ||
| 32 | EUCTR2019-001341-40-PL (EUCTR) | 20/01/2021 | 17/07/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from fumarate-based RMS approved therapies or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes (PRO) in patients with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies or fingolimod | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Saudi Arabia;Estonia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 33 | EUCTR2020-003995-42-HU (EUCTR) | 18/01/2021 | 20/11/2020 | Extension to the MAGNIFY MS trial on Mavenclad® | A 2-year extension study to evaluate long-term effectiveness of Mavenclad® in participants who have completed Trial MS700568_0022 (MAGNIFY MS) - Magnify MS Extension | Highly-active relapsing multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad Product Name: Cladribine tablets Product Code: Not applicable | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 47 | Phase 4 | Czech Republic;Hungary;Canada;Finland;Australia;Israel;Germany | ||
| 34 | EUCTR2020-003874-30-HU (EUCTR) | 15/01/2021 | 20/11/2020 | Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® dose | A 2-year follow-up study to assess cognition and health-related quality of life in participants with highly-active relapsing multiple sclerosis, having participated in the CLARIFY MS trial - CLARIFY MS Extension | Highly-active relapsing multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: CLADRIBINE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 4 | Hungary | ||
| 35 | EUCTR2020-003874-30-IT (EUCTR) | 08/01/2021 | 24/05/2021 | Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® dose | A 2-year follow-up study to assess cognition and health-related quality of life in participants with highly-active relapsing multiple sclerosis, having participated in the CLARIFY MS trial - CLARIFY MS Extension | Highly-active relapsing multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD - 10 MG - COMPRESSA - USO ORALE - BLISTER (AL/AL) - 6 COMPRESSE Product Name: Cladribine tablets Product Code: [Not Applicable] INN or Proposed INN: CLADRIBINA | MERCK KGAA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 4 | France;Czechia;Hungary;Slovakia;Spain;Poland;Denmark;Austria;Netherlands;Italy | ||
| 36 | EUCTR2020-003874-30-AT (EUCTR) | 29/12/2020 | 23/11/2020 | Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® dose | A 2-year follow-up study to assess cognition and health-related quality of life in participants with highly-active relapsing multiple sclerosis, having participated in the CLARIFY MS trial - CLARIFY MS Extension | Highly-active relapsing multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: CLADRIBINE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 4 | Hungary;Czech Republic;Denmark;Austria;Italy | ||
| 37 | EUCTR2020-003995-42-DE (EUCTR) | 18/12/2020 | 29/10/2020 | Extension to the MAGNIFY MS trial on Mavenclad® | A 2-year extension study to evaluate long-term effectiveness of Mavenclad® in participants who have completed Trial MS700568_0022 (MAGNIFY MS) - Magnify MS Extension | Highly-active relapsing multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad Product Name: Cladribine tablets Product Code: Not applicable | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 256 | Phase 4 | Hungary;Czech Republic;Canada;Finland;Poland;Australia;Israel;Germany | ||
| 38 | EUCTR2020-003995-42-FI (EUCTR) | 15/12/2020 | 23/11/2020 | Extension to the MAGNIFY MS trial on Mavenclad® | A 2-year extension study to evaluate long-term effectiveness of Mavenclad® in participants who have completed Trial MS700568_0022 (MAGNIFY MS) - Magnify MS Extension | Highly-active relapsing multiple sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: CLADRIBINE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 256 | Phase 4 | Canada;Finland;Australia;Israel;Germany | ||
| 39 | JPRN-jRCT2051210017 | 15/10/2020 | 07/05/2021 | An extension study for seven patients in Japan with neuromyelitis optica spectrum disorder who completed the open-label period of study CD-IA-MEDI-551-1155 of Inebilizumab | An extension study for seven patients in Japan with neuromyelitis optica spectrum disorder who completed the open-label period of study CD-IA-MEDI-551-1155 of Inebilizumab | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | This study is designed to provide the opportunity of continued access to inebilizumab to patients with NMOSD who received inebilizumab in the completed Study CD-IA-MEDI-551-1155. The fixed dose of 300 mg inebilizumab every 26 weeks is injected to maintain peripheral B-cell suppression in subjects. | Sato Toshiyuki | NULL | Not Recruiting | >= 18age old | Not applicable | Both | 7 | Phase 3 | Japan |
| 40 | EUCTR2019-001341-40-AT (EUCTR) | 10/09/2020 | 07/07/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from fumarate-based RMS approved therapies or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes (PRO) in patients with relapsing multiple sclerosis(RMS) transitioning from fumarate-based RMS approved therapies or fingolimod therapy | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Switzerland;Italy;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 41 | EUCTR2019-004972-20-IT (EUCTR) | 31/08/2020 | 21/01/2021 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 1) | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Evobrutinib Product Code: [M2951] INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: AUBAGIO Product Name: Aubagio Product Code: [non applicabile] INN or Proposed INN: TERIFLUNOMIDE | MERCK HEALTHCARE KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | Canada;Argentina;Poland;Belgium;Croatia;Georgia;Serbia;United States;Estonia;Hong Kong;Taiwan;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;India;France;Australia;Peru;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Bulgaria;Germany | ||
| 42 | EUCTR2019-004980-36-IT (EUCTR) | 31/08/2020 | 21/01/2021 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Evobrutinib Product Code: [M2951] INN or Proposed INN: Evobrutinib Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio Product Code: [non applicabile] INN or Proposed INN: TERIFLUNOMIDE | MERCK HEALTHCARE KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | Portugal;Belarus;United States;Philippines;Saudi Arabia;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Kuwait;Tunisia;Latvia;Moldova, Republic of;Slovenia;Lithuania;Turkey;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden | ||
| 43 | EUCTR2019-001341-40-SK (EUCTR) | 20/07/2020 | 16/03/2020 | An open-label study evaluating ofatumumab treatment effectiveness andPROs in subjects with RMS transitioning from fumarate-based RMSapproved therapies or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluateofatumumab treatment effectiveness and patient-reported outcomes (PRO)in patients with relapsing multiple sclerosis (RMS) transitioning fromfumarate-based RMS approved therapies or fingolimod | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;Norway | ||
| 44 | NCT04353492 (ClinicalTrials.gov) | July 14, 2020 | 16/4/2020 | An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab | A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient-reported Outcomes (PRO) in Patients With Relapsing Multiple Sclerosis (RMS) Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod | Relapsing Multiple Sclerosis | Biological: Ofatumumab | Novartis Pharmaceuticals | NULL | Active, not recruiting | 18 Years | 60 Years | All | 564 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;Estonia;Germany;Greece;Hungary;Italy;Latvia;Lebanon;Mexico;Norway;Poland;Portugal;Russian Federation;Saudi Arabia;Slovakia;Slovenia;Spain;Switzerland;Turkey;United Kingdom |
| 45 | EUCTR2017-003008-30-GB (EUCTR) | 01/07/2020 | 17/05/2018 | Simvastatin in Secondary Progressive Multiple Sclerosis | A double-blind, randomised, placebo-controlled single-site study of high dose simvastatin treatment for secondary progressive multiple sclerosis: impact on vascular perfusion and oxidative damage - MS-OPT Version 1.3 dated 23/05/18 | Multiple Sclerosis (Secondary Progressive) MedDRA version: 20.0;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Simvastatin 40 mg film-coated tablets Product Name: Simvastatin 40 mg film-coated tablets Product Code: Not applicable INN or Proposed INN: Simvastatin | University College London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United Kingdom | ||
| 46 | EUCTR2019-001341-40-BG (EUCTR) | 12/06/2020 | 07/05/2020 | An open-label study evaluating ofatumumab treatment effectiveness andPROs in subjects with RMS transitioning from fumarate-based RMSapproved therapies or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluateofatumumab treatment effectiveness and patient-reported outcomes (PRO)in patients with relapsing multiple sclerosis (RMS) transitioning fromfumarate-based RMS approved therapies or fingolimod | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;Norway | ||
| 47 | EUCTR2019-000069-19-RO (EUCTR) | 29/05/2020 | 22/03/2022 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | France;Australia;Tunisia;Latvia;Korea, Republic of;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Norway;Sweden;Portugal;United States;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy | ||
| 48 | EUCTR2019-001341-40-GR (EUCTR) | 20/05/2020 | 10/03/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from fumarate-based RMS approved therapies or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies or fingolimod | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 49 | NCT05081700 (ClinicalTrials.gov) | May 11, 2020 | 13/11/2020 | A Systems Approach to Understanding Disease Processes in Multiple Sclerosis | A Systems Approach to Understanding Disease Processes in Multiple Sclerosis | Multiple Sclerosis | Drug: All patients in the study will be treated with ocrelizumab | Providence Health & Services | Institute for Systems Biology;Genentech, Inc. | Active, not recruiting | 18 Years | 60 Years | All | 14 | United States | |
| 50 | EUCTR2019-001341-40-DE (EUCTR) | 08/05/2020 | 05/03/2020 | An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from fumarate-based RMS approved therapies or fingolimod to ofatumumab | A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies or fingolimod. | Multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Kesimpta Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 555 | Phase 3 | United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway | ||
| 51 | NCT04267926 (ClinicalTrials.gov) | April 1, 2020 | 11/2/2020 | MitoQ for Fatigue in Multiple Sclerosis (MS) | MitoQ for Fatigue in Multiple Sclerosis: A Placebo Controlled Trial | Multiple Sclerosis;Fatigue | Drug: 20 mg MitoQ;Drug: Placebo;Drug: 40mg of MitoQ | VA Office of Research and Development | NULL | Recruiting | 18 Years | 70 Years | All | 60 | Phase 1/Phase 2 | United States |
| 52 | EUCTR2019-000069-19-HR (EUCTR) | 24/12/2019 | 20/02/2020 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Portugal;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 53 | EUCTR2019-000069-19-AT (EUCTR) | 20/11/2019 | 06/06/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck, S.L. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 4 | United States;Portugal;Serbia;Estonia;Morocco;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 54 | EUCTR2019-000069-19-PT (EUCTR) | 14/10/2019 | 13/05/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | Serbia;Estonia;United States;Portugal;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 55 | EUCTR2019-000069-19-IT (EUCTR) | 11/10/2019 | 01/09/2021 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: Cladribina Product Code: [Not applicable] | MERCK KGAA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 56 | EUCTR2019-000069-19-PL (EUCTR) | 08/09/2019 | 27/06/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Portugal;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 57 | EUCTR2019-000069-19-BG (EUCTR) | 05/09/2019 | 04/06/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Portugal;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 58 | EUCTR2019-000069-19-LT (EUCTR) | 27/08/2019 | 10/06/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Portugal;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 59 | EUCTR2019-000069-19-ES (EUCTR) | 23/08/2019 | 04/07/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: CLADRIBINE | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Serbia;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 60 | EUCTR2019-000069-19-SE (EUCTR) | 14/08/2019 | 10/05/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Serbia;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 61 | EUCTR2019-000069-19-CZ (EUCTR) | 12/07/2019 | 07/05/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Portugal;Serbia;Estonia;Morocco;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 62 | EUCTR2019-000069-19-EE (EUCTR) | 17/06/2019 | 22/05/2019 | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials | Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS | Multiple Sclerosis MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MAVENCLAD Product Name: Cladribine tablets Product Code: Not applicable | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;United States;Portugal | ||
| 63 | NCT03824938 (ClinicalTrials.gov) | April 30, 2019 | 9/1/2019 | Aspirin for Exercise in Multiple Sclerosis (ASPIRE) | Aspirin for Exercise in Multiple Sclerosis (ASPIRE): A Double-Blind RCT of Aspirin or Acetaminophen Pretreatment to Improve Exercise Performance in Multiple Sclerosis (MS) | Multiple Sclerosis | Drug: Aspirin 650mg Oral Capsule;Drug: Acetaminophen Tablet 650mg;Other: Placebo | Columbia University | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | 18 Years | 70 Years | All | 60 | Phase 3 | United States |
| 64 | NCT03816345 (ClinicalTrials.gov) | April 4, 2019 | 24/1/2019 | Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer | A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO) | Advanced Malignant Solid Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Hematopoietic and Lymphoid Cell Neoplasm;Inflammatory Bowel Disease;Metastatic Malignant Solid Neoplasm;Multiple Sclerosis;Psoriasis;Psoriatic Arthritis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant Solid Neoplasm | Procedure: Biospecimen Collection;Biological: Nivolumab | National Cancer Institute (NCI) | NULL | Recruiting | 18 Years | N/A | All | 300 | Phase 1 | United States;Canada |
| 65 | NCT03853746 (ClinicalTrials.gov) | April 1, 2019 | 22/2/2019 | Short-term B-cell Depletion in Relapsing Multiple Sclerosis | Evaluating the Effects of Short-term B-cell Depletion on Long-term Disease Activity and Immune Tolerance in Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab | Johns Hopkins University | National Multiple Sclerosis Society | Active, not recruiting | 18 Years | 99 Years | All | 10 | Phase 4 | United States |
| 66 | NCT03710655 (ClinicalTrials.gov) | April 2019 | 6/10/2018 | Evaluate Safety and Efficacy of Apitox Add-on Therapy for Improving Disability and Quality of Life in MS Patients | Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Apitox Add-on Therapy for Improving Disability and QOL in MS Patients | Multiple Sclerosis | Drug: Apitox - pure honeybee toxin;Drug: Placebo | Apimeds, Inc. | NULL | Unknown status | 18 Years | 65 Years | All | 468 | Phase 3 | NULL |
| 67 | NCT03889639 (ClinicalTrials.gov) | March 29, 2019 | 1/3/2019 | Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis | A Phase 2b Dose-finding Study for SAR442168, a Bruton's Tyrosine Kinase Inhibitor, in Participants With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: SAR442168;Drug: Placebo;Drug: Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI) | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 130 | Phase 2 | United States;Canada;Czechia;Estonia;France;Netherlands;Russian Federation;Slovakia;Spain;Ukraine;Sweden |
| 68 | NCT05236777 (ClinicalTrials.gov) | January 1, 2019 | 2/2/2022 | TOPIK Study: A Study to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections in Natalizumab Treated Participants | Long-term Surveillance of Patients With Multiple Sclerosis to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections Among Patients Treated With Natalizumab | Multiple Sclerosis | Drug: Natalizumab | Biogen | Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse | Recruiting | N/A | N/A | All | 600 | Czechia | |
| 69 | EUCTR2017-004158-40-FR (EUCTR) | 11/09/2018 | 04/07/2018 | NA | A Prospective study evaluating the effect of ocrelizumab on brain innate immune Microglial cells Activation in Multiple Sclerosis using PET-MRI with 18F-DPA714 - INN-MS | Patients with Relapsing MS or primary progressive MS MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrevus INN or Proposed INN: ocrelizumab Other descriptive name: ocrelizumab | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 71 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 70 | NCT03464448 (ClinicalTrials.gov) | April 17, 2018 | 7/3/2018 | Mechanistic Studies of Teriflunomide in RRMS | Mechanistic Studies of Teriflunomide in Relapsing Remitting Multiple Sclerosis: Regulatory B Lymphocytes as Central Mediators of the Therapeutic Effects of Teriflunomide in MS | Relapsing Remitting Multiple Sclerosis | Drug: Teriflunomide | University of Michigan | NULL | Completed | 18 Years | 65 Years | All | 30 | United States | |
| 71 | NCT03266965 (ClinicalTrials.gov) | March 23, 2018 | 4/7/2017 | Histaminergic Basis of Central Fatigue in Multiple Sclerosis - A Novel Approach | Histaminergic Basis of Central Fatigue in Multiple Sclerosis - A Novel Approach | Multiple Sclerosis | Drug: Carbidopa;Dietary Supplement: L-Histidine | University of Miami | United States Department of Defense | Completed | 18 Years | 60 Years | All | 18 | Phase 1 | United States |
| 72 | ChiCTR-DND-17013749 | 2017-12-01 | 2017-12-07 | Application of 3.0 T MRI 3D sequences of CUBE-T2 FLAIR?DIR for brain lesions of childhood-onset multiple sclerosis | Application of 3.0 T MRI 3D sequences of CUBE-T2 FLAIR?DIR for brain lesions of childhood-onset multiple sclerosis | childhood-onset multiple sclerosis | Gold Standard:CUBE-T2 FLAIR scanning;Index test:DIR scanning; | Children's Hospital of Chongqing Medical University | NULL | Recruiting | Both | Target condition:80;Difficult condition:0 | China | |||
| 73 | EUCTR2017-002634-24-SE (EUCTR) | 29/09/2017 | 06/07/2017 | MultipleMS – a study with the aim to accelerate personalised medicine in multiple sclerosis. | MultipleMS – Multiple-omics approach to accelerate personalised medicine in a prospective cohort of newly diagnosed MS and CIS patients. - MultipleMS | Newly diagnosed patients with Clinically Isolated Syndrome (CIS) and multiple sclerosis (MS) -both relapsing remitting and primary progressive);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Gilenya INN or Proposed INN: FINGOLIMOD Other descriptive name: FINGOLIMOD Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Trade Name: Betaferon INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Trade Name: Extavia INN or Proposed INN: INTERFERON BETA-1B Other descriptive name: INTERFERON BETA-1B Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | Sweden | ||
| 74 | NCT03345940 (ClinicalTrials.gov) | April 30, 2017 | 16/5/2017 | Fingolimod Versus Dimethyl-fumarate in Multiple Sclerosis | A Multicentric Randomized PRAGmatic Trial to Compare the Effectiveness of Fingolimod Versus Dimethyl-Fumarate on Patient Overall Disease Experience in Relapsing Remitting Multiple Sclerosis: Novel Data to Inform Decision-makers | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod;Drug: Dimethyl Fumarate | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | Patient-Centered Outcomes Research Institute;Universita degli Studi di Genova | Terminated | 18 Years | N/A | All | 55 | Phase 4 | Italy |
| 75 | NCT03073603 (ClinicalTrials.gov) | April 20, 2017 | 18/1/2017 | Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS) | Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS) | Multiple Sclerosis | Drug: Discontinuation of disease modifying therapy;Drug: Standard of Care | University of Colorado, Denver | Patient-Centered Outcomes Research Institute;National Multiple Sclerosis Society;University of Alabama at Birmingham | Completed | 55 Years | N/A | All | 259 | Phase 4 | United States |
| 76 | NCT02881567 (ClinicalTrials.gov) | April 18, 2017 | 24/8/2016 | Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab | A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab (SUSTAIN) | Relapsing-Remitting Multiple Sclerosis (RRMS) | Drug: Daclizumab | Biogen | AbbVie | Terminated | 18 Years | 55 Years | All | 41 | Phase 3 | United States;Canada;Germany;Italy;Puerto Rico;France;United Kingdom |
| 77 | EUCTR2015-001202-34-IT (EUCTR) | 04/05/2016 | 08/06/2021 | A preliminary, multicenter study on the relationship between cortical damage and blood brain barrier damage in Multiple Sclerosis patients with high cortical disease activity, | A preliminary, multicenter study on the relationship between cortical damage and blood brain barrier damage in Multiple Sclerosis patients with high cortical disease activity. Correlation between [11C]-PK-11195 or [18F]-NAF PET (Positron Emission Tomography) and high field MRI (Magnetic Resonance Imaging): a synergistic effect by using a double-technique approach. - A preliminary, multicenter study on the relationship between cortical damage and blood brain barrier | Multiple Sclerosis MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Na18F Product Code: Na18F Product Name: [11C]-PK-11195 Product Code: [11C]-PK-11195 | AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 18 | Phase 2 | Italy | ||
| 78 | NCT02688985 (ClinicalTrials.gov) | April 29, 2016 | 18/2/2016 | Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS) | An Open-Label, Multicenter, Biomarker Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Patients With Relapsing Multiple Sclerosis or Primary Progressive Multiple Sclerosis | Relapsing Multiple Sclerorsis;Multiple Sclerosis, Primary Progressive | Drug: Ocrelizumab;Procedure: Lumbar Puncture;Drug: Methyloprednisolone;Drug: Antihistamine | Genentech, Inc. | NULL | Active, not recruiting | 18 Years | 55 Years | All | 132 | Phase 3 | United States;Canada;Germany;Sweden |
| 79 | NCT02782858 (ClinicalTrials.gov) | April 2016 | 23/5/2016 | Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS | An International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: GNbAC1;Drug: Placebo | GeNeuro SA | Les Laboratoires Servier (LLS);Institut de Recherches Internationales Servier;Worldwide Clinical Trials | Completed | 18 Years | 55 Years | All | 270 | Phase 2 | Bulgaria;Croatia;Czechia;Estonia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Ukraine |
| 80 | NCT02675413 (ClinicalTrials.gov) | April 2016 | 11/1/2016 | Mechanisms of Action of Dimethyl Fumarate (Tecfidera) in Relapsing MS | Mechanisms of Action of Dimethyl Fumarate in Relapsing MS | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Drug: Dimethyl Fumarate | Washington University School of Medicine | Biogen | Withdrawn | 18 Years | N/A | Both | 0 | Phase 4 | United States |
| 81 | EUCTR2015-000922-12-DE (EUCTR) | 12/02/2016 | 02/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 82 | EUCTR2015-000922-12-FR (EUCTR) | 28/01/2016 | 26/02/2016 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Finland;Spain;Ireland;Turkey;Austria;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany | ||
| 83 | EUCTR2015-000922-12-PL (EUCTR) | 05/01/2016 | 03/12/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany | ||
| 84 | EUCTR2015-000922-12-BE (EUCTR) | 04/01/2016 | 01/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 85 | EUCTR2015-000922-12-IE (EUCTR) | 22/12/2015 | 09/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 86 | EUCTR2015-004116-38-SE (EUCTR) | 18/12/2015 | 20/10/2015 | A clincial study comparing the effectiveness of two drugs, named Rituximab and Dimethyl Fumarate (Tecfidera®), for the neurological disease Multiple Sclerosis. | RItuximab versus FUmarate in Newly Diagnosed Multiple Sclerosis – RIFUND-MSA randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early Relapsing-Remitting Multiple SclerosisObjective: To compare the efficacy of rituximab on the ability to prevent relapses in early RRMS and CIS compared with dimethyl fumarate (DMF), which is an approved first-line medication for RRMS today, using a phase 3 design.Population: Patients with newly diagnosed RRMS or CIS with no more than 10 years disease duration (since diagnosis), 18 – 50 years of age and previously not treated with immunomodulating drugs OR treated with first-line injectables. Patients should display protocol-defined clinical or radiological disease activity during the preceding year before screening for inclusion.Intervention: Treatment with rituximab (Mabthera®) with an initial dose of 1000 mg intravenously (iv) followed by 500 mg iv every six months.Control: Treatment with DMF (Tecfidera®) 240 mg twice daily. The two treatments are randomised in a 1:1 proportion.Outcome: Primary outcome is the relative risk of experiencing a relapse during the two–year period for either compound. As secondary endpoints worsening on neurological disability, magnetic-resonance imaging-defined disease activity and effect on cerebrospinal fluid biomarkers will be analysed. In addition, health-economic evaluations of using rituximab as first-line treatment for RRMS will be performed. | Patients with multiple sclerosis (MS) or patients presenting with symptoms highly suspicious of MS while not completely fulfilling diagnostic criteria, 18 - 50 years of age and no more than 10 years of disease duration (from diagnosis). Patients treated with immunomodulatory drugs or treated with first-line injectable therapies (eg interferons or glatiramer acetate) may be included.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE | Department of Clinical Sciences, Danderyd Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Sweden | ||
| 87 | EUCTR2015-000922-12-FI (EUCTR) | 15/12/2015 | 07/12/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany | ||
| 88 | EUCTR2015-000922-12-HR (EUCTR) | 11/12/2015 | 04/02/2016 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 89 | EUCTR2015-000922-12-AT (EUCTR) | 19/11/2015 | 01/10/2015 | A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily | A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE | Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Copaxone 20 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE Trade Name: Copaxone 40 mg/ml INN or Proposed INN: Not applicable Other descriptive name: GLATIRAMER ACETATE | Teva Pharmaceutical Industries, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 4 | United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany | ||
| 90 | EUCTR2014-004483-38-DE (EUCTR) | 16/07/2015 | 28/04/2015 | TMP001 in relapsing-remitting multiple sclerosis: a multicentre open, baseline-controlled phase IIa clinical trial | TMP001 in relapsing-remitting multiple sclerosis: a multicentre open, baseline-controlled phase IIa clinical trial | Patients with defined diagnosis of relapsing-remitting multiple sclerosis and at least 1 documented relapse during the previous year OR at least 2 documented relapses during the previous 2 years. MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Tarenflurbil Product Code: TMP001 INN or Proposed INN: Tarenflurbil Other descriptive name: FLURBIPROFEN | Fraunhofer Gesellschaft for its Institute Fraunhofer Institute for Molecular Biology and Applied Ecology (IME) | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | Germany | ||
| 91 | JPRN-UMIN000018154 | 2015/07/01 | 01/07/2015 | 11C-acetate PET for Multiple sclerosis | 11C-acetate PET for Multiple sclerosis - 11C-acetate PET for Multiple sclerosis | Multiple Sclerosis, NMO | Withdraw blood before and after the injection of 11C-acetate | department of neurology, Osaka university school of medicine | NULL | Recruiting | 20years-old | 75years-old | Male and Female | 30 | Not applicable | Japan |
| 92 | NCT02665221 (ClinicalTrials.gov) | July 2015 | 22/1/2016 | Single Center, Open Label, Study of Preparation H on Erythema in Relapsing MS Patients Treated With PLEGRIDY | Single Center, Randomized, Open Label Study in Relapsing MS Patients on PLEGRIDY to Assess Topical Application of Preparation H (Phenylephrine) on Mitigation of Erythema Severity and Size. | Multiple Sclerosis | Other: No Treatment Arm;Drug: Topical Preparation H arm | New York University School of Medicine | NULL | Terminated | 18 Years | 70 Years | All | 32 | Phase 4 | United States |
| 93 | NCT02423083 (ClinicalTrials.gov) | April 21, 2015 | 21/4/2015 | Oral Guanabenz for Multiple Sclerosis | Phase I Study of Oral Guanabenz for Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis | Drug: Guanabenz | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Terminated | 18 Years | 55 Years | All | 2 | Phase 1 | United States |
| 94 | NCT04928313 (ClinicalTrials.gov) | April 12, 2015 | 14/4/2021 | Safety and Effectiveness of Cinnomer® (Glatiramer Acetate) in Multiple Sclerosis (MS) Treatment in Iran | A Phase IV, Post-marketing, Prospective, Multicenter Study to Investigate the Safety and Effectiveness of Cinnomer® (Glatiramer-Acetate) in Multiple Sclerosis (MS) Treatment in Iran | Relapsing Multiple Sclerosis | Drug: Glatiramer Acetate | Cinnagen | NULL | Completed | 18 Years | 60 Years | All | 368 | Phase 4 | NULL |
| 95 | NCT02391961 (ClinicalTrials.gov) | April 1, 2015 | 3/3/2015 | Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple Sclerosis | Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple Sclerosis | Multiple Sclerosis;Internuclear Ophthalmoplegia;Fatigue | Drug: Dalfampridine;Drug: Placebo | VA Office of Research and Development | NULL | Completed | 18 Years | 65 Years | All | 23 | Phase 2 | United States |
| 96 | NCT02200770 (ClinicalTrials.gov) | April 1, 2015 | 16/7/2014 | N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders | A Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | Drug: Inebilizumab;Other: Placebo | MedImmune LLC | NULL | Completed | 18 Years | N/A | All | 231 | Phase 2/Phase 3 | United States;Australia;Bulgaria;Canada;Colombia;Czechia;Estonia;Germany;Hong Kong;Hungary;Israel;Japan;Korea, Republic of;Mexico;Moldova, Republic of;New Zealand;Peru;Poland;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Turkey;China;Czech Republic;Greece;India;Netherlands;Portugal;Ukraine |
| 97 | NCT02939079 (ClinicalTrials.gov) | April 2015 | 14/10/2016 | Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients | Evaluating the Effect of Fingolimod With Fish Oil Compared to Fingolimod With Placebo on Tumor Necrosis Factor-a , Interleukin1b , Interleukin6, and Interferon-gamma in Patients With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Fingolimod;Dietary Supplement: Fish Oil;Drug: Placebo (for Fish Oil) | Isfahan University of Medical Sciences | Shiraz University of Medical Sciences | Completed | 18 Years | 45 Years | All | 50 | Phase 2/Phase 3 | NULL |
| 98 | NCT02428231 (ClinicalTrials.gov) | April 2015 | 23/4/2015 | Tecfidera Slow-Titration Study | A Multicenter, Treatment-Blind Phase 3b Study to Evaluate Whether 6-Week Up-Titration in Tecfidera® Dose is Effective in Reducing the Incidence of Gastrointestinal Adverse Events in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: dimethyl fumarate | Biogen | NULL | Terminated | 18 Years | 65 Years | All | 62 | Phase 3 | United States;Belgium;Czech Republic;Italy;Australia;Canada;France;Germany;Hungary;Spain |
| 99 | NCT02398461 (ClinicalTrials.gov) | April 2015 | 13/3/2015 | An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse | A Double-Blind, Placebo-Controlled, Single Ascending Dose Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse | Multiple Sclerosis, Acute Relapsing | Drug: rHIgM22;Drug: Placebo | Acorda Therapeutics | PRA Health Sciences | Completed | 18 Years | 70 Years | All | 27 | Phase 1 | United States |
| 100 | EUCTR2013-002378-26-SE (EUCTR) | 13/11/2014 | 15/08/2013 | Switch To RItuXimab in MS extensionAn extension study of an ongoing clinical trial where people with multiple sclerosis switch therapy from interferon or glatiramere injections to rituximab, a monoclonal antibody that eliminate B lymphocytes | Switch To RItuXimab in MS extensionAn extension study of STRIX-MS - a phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MSext | The original trial (EudraCT 2010-023021-38) recruited 74 patients with relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate. This extension study involves the same patients, those that consent to participate in this extension trial. MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera® Product Name: Mabthera | Västerbottens Läns Landsting | NULL | Not Recruiting | Female: yes Male: yes | 74 | Phase 2 | Sweden | ||
| 101 | EUCTR2013-003126-83-DE (EUCTR) | 23/06/2014 | 17/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Peru;Denmark;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 102 | EUCTR2013-003126-83-GR (EUCTR) | 27/05/2014 | 25/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Denmark;Peru;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 103 | EUCTR2013-002351-15-ES (EUCTR) | 26/05/2014 | 25/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-?-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-?-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | Serbia;Portugal;Belarus;United States;United Arab Emirates;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Peru;Denmark;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden | ||
| 104 | EUCTR2013-003126-83-ES (EUCTR) | 26/05/2014 | 05/03/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-?-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-?-1a in patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | Serbia;Belarus;United States;United Arab Emirates;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Denmark;South Africa;Netherlands;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 105 | EUCTR2013-002351-15-BG (EUCTR) | 21/05/2014 | 20/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Interferon-ß-1a Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden | ||
| 106 | EUCTR2013-003126-83-HU (EUCTR) | 21/05/2014 | 21/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Denmark;Peru;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 107 | EUCTR2013-002351-15-HU (EUCTR) | 21/05/2014 | 21/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden | ||
| 108 | EUCTR2013-002351-15-PT (EUCTR) | 09/05/2014 | 25/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Belarus;Portugal;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden | ||
| 109 | NCT02579681 (ClinicalTrials.gov) | April 30, 2014 | 16/10/2015 | Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012 | Single Country Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis Patients Treated With BG00012 | Multiple Sclerosis, Relapsing-Remitting | Drug: dimethyl fumarate | Biogen | NULL | Completed | 18 Years | N/A | All | 221 | Phase 3 | Italy |
| 110 | EUCTR2013-003126-83-BG (EUCTR) | 16/04/2014 | 20/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Interferon-ß-1a Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Belarus;Serbia;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Peru;Denmark;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 111 | NCT01892345 (ClinicalTrials.gov) | April 11, 2014 | 20/6/2013 | A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study) | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO) | Neuromyelitis Optica;Neuromyelitis Optica Spectrum Disorder | Drug: Eculizumab;Drug: Placebo | Alexion Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 143 | Phase 3 | United States;Argentina;Australia;Croatia;Czechia;Denmark;Germany;Hong Kong;Italy;Japan;Korea, Republic of;Malaysia;Russian Federation;Spain;Taiwan;Thailand;Turkey;United Kingdom;Austria;Canada;Colombia;Czech Republic;France;Singapore |
| 112 | NCT02865018 (ClinicalTrials.gov) | April 2014 | 9/8/2016 | Neuromyelitis Optica (NMO) & Cetirizine | An Open Label, add-on Trial of Cetirizine for Patients With Neuromyelitis Optica | Neuromyelitis Optica | Drug: cetirizine | Icahn School of Medicine at Mount Sinai | Guthy Jackson Foundation | Completed | 18 Years | 85 Years | Both | 16 | Phase 1/Phase 2 | United States |
| 113 | NCT01933802 (ClinicalTrials.gov) | April 2014 | 23/8/2013 | Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Patients With Multiple Sclerosis | Phase 1 Safety Study of Autologous Bone Marrow-derived Mesenchymal Stem Cell-derived Neural Progenitor Cells (MSC-NP), Expanded Ex Vivo, Administered Intrathecally in Patients With Multiple Sclerosis | Multiple Sclerosis | Biological: intrathecal administration of autologous MSC-NP | Tisch Multiple Sclerosis Research Center of New York | NULL | Completed | 18 Years | 70 Years | All | 20 | Phase 1 | United States |
| 114 | NCT04256252 (ClinicalTrials.gov) | April 2014 | 2/2/2020 | Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE) | Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE): a Prospective, Multicenter, Open-label, Follow-up Clinical Trial | Neuromyelitis Optica Spectrum Disorder | Drug: Rituximab | Tang-Du Hospital | NULL | Completed | 16 Years | 75 Years | All | 108 | Phase 4 | NULL |
| 115 | NCT01973517 (ClinicalTrials.gov) | April 2014 | 16/10/2013 | High-Field MRI Iron-Based Contrast-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases | 7T MRI Ferumoxytol-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases | Multiple Sclerosis | Drug: Feraheme;Drug: Gadolinium-based contrast | Stanford University | NULL | Withdrawn | 18 Years | N/A | All | 0 | United States | |
| 116 | EUCTR2013-002351-15-AT (EUCTR) | 13/03/2014 | 28/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden | ||
| 117 | EUCTR2013-002351-15-EE (EUCTR) | 13/03/2014 | 18/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden | ||
| 118 | EUCTR2013-002351-15-LV (EUCTR) | 03/03/2014 | 20/02/2014 | Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. | A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifimod Other descriptive name: ONO-4641 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A Product Code: MSC2430913A or ONO-4641 (to be used as synonyms) INN or Proposed INN: Ceralifmod Other descriptive name: ONO-4641 | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 1176 | Phase 3 | United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden | ||
| 119 | JPRN-UMIN000012705 | 2014/01/07 | 07/01/2014 | The efficacy and safety of an anti-interluekin-6 receptor antibody in relapsing-remitting multiple sclerosis | The efficacy and safety of an anti-interluekin-6 receptor antibody in relapsing-remitting multiple sclerosis - Treatment with an anti-interleukin-6 receptor antibody for relapsing-remitting multiple sclerosis | Relapsing-remitting multiple sclerosis | Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 2 years. | Department of Immunology, National Institute of Neuroscience, NCNP | NULL | Recruiting | 20years-old | 65years-old | Male and Female | 10 | Not applicable | Japan |
| 120 | EUCTR2012-004165-41-GB (EUCTR) | 04/11/2013 | 19/09/2013 | Hematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study | Hematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - Hematopoietic Stem Cell Therapy for Inflammatory MS | Inflammatory Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Tysabri Product Name: Tysabri INN or Proposed INN: natalizumab Trade Name: Fingolimod Product Name: Gilenya INN or Proposed INN: Fingolimod Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG-12 120 INN or Proposed INN: dimethyl fumarate | Northwestern University | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 2 | United States;United Kingdom | ||
| 121 | NCT03133403 (ClinicalTrials.gov) | November 2013 | 21/4/2016 | Hematopoietic Stem Cell Therapy for Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy | Hematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Drug: Tecfidera (BG12);Drug: Gilenya;Drug: Tysabri®;Drug: Avonex/Betaseron/Copaxone/Rebif;Procedure: Hematopoietic stem cell transplantation (HSCT) | Sheffield Teaching Hospitals NHS Foundation Trust | NULL | Recruiting | 18 Years | 55 Years | All | 5 | Phase 2/Phase 3 | United Kingdom |
| 122 | JPRN-UMIN000011111 | 2013/07/16 | 15/07/2013 | Spinal blood flow and metabolism in neurological diseases | Spinal blood flow and metabolism in neurological diseases - Spinal blood flow and metabolism in neurological diseases | motor neuron disease including ALS, multiple sclerosis, stroke, Parkinson disease, spinocerebellar degeneration, multiple system atrophy | PET scan study with 11C-flumazenil PET scan study with 18F- FDG PET scan study with 15O-H2O | Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 70 | Not applicable | Japan |
| 123 | NCT03198351 (ClinicalTrials.gov) | April 25, 2013 | 22/6/2017 | An Observational Study on Teriflunomide-exposed Pregnancies | Teriflunomide Pregnancy Outcome Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy Project | Multiple Sclerosis | Drug: Teriflunomide (HMR1726) | Sanofi | NULL | Recruiting | 16 Years | N/A | Female | 325 | United States;Canada | |
| 124 | NCT01888354 (ClinicalTrials.gov) | April 2013 | 16/5/2013 | Pilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous (SQ)Versus ACTHar Gel Five Days SQ for the Treatment of MS Exacerbations | Pilot Clinical Trial of ACTHar Gel 14 Days Subcutaneous (SQ) Versus ACTHar Gel Five Days SQ for the Treatment of MS Exacerbations | Multiple Sclerosis (MS) | Drug: H.P. Acthar Gel (repository corticotropin injection) | The University of Texas Health Science Center, Houston | NULL | Completed | 18 Years | 55 Years | Both | 25 | Phase 4 | United States |
| 125 | NCT01767701 (ClinicalTrials.gov) | April 2013 | 7/1/2013 | Raltegravir (Isentress) Pilot Study in Relapsing Multiple Sclerosis | A Phase II Baseline Versus Treatment Study to Determine the Efficacy of Raltegravir (Isentress) in Preventing Progression of Relapsing Remitting Multiple Sclerosis as Determined by Gadolinium-enhanced MRI | Relapsing Remitting Multiple Sclerosis | Drug: Raltegravir | Queen Mary University of London | Merck Sharp & Dohme Corp. | Completed | 18 Years | 55 Years | All | 23 | Phase 2 | United Kingdom |
| 126 | NCT01738347 (ClinicalTrials.gov) | April 2013 | 13/11/2012 | Assess Safety, Bio-distribution, Radiation Dosimetry and Optimize the Imaging Protocol of GEH120714 (18F) Injection in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS). | Assess Safety, Bio-distribution, and Radiation Dosimetry, and Optimize the Imaging Protocol of GEH120714 (18F) Injection, a Marker of Microglial Activation, in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS) | Relapsing-remitting Multiple Sclerosis (rrMS) | Drug: Arm 1 - GEH120714 (18F) Injection | GE Healthcare | Centre for Probe Development and Commercialization | Completed | 20 Years | 50 Years | All | 30 | Phase 1 | Canada;United States |
| 127 | NCT01844232 (ClinicalTrials.gov) | April 2013 | 24/4/2013 | One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With Spasticity | A One Year, Open Label, Dose Escalation Study To Evaluate the Long-Term Safety of Arbaclofen Extended Release Tablets (AERT) in Multiple Sclerosis Subjects With Spasticity | Multiple Sclerosis;Spasticity | Drug: arbaclofen | RVL Pharmaceuticals, Inc. | Osmotica Pharmaceutical US LLC | Completed | 18 Years | 70 Years | All | 150 | Phase 3 | United States;Russian Federation;Ukraine |
| 128 | NCT01808885 (ClinicalTrials.gov) | April 2013 | 12/2/2013 | Safety Study of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta. | A 24-Week, Ph1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study, to Assess the Safety Profile of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta. | Relapsing Remitting Multiple Sclerosis | Drug: olesoxime (TRO19622);Drug: placebo | Hoffmann-La Roche | Hôpital de la Timone;SGS S.A.;STRAGEN Services | Completed | 18 Years | N/A | Both | 44 | Phase 1 | France |
| 129 | EUCTR2012-003418-15-AT (EUCTR) | 23/10/2012 | 09/11/2012 | Methylphenidate modified release as treatment of MS-associated fatigue. | Methylphenidate modified release as treatment option of MS-associated fatigue. A single-center randomized double-blind placebo-controlled trial. | Fatigue is a very common symptom in multiple sclerosis. Its management comprises nonpharmacologic approaches like exercise, cooling procedures and energy conservation programs and as second step pharmacologic therapy. Until now, Amantadine, Modafinil or antidepressants have been used off-label among others, with some success. Until now, methylphenidate has been successfully used to treat fatigue in HIVand parkinson´s disease, data on its efficacy in MS are not available.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ritalin LA 20mg capsules Product Name: Methylphenidate modified release 20 mg INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE Trade Name: Ritalin LA 30mg capsules Product Name: Methylphenidate modified release 30 mg INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE Trade Name: Ritalin LA 40mg capsules Product Name: Methylphenidate modified release 40 mg INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE | Medizinische Universität Wien | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | Austria | ||
| 130 | EUCTR2009-017978-21-PL (EUCTR) | 17/08/2012 | 06/03/2012 | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | United States;United Arab Emirates;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Tunisia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden | ||
| 131 | EUCTR2009-017978-21-PT (EUCTR) | 06/07/2012 | 11/08/2011 | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | United States;United Arab Emirates;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Tunisia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden | ||
| 132 | JPRN-UMIN000009421 | 2012/06/28 | 28/11/2012 | Efficacy and safety of rituximab for intractable immunogenic neurological disorder in children | Efficacy and safety of rituximab for intractable immunogenic neurological disorder in children - rituximab for pediatric neurological disorder | neuromyelitis optica (NMO), opsoclonus-myoclonus syndrome (OMS) | administration of rituximab | Department of Pediatrics, Kobe Universtiy Graduate School of Medicine | NULL | Recruiting | Not applicable | 18years-old | Male and Female | 10 | Not applicable | Japan |
| 133 | NCT01623596 (ClinicalTrials.gov) | June 8, 2012 | 18/6/2012 | Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis. | A 12-month, Prospective, Randomized, Active-controlled, Open-label Study to Evaluate the Patient Retention of Fingolimod vs. Approved First-line Disease Modifying Therapies in Adults With Relapsing Remitting Multiple Sclerosis (PREFERMS) | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod;Drug: Disease Modifying therapy | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 65 Years | All | 881 | Phase 4 | United States;Puerto Rico |
| 134 | JPRN-UMIN000007866 | 2012/05/01 | 01/05/2012 | The safety and efficacy of tocilizumab in patients with neuromyelitis optica: Multicenter Study | The safety and efficacy of tocilizumab in patients with neuromyelitis optica: Multicenter Study - Tocilizumab in patients with neuromyelitis optica: Multicenter Study | neuromyelitis optica | Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 years. | Department of Immunology, National Institute of Neuroscience, NCNP | Department of Neurology, Kinki University Faculty of Mediceine | Complete: follow-up continuing | 20years-old | 65years-old | Male and Female | 15 | Not applicable | Japan |
| 135 | NCT01491100 (ClinicalTrials.gov) | April 30, 2012 | 12/12/2011 | Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple Sclerosis | Study Assessing Cognitive Performance Plus Physical Activity in Patients With Relapsing-Remitting MS Under Treatment With Betaferon® | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 12 Years | 70 Years | All | 1085 | Albania;Algeria;Argentina;Belgium;Czechia;Egypt;France;Germany;Greece;Hungary;Israel;Kazakhstan;Netherlands;Portugal;Saudi Arabia;Tunisia;Turkey;Bosnia and Herzegovina;Czech Republic;Jordan;Lebanon;Mexico;Poland;Syrian Arab Republic | |
| 136 | NCT01514370 (ClinicalTrials.gov) | April 30, 2012 | 17/1/2012 | Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1a | ProspeCtive Study to Evaluate Efficacy, Safety and tOlerability of Dietary supplemeNT of Curcumin (BCM95) in Subjects With Active Relapsing MultIple Sclerosis Treated With subcutaNeous Interferon Beta 1a 44 mcg Three Times a Week (TIW) | Multiple Sclerosis | Drug: IFN beta 1a 44 mcg TIW;Drug: Curcumin;Drug: Placebo | Merck KGaA, Darmstadt, Germany | Merck Serono S.P.A., Italy | Completed | 18 Years | 60 Years | All | 80 | Phase 2 | Italy |
| 137 | NCT01585298 (ClinicalTrials.gov) | April 29, 2012 | 23/4/2012 | STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START) | A 1-week, Open-label, Multi-center Study to Explore Conduction Abnormalities During First Dose Administration of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: FTY720 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 6998 | Phase 4 | Germany |
| 138 | NCT01585766 (ClinicalTrials.gov) | April 24, 2012 | 9/4/2012 | Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis | A Phase 1 Randomized Study of MEDI-551 in Subjects With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis, Relapsing Forms | Drug: MEDI-551 30 MG-IV;Drug: MEDI-551 60 MG-SC;Drug: PLACEBO-IV-SC;Drug: MEDI-551 100 MG-IV;Drug: MEDI-551 300 MG-SC;Drug: MEDI-551 600 MG-IV | MedImmune LLC | NULL | Completed | 18 Years | 65 Years | All | 56 | Phase 1 | United States;Poland;Spain;Ukraine;Czech Republic;United Kingdom |
| 139 | NCT01480063 (ClinicalTrials.gov) | April 16, 2012 | 23/11/2011 | An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice | A Multicenter, Multinational, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra® When Used In Routine Medical Practice (LIBERATE) | Multiple Sclerosis | Drug: Fampridine | Biogen | NULL | Completed | N/A | N/A | All | 4734 | Argentina;Canada;Czechia;France;Germany;Ireland;Israel;Lebanon;Netherlands;Norway;Portugal;Spain;United Arab Emirates;Australia;Belgium;Czech Republic;Denmark | |
| 140 | NCT01627938 (ClinicalTrials.gov) | April 2012 | 30/5/2012 | Study to Evaluate the Reduction of Cardiac Problems in Multiple Sclerosis Patients With Mitoxantrone and Dexrazoxane in Combination | A Phase II Proof of Concept Study Evaluating the Reduction of Mitoxantrone-induced Cardiotoxicity and Neurological Outcome in the Combined Use of Mitoxantrone and Dexrazoxane (Cardioxane®) in Multiple Sclerosis (MSCardioPro) | Multiple Sclerosis | Drug: Dexrazoxane (DRZ) plus Mitoxantrone (MX);Drug: Placebo plus Mitoxantrone (MX) | PD Dr. Andrew Chan | NULL | Active, not recruiting | 18 Years | 55 Years | Both | 50 | Phase 2 | Germany |
| 141 | NCT01538225 (ClinicalTrials.gov) | April 2012 | 20/2/2012 | Neurophysiological Study of Sativex in Multiple Sclerosis (MS) Spasticity | Neurophysiologic Study on Effects of Sativex® on Spasticity in Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: Sativex®;Drug: Placebo | Almirall, S.A. | NULL | Completed | 18 Years | N/A | Both | 45 | Phase 3 | Italy |
| 142 | EUCTR2009-017978-21-GR (EUCTR) | 17/01/2012 | 08/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | Serbia;Portugal;United Arab Emirates;United States;Estonia;Saudi Arabia;Taiwan;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Netherlands;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 143 | NCT01500408 (ClinicalTrials.gov) | January 2012 | 22/12/2011 | Demonstrate the Bioequivalence of Interferon Beta-1a (INFB) Manufactured by Two Different Processes in Healthy Volunteers | A Randomized, Single-Blind, Crossover Study in Healthy Volunteers to Demonstrate the Bioequivalence of Interferon Beta-1a Manufactured by Two Different Processes | Multiple Sclerosis | Drug: Interferon beta-1a (current approved manufacturing process invloving FBS);Drug: Interferon beta-1a (new process, manufactured without FBS) | Biogen Idec | NULL | Completed | 18 Years | 45 Years | Both | 110 | Phase 1 | United States |
| 144 | NCT02280876 (ClinicalTrials.gov) | January 2012 | 20/10/2014 | Efficacy Study of Andrographis Paniculata Purified Standardized Extract (ApE) in Patients With Multiple Sclerosis (MS) | Randomized, Comparative, Double Blind Controlled Phase II Clinical Trial, to Evaluate the Efficacy of ApE in Patients With Multiple Sclerosis (MS). | Multiple Sclerosis, Relapsing-Remitting | Drug: 1 - Andrographis paniculata p/st extract;Drug: 2 - Excipients | Universidad Austral de Chile | Comisión Nacional de Investigación Científica y Tecnológica;University of Chile | Completed | 18 Years | 55 Years | Both | 30 | Phase 1/Phase 2 | Chile |
| 145 | EUCTR2010-021219-17-DE (EUCTR) | 31/10/2011 | 05/07/2011 | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis | A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis - Not applicable | Primary progressive or relapse-free secondary progressive multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate INN or Proposed INN: masitinb mesylate Product Name: mastinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate INN or Proposed INN: masitinb mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Morocco;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Romania;South Africa;Bulgaria;Germany;Tunisia;Bosnia and Herzegovina | ||
| 146 | EUCTR2009-017978-21-DK (EUCTR) | 21/09/2011 | 12/09/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 147 | NCT01442194 (ClinicalTrials.gov) | August 1, 2011 | 21/8/2011 | Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies | Long-term, Prospective,Multinational, Parallel-cohort Study Monitoring Safety in Patients With MS Newly Started With Fingolimod Once Daily or Treated With Another Approved Disease-modifying Therapy | Multiple Sclerosis | Drug: other disease-modifying therapy;Drug: Fingolimod | Novartis Pharmaceuticals | NULL | Completed | N/A | N/A | All | 3076 | United States;Argentina;Australia;Canada;Chile;Mexico;Puerto Rico | |
| 148 | EUCTR2009-017978-21-LT (EUCTR) | 25/07/2011 | 30/03/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | |||
| 149 | EUCTR2009-017978-21-ES (EUCTR) | 13/07/2011 | 17/11/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry | Pacientes con esclerosis múltiple que hayan participado en estudios con cladribina. MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2?-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 150 | EUCTR2009-017978-21-BE (EUCTR) | 12/07/2011 | 29/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;United Arab Emirates;Portugal;Serbia;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Netherlands;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 151 | JPRN-UMIN000005889 | 2011/07/01 | 08/07/2011 | The safety and efficacy of tocilizumab in patients with neuromyelitis optica | The safety and efficacy of tocilizumab in patients with neuromyelitis optica - Tocilizumab in patients with neuromyelitis optica | neuromyelitis optica | Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 months. | Department of Immunology, National Institute of Neuroscience, NCNP | NULL | Complete: follow-up complete | 20years-old | 65years-old | Male and Female | 3 | Not applicable | Japan |
| 152 | EUCTR2009-017978-21-SE (EUCTR) | 08/06/2011 | 03/05/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 153 | EUCTR2009-017978-21-CZ (EUCTR) | 06/06/2011 | 11/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 15.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2175 | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | |||
| 154 | EUCTR2009-017978-21-GB (EUCTR) | 03/06/2011 | 11/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | United States;United Arab Emirates;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Tunisia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden | ||
| 155 | EUCTR2009-017978-21-LV (EUCTR) | 06/05/2011 | 18/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 15.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 156 | EUCTR2009-017978-21-AT (EUCTR) | 05/05/2011 | 31/03/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 157 | EUCTR2009-017978-21-EE (EUCTR) | 21/04/2011 | 13/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United Arab Emirates;United States;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 158 | EUCTR2011-000770-60-IT (EUCTR) | 12/04/2011 | 01/09/2011 | An open-label, multi-center, expanded access study with fingolimod in patients with relapsing-remitting multiple sclerosis for whom no suitable therapy exists” - ND | An open-label, multi-center, expanded access study with fingolimod in patients with relapsing-remitting multiple sclerosis for whom no suitable therapy exists” - ND | approximately 600 patients with relapsing-remitting MS for whom no suitable therapy exists i.e. where existing therapies have failed. MedDRA version: 14.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: fingolimod Product Code: FTY720D INN or Proposed INN: other nervous system drugs | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 600 | Italy | |||
| 159 | NCT01407211 (ClinicalTrials.gov) | April 2011 | 14/2/2011 | Impact of Vitamin A on Gene Expression, in Multiple Sclerosis Patient | The Impact of Vitamin A Supplementation on Gene Expression of Cytokine Secreted by CD4+ T Lymphocyte in Multiple Sclerosis Patients | Relapsing Remitting Multiple Sclerosis | Dietary Supplement: vitamin A | Tehran University of Medical Sciences | NULL | Enrolling by invitation | 20 Years | 45 Years | Both | 30 | Phase 4 | Iran, Islamic Republic of |
| 160 | NCT01332019 (ClinicalTrials.gov) | April 2011 | 24/3/2011 | Long-Term Safety and Efficacy Study of Peginterferon Beta-1a | A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: peginterferon beta-1a | Biogen | NULL | Completed | 18 Years | 65 Years | All | 1077 | Phase 3 | United States;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Estonia;France;Georgia;Germany;Greece;India;Latvia;Mexico;Netherlands;New Zealand;Peru;Poland;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom |
| 161 | NCT01305837 (ClinicalTrials.gov) | April 2011 | 28/2/2011 | Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis | Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis | Progressive Multiple Sclerosis | Drug: methylprednisolone | Rigshospitalet, Denmark | NULL | Completed | 18 Years | 65 Years | Both | 30 | Phase 2 | Denmark |
| 162 | EUCTR2010-023560-40-SE (EUCTR) | 23/03/2011 | 21/12/2010 | Blood stem cell transplantation for patients with relapsiong-remitting multiple sclerosis, in whom standard treatment has failed. | Haematopoetic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - MIST | Relapsing-remitting multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Sendoxan Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE Trade Name: Thymoglobuline Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN Trade Name: Neupogen Trade Name: Solu-Medrol | Uppsala l?ns landsting | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | United States;Canada;Brazil;Sweden | |||
| 163 | EUCTR2010-023021-38-SE (EUCTR) | 23/02/2011 | 26/11/2010 | Switch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MS | Switch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MS | Relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Mabthera INN or Proposed INN: RITUXIMAB | Västerbottens läns landsting | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Sweden | |||
| 164 | EUCTR2009-017978-21-BG (EUCTR) | 08/02/2011 | 11/09/2015 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 18.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 165 | EUCTR2009-017978-21-DE (EUCTR) | 20/12/2010 | 22/11/2010 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 166 | NCT01181115 (ClinicalTrials.gov) | April 2010 | 5/8/2010 | Avonex Safety and Tolerability in Chinese Subjects With Relapsing Multiple Sclerosis (MS) | An Open-Label Study to Evaluate the Safety and Tolerability and to Explore the Efficacy of Avonex (Interferon Beta-1a) in Chinese Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Avonex | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 60 | Phase 3 | China |
| 167 | NCT01071512 (ClinicalTrials.gov) | April 2010 | 17/2/2010 | Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis | Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis | Multiple Sclerosis | Drug: Tysabri | University of Chicago | Biogen | Completed | 18 Years | 60 Years | All | 20 | N/A | United States |
| 168 | NCT01097668 (ClinicalTrials.gov) | March 2010 | 31/3/2010 | ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis | SAFETY AND PROOF OF PRINCIPLE STUDY OF ATX-MS-1467 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS: OPEN LABEL UPWARD TITRATION OVER FIVE DOSE LEVELS AND USING TWO ROUTES OF ADMINISTRATION (INTRADERMAL AND SUBCUTANEOUS). | Relapsing Remitting Multiple Sclerosis | Biological: ATX-MS-1467 | Apitope Technology (Bristol) Ltd. | Aptiv Solutions;ClinStar, LLC | Completed | 18 Years | 55 Years | All | 43 | Phase 1 | Russian Federation;United Kingdom |
| 169 | NCT01077466 (ClinicalTrials.gov) | March 2010 | 26/2/2010 | Natalizumab Treatment of Progressive Multiple Sclerosis | Natalizumab Treatment of Progressive Multiple Sclerosis | Primary Progressive Multiple Sclerosis;Secondary Progressive Multiple Sclerosis | Drug: Natalizumab | Rigshospitalet, Denmark | Copenhagen University Hospital, Hvidovre;Biogen Idec;University of Copenhagen;Signifikans ApS | Completed | 19 Years | 55 Years | Both | 24 | Phase 2 | Denmark |
| 170 | EUCTR2009-012431-15-CZ (EUCTR) | 21/01/2010 | 02/12/2009 | Možnosti terapeutického ovlivnení neurogenního hyperaktivního detruzoru u pacientu po spinálním poranení a s roztroušenou sklerózou aplikací botulinumtoxinu A. Prospektivní, otevrená studie porovnávající efekt aplikace 300 U Botoxu® pri podání do detruzoru mocového mechýre a subsliznicního podání.Therapeutic Use of Botulinum-A toxin in Neurogenic Detrusor Overactivity in Patient after Spinal Cord Injury and Multiple Sclerosis. A Prospective, Open Study with Comparison of Suburothelial and Intradetrusor Application of 300 U of Botox®. | Možnosti terapeutického ovlivnení neurogenního hyperaktivního detruzoru u pacientu po spinálním poranení a s roztroušenou sklerózou aplikací botulinumtoxinu A. Prospektivní, otevrená studie porovnávající efekt aplikace 300 U Botoxu® pri podání do detruzoru mocového mechýre a subsliznicního podání.Therapeutic Use of Botulinum-A toxin in Neurogenic Detrusor Overactivity in Patient after Spinal Cord Injury and Multiple Sclerosis. A Prospective, Open Study with Comparison of Suburothelial and Intradetrusor Application of 300 U of Botox®. | Studie se zabývá lécbou hyperaktivního neurogeního detruzoru u pacientu, kterí trpí príznaky hyperaktivního mocového mechýre jako dusledek spinálního poranení nebo roztroušené sklerózy. K lécbe se pužívá botulinumotoxin. Ve studii se porovnávaní dve ruzné formy aplikace studjiního léku. | Trade Name: Botox Other descriptive name: BOTULINUM TOXIN TYPE A | Krajská nemocnice Liberec, a.s. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Czech Republic | |||
| 171 | NCT00883337 (ClinicalTrials.gov) | April 2009 | 16/4/2009 | A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Multi-center, Randomized, Parallel-group, Rater-blinded Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis Plus a Long Term Extension Period | Multiple Sclerosis | Drug: Interferon ß-1a;Drug: Teriflunomide | Sanofi | NULL | Completed | 18 Years | N/A | All | 324 | Phase 3 | Belgium;Canada;Czech Republic;France;Germany;Greece;Hungary;Italy;Poland;Spain;Switzerland;Tunisia;United Kingdom |
| 172 | NCT00904826 (ClinicalTrials.gov) | April 2009 | 18/5/2009 | An Open Label Study of the Effects of Eculizumab in Neuromyelitis Optica | An Open Label Study of the Effects of Eculizumab in Neuromyelitis Optica | Neuromyelitis Optica;Devic's Disease | Drug: Eculizumab | Mayo Clinic | Alexion Pharmaceuticals | Completed | 18 Years | N/A | All | 14 | Phase 1/Phase 2 | United States |
| 173 | NCT00764413 (ClinicalTrials.gov) | April 2009 | 1/10/2008 | Chronotherapy in Acute Multiple Sclerosis (MS) Attack | Treatment With Methylprednisolone in Acute Exacerbations of Multiple Sclerosis: Enhanced Effect With Nighttime Treatment? | Multiple Sclerosis | Drug: methylprednisolone;Drug: Sodium chlorid | Sykehuset Innlandet HF | NULL | Terminated | 18 Years | N/A | Both | 57 | N/A | Norway |
| 174 | NCT00881205 (ClinicalTrials.gov) | April 2009 | 14/4/2009 | Rivastigmine in Multiple Sclerosis Patients With Cognitive Impairment | A 16-week, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Rivastigmine Patch (10 cm²) on Cognitive Deficits in Patients With Multiple Sclerosis, Followed by a 1-year Open-label Treatment Phase | Multiple Sclerosis;Cognitive Impairment | Drug: Rivastigmine transdermal patch;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 65 Years | All | 86 | Phase 4 | Germany |
| 175 | NCT00914290 (ClinicalTrials.gov) | April 2009 | 2/6/2009 | A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis | A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis | Spasticity;Multiple Sclerosis | Drug: IPX056;Drug: Baclofen IR;Drug: Placebo IPX056;Drug: Placebo IR | Impax Laboratories, LLC | NULL | Completed | 18 Years | N/A | All | 23 | Phase 2 | United States |
| 176 | NCT00882999 (ClinicalTrials.gov) | April 2009 | 16/4/2009 | A Study of Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) | Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: LY2127399;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 18 Years | 64 Years | All | 245 | Phase 2 | United States;Bulgaria;Czechia;France;Germany;Hungary;Israel;Poland;Romania;Russian Federation;Serbia;Slovakia;Ukraine;Belgium;Canada;Czech Republic;Denmark;Finland;Switzerland |
| 177 | EUCTR2008-004174-40-FR (EUCTR) | 06/03/2009 | 25/11/2008 | Imagerie de la démyélinisation dans la sclérose en plaques : une étude en tomographie à émission de positons (TEP) avec le 11C-2-(4'-methylaminophenyl)-6-hydroxybenzothiazole (11C-PIB) - SHADOWTEP | Imagerie de la démyélinisation dans la sclérose en plaques : une étude en tomographie à émission de positons (TEP) avec le 11C-2-(4'-methylaminophenyl)-6-hydroxybenzothiazole (11C-PIB) - SHADOWTEP | Groupe I: volontaires sainsGroupe II: patients avec une sclérose en plaques d'évolution rémittente . MedDRA version: 8.1;Level: PT;Classification code 10012300;Term: Demyelinating disease (excl multiple sclerosis) | Product Name: 11C-PIB INN or Proposed INN: 11C-PIB | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 178 | EUCTR2007-000381-20-BG (EUCTR) | 28/10/2008 | 20/10/2008 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Germany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon | ||
| 179 | EUCTR2007-000381-20-GR (EUCTR) | 09/09/2008 | 01/04/2008 | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Czech Republic;Denmark;Estonia;Greece;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom | |||
| 180 | EUCTR2007-000381-20-NL (EUCTR) | 29/08/2008 | 01/02/2008 | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece | |||
| 181 | EUCTR2007-006338-32-ES (EUCTR) | 16/07/2008 | 28/03/2008 | Estudio en fase II de búsqueda de dosis, multicéntrico, aleatorio, de grupos paralelos, parcialmente enmascarado, con placebo y Avonex® como fármacos control, para evaluar la eficacia, determinada por las lesiones cerebrales que aparecen en la RMN y la seguridad de dos pautas terapéuticas de ocrelizumab en pacientes con EMRR.Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Estudio en fase II de búsqueda de dosis, multicéntrico, aleatorio, de grupos paralelos, parcialmente enmascarado, con placebo y Avonex® como fármacos control, para evaluar la eficacia, determinada por las lesiones cerebrales que aparecen en la RMN y la seguridad de dos pautas terapéuticas de ocrelizumab en pacientes con EMRR.Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Esclerosis Múltiple Recurrente-remitente Relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMab 2H7 Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | France;Czech Republic;Slovakia;Finland;Belgium;Spain;Denmark;Bulgaria;Netherlands;Germany;Italy;United Kingdom | ||
| 182 | EUCTR2007-000381-20-LT (EUCTR) | 15/07/2008 | 06/06/2008 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Germany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon | ||
| 183 | JPRN-UMIN000002725 | 2008/07/01 | 22/11/2009 | Efficacy of ramatroban in multiple sclerosis patients | Efficacy of ramatroban in multiple sclerosis patients - Efficacy of ramatroban | Multiple sclerosis | Addition of ramatroban to conventional MS therapy | Iou hospital | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 5 | Not selected | Japan |
| 184 | EUCTR2007-000381-20-LV (EUCTR) | 29/05/2008 | 12/05/2008 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Portugal;Serbia;Estonia;Saudi Arabia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany | ||
| 185 | EUCTR2007-000381-20-EE (EUCTR) | 19/05/2008 | 28/12/2007 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Germany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon | ||
| 186 | EUCTR2007-005363-10-FR (EUCTR) | 13/05/2008 | 11/12/2007 | Etude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de la RMN multimodale dans l'analyse des lésions de sclérose en plaques : étude longitudinale sur 3 ans d'une cohorte de 50 patients après un premier évènement (CIS patients) à haut risque de développer une sclérose en plaques. - USPIO-CIS | Etude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de la RMN multimodale dans l'analyse des lésions de sclérose en plaques : étude longitudinale sur 3 ans d'une cohorte de 50 patients après un premier évènement (CIS patients) à haut risque de développer une sclérose en plaques. - USPIO-CIS | 1. Multiple Sclerosis2. Clinically isolated syndromes (at high risk to develop Multiple Sclerosis) MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive MedDRA version: 9.1;Classification code 10028246;Term: Multiple sclerosis aggravated MedDRA version: 9.1;Classification code 10028247;Term: Multiple sclerosis like syndrome MedDRA version: 9.1;Classification code 10028248;Term: Multiple sclerosis-like syndrome MedDRA version: 9.1;Classification code 10048393;Term: Multiple sclerosis relapse MedDRA version: 9.1;Classification code 10053395;Term: Progressive multiple sclerosis MedDRA version: 9.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis MedDRA version: 9.1;Classification code 10063401;Term: Primary progressive multiple sclerosis MedDRA version: 9.1;Classification code 10064137;Term: Progression of multiple sclerosis MedDRA version: 9.1;Level: PT;Term: Secondary progressive multiple sclerosis | Product Code: SH U 555 C | C.H.U. de RENNES | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 187 | EUCTR2007-000381-20-PT (EUCTR) | 28/04/2008 | 15/01/2008 | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece | |||
| 188 | NCT00605215 (ClinicalTrials.gov) | April 24, 2008 | 8/1/2008 | BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon ß-1a (Avonex®) | A Multinational, Multicenter, Randomized, Parallel-Group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Laquinimod Over Placebo in a Double-blind Design and of a Reference Arm of Interferon ß-1a (Avonex®) in a Rater-blinded Design | Multiple Sclerosis | Drug: Laquinimod;Drug: Placebo;Drug: Avonex® | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 18 Years | 55 Years | All | 1331 | Phase 3 | United States;Bulgaria;Croatia;Czechia;Estonia;Georgia;Germany;Israel;Italy;Lithuania;North Macedonia;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Czech Republic;Latvia;Macedonia, The Former Yugoslav Republic of;Montenegro;Turkey |
| 189 | EUCTR2007-000381-20-CZ (EUCTR) | 23/04/2008 | 14/12/2007 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Germany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon | ||
| 190 | EUCTR2007-000381-20-DK (EUCTR) | 15/04/2008 | 05/03/2008 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Australia;United States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany | ||
| 191 | NCT01414816 (ClinicalTrials.gov) | April 2008 | 13/7/2011 | Betaferon® Regulatory Post-Marketing Surveillance | Betaferon® Regulatory Post-Marketing Surveillance | Multiple Sclerosis;Clinically Isolated System | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 12 Years | N/A | Both | 355 | N/A | Korea, Republic of |
| 192 | NCT00670449 (ClinicalTrials.gov) | April 2008 | 28/4/2008 | An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis | An Extension of the 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Fingolimod | Novartis | Mitsubishi Tanabe Pharma Corporation | Completed | 18 Years | 60 Years | All | 143 | Phase 2 | Japan |
| 193 | NCT00642902 (ClinicalTrials.gov) | April 2008 | 21/3/2008 | A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS) | A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment Course | Relapsing Multiple Sclerosis | Drug: Atacicept;Drug: Placebo matched to atacicept | EMD Serono | NULL | Terminated | 18 Years | 60 Years | All | 255 | Phase 2 | United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Lebanon;Lithuania;Netherlands;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom |
| 194 | EUCTR2007-000381-20-DE (EUCTR) | 17/03/2008 | 28/02/2008 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Portugal;Serbia;Estonia;Saudi Arabia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany | ||
| 195 | EUCTR2007-002179-15-FR (EUCTR) | 04/03/2008 | 22/11/2007 | Etude des effets de la méthylprednisolone à fortes doses sur les caractéritiques électrophysiologiques de la fatigabilité à l'effort au cours des poussées de sclérose en plaques - CORTICOFLASH | Etude des effets de la méthylprednisolone à fortes doses sur les caractéritiques électrophysiologiques de la fatigabilité à l'effort au cours des poussées de sclérose en plaques - CORTICOFLASH | Méthylprednisolone administrée aux patients et contrôles à la dose de 1g/j pendant 3 jours, comme prescrit habituellement dans le cadre de leur pathologie. MedDRA version: 8.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Methylprednisolone Product Name: Methylprednisolone INN or Proposed INN: Methylprednisolone | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 196 | EUCTR2007-000381-20-GB (EUCTR) | 04/03/2008 | 26/11/2007 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Latvia;Netherlands;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany | ||
| 197 | EUCTR2007-000381-20-BE (EUCTR) | 21/01/2008 | 20/12/2007 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Denmark;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany | ||
| 198 | EUCTR2006-001152-12-HU (EUCTR) | 09/01/2008 | 09/10/2007 | Not applicable | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. - TOPIC | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | |||
| 199 | EUCTR2007-000381-20-AT (EUCTR) | 30/12/2007 | 03/01/2008 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Germany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon | ||
| 200 | EUCTR2007-000381-20-FR (EUCTR) | 14/12/2007 | 17/10/2007 | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Extension trial to Trial 25643: Oral Cladribine in MS | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Extension trial to Trial 25643: Oral Cladribine in MS | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Portugal;Estonia;Greece;Finland;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Bulgaria;Latvia;Netherlands;Germany | ||
| 201 | EUCTR2006-002982-38-LT (EUCTR) | 30/11/2007 | 01/10/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 202 | EUCTR2007-000381-20-FI (EUCTR) | 16/11/2007 | 15/10/2007 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Germany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon | ||
| 203 | EUCTR2006-003037-32-LT (EUCTR) | 11/09/2007 | 27/11/2006 | A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | Relapsing remitting Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10063399 | Trade Name: Rebif Product Name: Interferon beta-1a FBS-free/HSA-free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta 1a Other descriptive name: Not applicable | Merck Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Germany;Estonia;Spain;Italy;Lithuania | ||
| 204 | EUCTR2006-002633-20-LT (EUCTR) | 07/09/2007 | 05/07/2007 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania | |||
| 205 | EUCTR2006-002633-20-FR (EUCTR) | 04/07/2007 | 11/09/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Finland;Spain;Lithuania;Austria;Germany;Netherlands;United Kingdom;Italy | ||
| 206 | EUCTR2006-005270-47-GR (EUCTR) | 03/07/2007 | 18/06/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 207 | EUCTR2006-007057-42-DK (EUCTR) | 25/06/2007 | 14/05/2007 | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | relapsing forms of multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: firategrast (USAN approved name) Product Code: SB-683699 Other descriptive name: firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 45 | Czech Republic;Denmark;Sweden | |||
| 208 | EUCTR2006-007057-42-BE (EUCTR) | 29/05/2007 | 14/02/2007 | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | relapsing forms of multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: firategrast (USAN approved name) Product Code: SB-683699 Other descriptive name: firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 45 | Czech Republic;Belgium;Denmark;Sweden | |||
| 209 | EUCTR2006-002982-38-PT (EUCTR) | 29/05/2007 | 22/02/2007 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 210 | EUCTR2006-005270-47-FR (EUCTR) | 22/05/2007 | 23/01/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden | ||
| 211 | EUCTR2006-005270-47-SI (EUCTR) | 16/05/2007 | 04/04/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 212 | EUCTR2006-002982-38-GR (EUCTR) | 08/05/2007 | 29/12/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Not Applicable Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 213 | EUCTR2006-007057-42-CZ (EUCTR) | 03/05/2007 | 16/03/2007 | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | relapsing forms of multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: firategrast (USAN approved name) Product Code: SB-683699 Other descriptive name: firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Czech Republic;Belgium;Denmark;Sweden | ||
| 214 | EUCTR2006-005270-47-LV (EUCTR) | 02/05/2007 | 03/04/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 215 | EUCTR2006-007057-42-SE (EUCTR) | 02/05/2007 | 15/02/2007 | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | An open-label study of leukocyte counts in the cerebrospinal fluid and blood of subjects with relapsing forms of multiple sclerosis following treatment with firategrast | relapsing forms of multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis | Product Name: firategrast (USAN approved name) Product Code: SB-683699 Other descriptive name: firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 45 | Czech Republic;Denmark;Sweden | |||
| 216 | EUCTR2006-005270-47-FI (EUCTR) | 23/04/2007 | 19/12/2006 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden | ||
| 217 | NCT00548769 (ClinicalTrials.gov) | April 21, 2007 | 23/10/2007 | Firategrast (SB683699) Surface Area Study in Multiple Sclerosis Patients | An Open-label, Randomised, Four Period Crossover Study to Investigate the Relative Pharmacokinetic Profiles of Tablets From Three Batches of Firategrast With Different Surface Areas and Two Different Tablet Formulations Containing the Same Batch of Firategrast, Given as Single 900mg Doses to Male and Female Subjects With a Diagnosis of Multiple Sclerosis | Multiple Sclerosis | Drug: Formulation A;Drug: Formulation B;Drug: Formulation C;Drug: Formulation D | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | All | 37 | Phase 1 | Czechia;Germany;Poland;Czech Republic |
| 218 | EUCTR2006-005270-47-HU (EUCTR) | 16/04/2007 | 09/03/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 219 | EUCTR2006-003037-32-DE (EUCTR) | 13/04/2007 | 01/12/2006 | A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | Relapsing remitting Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10063399 | Trade Name: Rebif Product Name: Interferon beta-1a FBS-free/HSA-free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta 1a Other descriptive name: Not applicable | Merck Serono SA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Germany;Estonia;Spain;Italy;Lithuania | ||
| 220 | EUCTR2006-005270-47-BE (EUCTR) | 12/04/2007 | 22/12/2006 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden | ||
| 221 | EUCTR2006-005270-47-NL (EUCTR) | 02/04/2007 | 18/04/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 222 | NCT00468182 (ClinicalTrials.gov) | April 2007 | 30/4/2007 | Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis | Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon-beta 1b (Betaseron) | Rutgers, The State University of New Jersey | Bayer | Completed | 18 Years | 60 Years | Both | 24 | United States | |
| 223 | NCT00475865 (ClinicalTrials.gov) | April 2007 | 18/5/2007 | Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis | A Randomized, Multinational, Double-blind, Placebo-controlled, Parallel-group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Glatiramer Acetate in Subjects With Multiple Sclerosis | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Glatiramer Acetate (GA) | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 123 | Phase 2 | United States;Austria;Canada;Germany;Italy;United Kingdom |
| 224 | NCT00472797 (ClinicalTrials.gov) | April 2007 | 10/5/2007 | Rebif New Formulation (RNF) Quality of Life (QOL) Study | A Randomized, Multicenter, Two-arm, 12 Week Phase IIIb Study to Evaluate Quality of Life (QOL) Measures in Subjects With Relapsing Forms of Multiple Sclerosis (MS) Who Are Transitioning From Rebif® (Interferon Beta-1a) to Rebif New Formulation (RNF) | Relapsing Multiple Sclerosis | Drug: Rebif New Formulation Non Titrated;Drug: Rebif New Formulation Titrated | EMD Serono | NULL | Completed | 18 Years | 60 Years | All | 232 | Phase 3 | United States |
| 225 | EUCTR2006-002633-20-IT (EUCTR) | 26/03/2007 | 05/02/2007 | Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 - 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 - 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Firategrast Product Code: SB683699 INN or Proposed INN: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 INN or Proposed INN: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | France;Finland;Spain;Lithuania;Austria;Germany;Netherlands;United Kingdom;Italy | |||
| 226 | EUCTR2006-002982-38-DE (EUCTR) | 16/03/2007 | 10/10/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany | ||
| 227 | EUCTR2006-002982-38-EE (EUCTR) | 15/03/2007 | 31/10/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono International, a branch of Laboratoires Serono SA An affiliate of Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 228 | EUCTR2006-003037-32-EE (EUCTR) | 06/03/2007 | 26/01/2007 | A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | Relapsing remitting Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10063399 | Trade Name: Rebif Product Name: Interferon beta-1a FBS-free/HSA-free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta 1a Other descriptive name: Not applicable | Merck Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Germany;Estonia;Spain;Italy;Lithuania | ||
| 229 | EUCTR2006-005270-47-SE (EUCTR) | 28/02/2007 | 02/02/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer AB, Bayer Health Care, Bayer Schering Pharma | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 230 | EUCTR2006-005270-47-AT (EUCTR) | 22/02/2007 | 31/01/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Germany;Latvia;Netherlands;Sweden | ||
| 231 | EUCTR2006-003366-33-ES (EUCTR) | 13/02/2007 | 03/03/2010 | Estudio multicéntrico en fase II, aleatorizado, doble ciego y controlado frente a placebo, de seguridad, tolerabilidad y eficacia del tratamiento con Cladribina en comprimidos añadido a Rebif New Formulation, en pacientes con Esclerosis Múltiple Activa.A phase II, multi-center, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif new formulation in multiple sclerosis subjects with active disease. - Estudio en fase II de Rebif NF más Cladribina en pacientes con Esclerosis Múltiple Activa | Estudio multicéntrico en fase II, aleatorizado, doble ciego y controlado frente a placebo, de seguridad, tolerabilidad y eficacia del tratamiento con Cladribina en comprimidos añadido a Rebif New Formulation, en pacientes con Esclerosis Múltiple Activa.A phase II, multi-center, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif new formulation in multiple sclerosis subjects with active disease. - Estudio en fase II de Rebif NF más Cladribina en pacientes con Esclerosis Múltiple Activa | Pacientes con esclerosis múltiple activa MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: not applicable Product Name: Interferon beta-1a FBS-free/HSA free, RNF Product Code: Not applicable Trade Name: not applicable Product Name: cladribina oral Product Code: not applicable INN or Proposed INN: cladribine | Serono International, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 2 | Spain;Italy | ||
| 232 | EUCTR2006-003037-32-ES (EUCTR) | 09/02/2007 | 10/03/2010 | Estudio en fase IIIb, multicéntrico, comparado con grupo de control, doble ciego, aleatorizado y de dos brazos, con evaluaciones mensuales por resonancia magnética y biomarcadores para evaluar la eficacia, la seguridad y la tolerabilidad de Rebif New Formulation (IFN beta-1a) en pacientes con esclerosis múltiple remitente-recurrente.A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | Estudio en fase IIIb, multicéntrico, comparado con grupo de control, doble ciego, aleatorizado y de dos brazos, con evaluaciones mensuales por resonancia magnética y biomarcadores para evaluar la eficacia, la seguridad y la tolerabilidad de Rebif New Formulation (IFN beta-1a) en pacientes con esclerosis múltiple remitente-recurrente.A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | Relapsing remitting Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10063399 | Trade Name: Rebif Product Name: Interferon beta-1a FBS-free/HSA-free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta 1a Other descriptive name: Not applicable | Merck Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Estonia;Spain;Lithuania;Germany;Italy | ||
| 233 | EUCTR2006-002633-20-GB (EUCTR) | 25/01/2007 | 10/02/2012 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Finland;Spain;Lithuania;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 234 | EUCTR2006-002982-38-SK (EUCTR) | 12/01/2007 | 06/10/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono International, a branch of Laboratoires Serono SA An affiliate of Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany | ||
| 235 | EUCTR2006-002982-38-FR (EUCTR) | 05/01/2007 | 24/10/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Not Applicable Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany | ||
| 236 | NCT03135327 (ClinicalTrials.gov) | January 1, 2007 | 24/4/2017 | Clinical Applications of Advanced Ophthalmic Imaging | Clinical Applications of Advanced Ophthalmic Imaging | Multiple Sclerosis;Dry Eye Syndromes;Diabetic Retinopathy;Presbyopia;Myopia;Dementia | Dietary Supplement: Ocufolin | University of Miami | NULL | Recruiting | 18 Years | 99 Years | All | 5000 | N/A | United States |
| 237 | EUCTR2006-002982-38-DK (EUCTR) | 20/12/2006 | 30/11/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Not Applicable Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Denmark;Belgium;Estonia;Spain;Greece | ||
| 238 | EUCTR2006-002982-38-FI (EUCTR) | 19/12/2006 | 19/10/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 239 | EUCTR2006-002633-20-FI (EUCTR) | 05/12/2006 | 04/09/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania | |||
| 240 | EUCTR2006-002982-38-AT (EUCTR) | 04/12/2006 | 29/09/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Not Applicable Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 241 | EUCTR2006-002633-20-ES (EUCTR) | 01/12/2006 | 13/04/2012 | Estudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrente | Estudio aleatorizado, doble-ciego, controlado con placebo, de grupos paralelos, de definición de dosis, para investigar la eficacia mediante RM y la seguridad de la administración de firategrast (150 - 1.200 mg, dos veces al día), durante seis meses, en sujetos con esclerosis múltiple remitente-recurrente | Esclerosis múltiple remitente-recurrente MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline S.A | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Finland;Spain;Lithuania;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Germany;Netherlands;Norway;New Zealand | ||
| 242 | EUCTR2006-002982-38-BE (EUCTR) | 29/11/2006 | 14/09/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A.-Geneva, an affiliate of Merck KGaA Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany | ||
| 243 | EUCTR2006-000606-23-ES (EUCTR) | 23/11/2006 | 15/03/2012 | ?Post-authorization safety study to check the potential association between the safetyprofile of beta interferon 1a and the body mass index or pharmacodynamics during thetitration phase | Post-authorization safety study to check the potential association between the safetyprofile of beta interferon 1a and the body mass index or pharmacodynamics during thetitration phase - PASS-PD del escalado de dosis de Rebif | Not applicalbe MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif 22 y 44 mcg Product Name: Interferon-beta-1a Other descriptive name: INTERFERON BETA-1A | Merck, S.L. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Spain | ||
| 244 | EUCTR2006-002633-20-NL (EUCTR) | 17/11/2006 | 10/08/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania | |||
| 245 | EUCTR2006-002982-38-CZ (EUCTR) | 03/11/2006 | 15/09/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 246 | EUCTR2006-002633-20-DE (EUCTR) | 25/10/2006 | 23/08/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | France;Finland;Spain;Lithuania;Austria;Netherlands;Germany;United Kingdom;Italy | |||
| 247 | EUCTR2006-001161-42-SE (EUCTR) | 17/10/2006 | 29/05/2006 | Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - Not applicable | Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - Not applicable | Multiple sclerosis (MS) | Product Name: DACLIZUMAB HYP Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 232 | Hungary;Germany;United Kingdom;Sweden | |||
| 248 | EUCTR2004-002567-24-GB (EUCTR) | 09/10/2006 | 22/02/2005 | A Phase 2a Magnetic Resonance Study of the Safety and Efficacy of MLN1202 in Patients with Multiple Sclerosis - Not applicable | A Phase 2a Magnetic Resonance Study of the Safety and Efficacy of MLN1202 in Patients with Multiple Sclerosis - Not applicable | The purpose of this study is to investigate the safety, PK parameters, PD responses, and clinical responses of multiple dose administration of MLN1202 in patients with relapsing remitting multiple sclerosis (RRMS). MedDRA version: 8.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: MLN1202 Product Code: MLN1202 | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Czech Republic;United Kingdom | ||
| 249 | EUCTR2006-002633-20-AT (EUCTR) | 05/10/2006 | 14/09/2006 | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) Product Name: Firategrast Product Code: SB683699 Other descriptive name: Firategrast (USAN approved name) | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Finland;United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Lithuania | |||
| 250 | EUCTR2005-005751-18-GB (EUCTR) | 07/09/2006 | 17/02/2006 | A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy Study | A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy Study | Multiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system of unknown aetiology. It is the commonest cause of disability in young adults. The prevalence in the UK is approximately 125/100,000 of the population with an annual incidence of 6/100,000. Approximately 80,000 individuals are affected with MS in the UK. | Trade Name: Rebif 44 Product Name: Rebif 44 Product Code: Interferon beta 1a INN or Proposed INN: Interferon beta 1a Trade Name: Rebif 22 Product Name: Rebif 22 Product Code: Interferon beta 1a INN or Proposed INN: Interferon beta 1a Product Name: Betaferon 500mcg Product Code: Betaferon 500mcg INN or Proposed INN: Interferon beta 1b | UCL Biomedicine R&D Unit | NULL | Not Recruiting | Female: yes Male: yes | 100 | United Kingdom | |||
| 251 | NCT00261326 (ClinicalTrials.gov) | September 2006 | 2/12/2005 | Simvastatin Treatment of Patients With Acute Optic Neuritis | Simvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III Trial | Optic Neuritis;Multiple Sclerosis | Drug: simvastatin;Drug: placebo | Glostrup University Hospital, Copenhagen | Alpharma ApS | Active, not recruiting | 18 Years | 59 Years | Both | 64 | Phase 3 | Denmark |
| 252 | EUCTR2004-005148-28-LT (EUCTR) | 18/07/2006 | 02/05/2006 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania | ||
| 253 | EUCTR2004-005148-28-LV (EUCTR) | 05/06/2006 | 11/01/2007 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania | ||
| 254 | EUCTR2004-005148-28-SK (EUCTR) | 01/06/2006 | 25/04/2006 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Czech Republic;Estonia;Slovakia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Italy;United Kingdom | ||
| 255 | EUCTR2004-005148-28-AT (EUCTR) | 22/11/2005 | 18/10/2005 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Czech Republic;Estonia;Finland;Lithuania;Denmark;Austria;Latvia;Germany;Italy;United Kingdom | ||
| 256 | EUCTR2004-005148-28-DE (EUCTR) | 17/11/2005 | 16/05/2006 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Merck Serono International, a branch of Laboratories Serono S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Finland;Czech Republic;United Kingdom;Germany;Denmark;Estonia;Italy;Latvia;Lithuania | ||
| 257 | NCT00273364 (ClinicalTrials.gov) | November 16, 2005 | 5/1/2006 | Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized Study | Hematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study | Multiple Sclerosis | Procedure: Hematopoietic Stem Cell Therapy;Drug: Standard treatment with a conventional drug | Northwestern University | Uppsala University;Sheffield Teaching Hospitals NHS Foundation Trust;University of Sao Paulo | Completed | 18 Years | 55 Years | All | 110 | Phase 2 | United States |
| 258 | EUCTR2005-001008-37-SE (EUCTR) | 01/11/2005 | 21/03/2005 | Analysis of the antibody level against interferon beta before and after increase of dose in MS therapy - Interferon beta dose and antibody | Analysis of the antibody level against interferon beta before and after increase of dose in MS therapy - Interferon beta dose and antibody | Multiple sclerosis | Trade Name: Rebif® Product Name: Rebif® Product Code: Not applicable INN or Proposed INN: Interferon beta-1a | Sahlgrenska University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Sweden | |||
| 259 | NCT00313976 (ClinicalTrials.gov) | November 2005 | 11/4/2006 | Study to Compare Double-dose Betaferon to the Approved Dose, for Patients With Early Secondary Progressive Multiple Sclerosis (SPMS) | A Scandinavian, Randomized, Rater-blinded Study of Single and Double-dose Betaferon in Patients With Early Secondary Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) | Bayer | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 3 | Denmark;Sweden |
| 260 | EUCTR2004-005148-28-GB (EUCTR) | 28/10/2005 | 20/04/2005 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Merck Serono International, a branch of Laboratoires Serono S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Estonia;Slovakia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Italy;United Kingdom | ||
| 261 | EUCTR2004-005148-28-EE (EUCTR) | 09/09/2005 | 31/05/2005 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania | ||
| 262 | EUCTR2004-002567-24-HU (EUCTR) | 19/07/2005 | 06/04/2005 | A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not applicable | A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not applicable | The purpose of this study is to investigate the safety, PK parameters, PD responses, and clinical responses of multiple dose administration of MLN1202 in patients with relapsing remitting multiple sclerosis (RRMS). | Product Name: MLN1202 Product Code: MLN1202 INN or Proposed INN: Not yet available Other descriptive name: Not yet available | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;United Kingdom;Czech Republic | ||
| 263 | EUCTR2004-005148-28-CZ (EUCTR) | 14/07/2005 | 15/06/2005 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Finland;Germany;United Kingdom;Czech Republic;Denmark;Estonia;Italy;Latvia;Lithuania | ||
| 264 | EUCTR2004-005148-28-BE (EUCTR) | 14/06/2005 | 05/07/2005 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Czech Republic;Estonia;Finland;Belgium;Lithuania;Austria;Denmark;Latvia;Germany;Italy;United Kingdom | ||
| 265 | EUCTR2004-005148-28-DK (EUCTR) | 02/06/2005 | 09/05/2005 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania | ||
| 266 | NCT00202397 (ClinicalTrials.gov) | June 2005 | 12/9/2005 | Effect of Riluzole as a Symptomatic Approach in Patients With Chronic Cerebellar Ataxia | Phase 2 Study of Riluzole Effects on Patients With Chronic Cerebellar Ataxia | Hereditary Ataxia;Multiple Sclerosis;Cerebellar Ataxia | Drug: Riluzole;Other: placebo | S. Andrea Hospital | NULL | Completed | 18 Years | 80 Years | Both | 40 | Phase 2 | Italy |
| 267 | EUCTR2004-005148-28-FI (EUCTR) | 26/05/2005 | 18/04/2005 | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS | Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Cladribine Product Code: Not Applicable INN or Proposed INN: Cladribine Other descriptive name: 2-chloro-2'-deoxyadenosine, 2CdA | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1290 | Phase 3 | Finland;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Italy;Latvia;Lithuania | ||
| 268 | EUCTR2004-002567-24-CZ (EUCTR) | 04/04/2005 | 04/02/2005 | A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not appilcable | A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not appilcable | The purpose of this study is to investigate the safety, PK parameters, PD responses, and clinical responses of multiple dose administration of MLN1202 in patients with relapsing remitting multiple sclerosis (RRMS). | Product Name: MLN1202 Product Code: MLN1202 INN or Proposed INN: Not yet available Other descriptive name: Not yet available | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;United Kingdom;Czech Republic | ||
| 269 | NCT00109161 (ClinicalTrials.gov) | April 2005 | 22/4/2005 | Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis | A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: Daclizumab (Anti-CD25 Humanized Monoclonal Antibody) | PDL BioPharma, Inc. | NULL | Completed | 18 Years | 55 Years | Both | 270 | Phase 2 | United States;Canada |
| 270 | NCT00668343 (ClinicalTrials.gov) | April 2005 | 27/4/2008 | Simvastatin in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Using Avonex Compared to Placebo | Relapsing Remitting Multiple Sclerosis | Drug: simvastatin;Drug: placebo | Tehran University of Medical Sciences | NULL | Completed | 15 Years | 60 Years | Both | 80 | Phase 3 | Iran, Islamic Republic of | |
| 271 | NCT00213135 (ClinicalTrials.gov) | April 2005 | 13/9/2005 | A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) | A Phase III, Randomized, Double-blind, Three-arm, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis, Relapsing-Remitting | Drug: Cladribine 5.25 mg/kg;Drug: Cladribine 3.5 mg/kg;Other: Placebo | EMD Serono | NULL | Completed | 18 Years | 65 Years | All | 1326 | Phase 3 | Canada;Switzerland |
| 272 | EUCTR2004-003799-13-GB (EUCTR) | 16/03/2005 | 18/07/2005 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden | ||
| 273 | EUCTR2004-003799-13-LT (EUCTR) | 08/03/2005 | 27/12/2004 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | United Kingdom;Spain;Ireland;Sweden;Lithuania | ||
| 274 | EUCTR2004-003799-13-DK (EUCTR) | 24/02/2005 | 18/01/2005 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden | ||
| 275 | EUCTR2004-004130-14-AT (EUCTR) | 17/02/2005 | 13/01/2005 | A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week). | A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week). | Male and female subjects with relapsing multiple sclerosis previously treated with interferon beta-1a (22 mcg or 44 mcg, SC three times a week). | Product Name: Natalizumab Product Code: Not Applicable INN or Proposed INN: natalizumab Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: Interferon beta-1a | Biogen Idec GmbH | NULL | Not Recruiting | Female: yes Male: yes | 1050 | Austria | |||
| 276 | EUCTR2004-003799-13-ES (EUCTR) | 17/02/2005 | 04/11/2005 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden | ||
| 277 | EUCTR2004-003799-13-SE (EUCTR) | 03/02/2005 | 23/12/2004 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | United Kingdom;Spain;Ireland;Lithuania;Sweden | ||
| 278 | EUCTR2004-000337-12-HU (EUCTR) | 23/07/2004 | 29/09/2004 | A multicentre, single arm, open-label, phase IV study to evaluate the immunogenicity and safety of subcutaneously administered r-hIFN beta-1a (Rebif) using clone 484-39 in the treatment of subjects with Relapsing Remitting Multiple Sclerosis - EMEA Post Approval Commitment New Clone Study | A multicentre, single arm, open-label, phase IV study to evaluate the immunogenicity and safety of subcutaneously administered r-hIFN beta-1a (Rebif) using clone 484-39 in the treatment of subjects with Relapsing Remitting Multiple Sclerosis - EMEA Post Approval Commitment New Clone Study | MS with 2 or more relapses within the last 2 years MedDRA version: 7.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Rebif Product Code: Not applicable INN or Proposed INN: Interferon beta-1a Other descriptive name: Recombinant human interferon beta Trade Name: Rebif Product Name: Rebif Product Code: Not applicable INN or Proposed INN: Interferon beta-1a Other descriptive name: Recombinant human interferon beta | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 4 | Hungary | ||
| 279 | NCT00202995 (ClinicalTrials.gov) | July 2004 | 13/9/2005 | Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMS | A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to That of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients | Relapsing Remitting Multiple Sclerosis | Drug: Glatiramer Acetate;Drug: Betaseron;Drug: Rebif | Teva Pharmaceutical Industries | NULL | Terminated | 18 Years | 50 Years | Both | 91 | Phase 4 | United States;Canada |
| 280 | NCT00682929 (ClinicalTrials.gov) | April 14, 2004 | 19/5/2008 | Cannabis for Spasticity in Multiple Sclerosis | Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study | Multiple Sclerosis | Drug: Inhaled Cannabis;Drug: Oral THC;Drug: Oral Placebo;Drug: Inhaled placebo | University of California, Davis | National Multiple Sclerosis Society | Terminated | 21 Years | N/A | All | 41 | Phase 1/Phase 2 | United States |
| 281 | NCT01233245 (ClinicalTrials.gov) | April 2004 | 14/10/2010 | BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus Program | BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus Program | Relapsing Remitting MS (RRMS);Secondary Progressive MS (SPMS) | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | Both | 1077 | N/A | Czech Republic;France;Germany;Iran, Islamic Republic of;Israel;Italy;Jordan;Korea, Republic of;Lebanon;Netherlands;Portugal;Saudi Arabia;Spain;Taiwan;Turkey |
| 282 | NCT00300716 (ClinicalTrials.gov) | April 2004 | 8/3/2006 | Trial of Memantine for Cognitive Impairment in Multiple Sclerosis | Double Blind Placebo Controlled Pilot Trial of Memantine for Cognitive Impairment in Multiple Sclerosis | Multiple Sclerosis;Cognition Disorders | Drug: Memantine | Oregon Health and Science University | Forest Laboratories;University of Southern California;University of Texas Southwestern Medical Center;MS-Hub Seattle | Completed | 18 Years | 65 Years | All | 82 | Phase 2/Phase 3 | United States |
| 283 | NCT00086671 (ClinicalTrials.gov) | April 2004 | 7/7/2004 | Safety and Effectiveness of Two Doses of ABT-874 as Compared to Placebo in Subjects With Multiple Sclerosis (MS) | A 24-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose Finding, Safety, Tolerability, and Efficacy Study of the Human Anti-IL-12 Antibody ABT-874 in Subjects With Multiple Sclerosis With a 24-Week Double-Blind, Active Extension Phase | Multiple Sclerosis | Drug: ABT-874/Human monoclonal antibody against IL-12;Drug: Placebo | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | 60 Years | Both | 215 | Phase 2 | United States;Canada;Germany;Netherlands;United Kingdom |
| 284 | NCT00217295 (ClinicalTrials.gov) | April 2004 | 14/9/2005 | A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis | A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis. | Multiple Sclerosis | Drug: Avonex and Topamax | Multiple Sclerosis Institute | NULL | Recruiting | 18 Years | 55 Years | Both | 30 | Phase 2 | United States |
| 285 | NCT00202982 (ClinicalTrials.gov) | August 2003 | 12/9/2005 | A Study to Test the Effectiveness and Safety of a New Higher 40mg Dose of Copaxone® Compared to Copaxone® 20mg, the Currently Approved Dose | A Multi-Center, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy, Tolerability and Safety of 40 mg of Copaxone in the Treatment of Relapsing-Remitting Multiple Sclerosis Patients | Relapse-Remitting Multiple Sclerosis | Drug: glatiramer acetate 20 mg;Drug: glatiramer acetate 40 mg | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 50 Years | Both | 90 | Phase 2 | United States |
| 286 | NCT00298662 (ClinicalTrials.gov) | February 2003 | 2/3/2006 | Combination Therapy of Betaseron-Prograf in Multiple Sclerosis | A Pilot Safety and Tolerability Open-Label Study of Interferon Beta-1b in Combination With Tacrolimus in Patients Suffering From Multiple Sclerosis Who Have Failed Treatment With Approved Disease Modifying Agents | Multiple Sclerosis | Drug: Interferon beta-1b and Tacrolimus | Clinique de sclérose en plaques et neuromusculaire de l'Outaouais | NULL | Active, not recruiting | 18 Years | 55 Years | Both | 30 | Phase 2 | Canada |
| 287 | NCT00053417 (ClinicalTrials.gov) | February 2003 | 29/1/2003 | Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis | Double-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis | Multiple Sclerosis | Drug: Placebo;Drug: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP);Drug: 15 mg fampridine-SR (4-aminopyridine, 4-AP);Drug: 20 mg fampridine-SR (4-aminopyridine, 4-AP) | Acorda Therapeutics | NULL | Completed | 18 Years | 70 Years | All | 206 | Phase 2 | United States;Canada |
| 288 | NCT00405353 (ClinicalTrials.gov) | April 2002 | 28/11/2006 | Testosterone Treatment for Multiple Sclerosis | Testosterone Treatment for Multiple Sclerosis: A Preliminary Trial | Multiple Sclerosis | Drug: Androgel 10 grams of gel containing 100 mg of testosterone | University of California, Los Angeles | National Multiple Sclerosis Society | Completed | 18 Years | 65 Years | Male | 10 | Phase 1/Phase 2 | United States |
| 289 | NCT01487096 (ClinicalTrials.gov) | April 2001 | 5/12/2011 | Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses | A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (placebo for teriflunomide) | Sanofi | NULL | Completed | 18 Years | 65 Years | Both | 179 | Phase 2 | Canada;France |
| 290 | NCT00017628 (ClinicalTrials.gov) | April 2001 | 6/6/2001 | Phase I Study of High-Dose Cyclophosphamide and Total Body Irradiation With T Lymphocyte-Depleted Autologous Peripheral Blood Stem Cell or Bone Marrow Rescue in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: cyclophosphamide;Drug: filgrastim;Drug: methylprednisolone;Procedure: Autologous Stem Cell Transplantation | Northwestern Memorial Hospital | NULL | Completed | N/A | 59 Years | Both | 20 | Phase 1 | United States | |
| 291 | NCT00040482 (ClinicalTrials.gov) | April 1999 | 26/6/2002 | High Dose Chemo/Radiotherapy and Hematopoietic Stem Cell Transplant for Patients With Multiple Sclerosis | Intensive Immunosuppression Followed by Rescue With CD34 Selected, T Cell Depleted, Leukopheresis Products in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Cyclophosphamide;Drug: ATG;Drug: MESNA;Procedure: Radiation therapy | Baylor College of Medicine | The Methodist Hospital System;Center for Cell and Gene Therapy, Baylor College of Medicine | Completed | 18 Years | 60 Years | All | 10 | Phase 2 | United States |
| 292 | NCT00006060 (ClinicalTrials.gov) | April 1999 | 5/7/2000 | Diagnostic Study of Quantitative Imaging and Spectroscopy in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: standard gadolinium contrast | National Center for Research Resources (NCRR) | University of Pennsylvania | Recruiting | 20 Years | 70 Years | Both | 100 | N/A | United States | |
| 293 | EUCTR2006-005270-47-DE (EUCTR) | 09/02/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | |||
| 294 | EUCTR2004-003799-13-IE (EUCTR) | 13/01/2005 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden | |||
| 295 | JPRN-JapicCTI-050031 | 06/09/2005 | Intrathecal Baclofen therapy with the implanted pump system for Spastic Palsy (Post-marketing clinical trial extended phase 3 after NDA approval) | Intrathecal Baclofen therapy with the implanted pump system for Spastic Palsy (Post-marketing clinical trial extended phase 3 after NDA approval) | [Spinal cord Origin] Spinal cord Injury, Multiple sclerosis, Spinocerebellar degeneration, Circulatory disorder of the spinal, Ossification of the posterior longitudinal ligament [Cerebral Origin] Cerebral palsy, Traumatic head injury | Intervention name : Baclofen Dosage And administration of the intervention : Intertheacal injection | DAIICHI SANKYO COMPANY, LIMITED | NULL | BOTH | Phase 4 | NULL |
299. 嚢胞性線維症
臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05696912 (ClinicalTrials.gov) | January 30, 2023 | 7/12/2022 | Functional Tests to Resolve Unsolved Rare Diseases. Rares. | Resolving Unsolved Rare Diseases : Functional Tests and New Diagnosis Strategy to Study Genetic Variants From High-throughput Sequencing (RID) | Intellectual Disability;Rubinstein-Taybi Syndrome;Cystic Fibrosis;Congenital Heart Defect;Periventricular Nodular Heterotopia;Neurodegeneration With Brain Iron Accumulation (NBIA);Albinism | Genetic: Ex-vivo approach concerning 25 patients;Genetic: In-vitro approach concerning 25 patients | University Hospital, Bordeaux | NULL | Recruiting | N/A | N/A | All | 50 | N/A | France |
| 2 | NCT05616221 (ClinicalTrials.gov) | January 10, 2023 | 7/11/2022 | Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection | A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 Multi-Phage Therapeutic in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection | Non-cystic Fibrosis Bronchiectasis;Pseudomonas Aeruginosa;Lung Infection | Biological: AP-PA02;Other: Placebo | Armata Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | N/A | All | 60 | Phase 2 | United States |
| 3 | NCT05699148 (ClinicalTrials.gov) | April 1, 2022 | 10/1/2023 | Gut Imaging for Function and Transit in Cystic Fibrosis 3 Junior | Gut Imaging for Function and Transit in Cystic Fibrosis 3 Junior: an Evaluation of Triple Combination Therapy in Children Aged 6 to 11 Years | Cystic Fibrosis | Drug: Elexacaftor / Ivacaftor / Tezacaftor | Nottingham University Hospitals NHS Trust | NULL | Active, not recruiting | 6 Years | 11 Years | All | 17 | United Kingdom | |
| 4 | NCT04702360 (ClinicalTrials.gov) | June 23, 2021 | 6/1/2021 | ELX/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients With at Least One F508del Mutation | ELX/TEZ/IVA Expanded Access Program for Patients 6 Through 11 Years of Age With Cystic Fibrosis Who Have At Least One F508del Mutation | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Approved for marketing | 6 Years | 11 Years | All | NULL | ||
| 5 | NCT04884308 (ClinicalTrials.gov) | April 28, 2021 | 7/5/2021 | Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections | Effects of BCG Vaccine on the Immune System of Individuals With Cystic Fibrosis, Non-Cystic Fibrosis Bronchiectasis, and Healthy Volunteers | Cystic Fibrosis;Bronchiectasis Adult;Non-Tuberculous Mycobacteria | Biological: BCG TICE Vaccine | Johns Hopkins University | Cystic Fibrosis Foundation | Recruiting | 18 Years | 65 Years | All | 180 | Phase 2 | United States |
| 6 | NCT04966234 (ClinicalTrials.gov) | April 22, 2021 | 19/3/2021 | A New Posaconazole Dosing Regimen for Paediatric Patients With Cystic Fibrosis and Aspergillus Infection | Prospective Validation and Clinical Evaluation of a New Posaconazole Dosing Regimen for Children and Adolescents With Cystic Fibrosis and Aspergillus Infection | Cystic Fibrosis;Aspergillosis | Drug: Posaconazole 100 MG [Noxafil];Drug: Posaconazole 40 MG/ML | Bambino Gesù Hospital and Research Institute | University of Exeter;Radboud University;Consorzio per Valutazioni Biologiche e Farmacologiche | Recruiting | 8 Years | 17 Years | All | 135 | Phase 2/Phase 3 | Czechia;France;Germany;Greece;Ireland;Italy;Netherlands;Portugal;Spain;Switzerland;United Kingdom |
| 7 | NCT04731272 (ClinicalTrials.gov) | April 20, 2021 | 26/1/2021 | GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance | Effect of GLP-1 Agonist Therapy on Insulin Secretion in Adults With Pancreatic Insufficient Cystic Fibrosis and Abnormal Glucose Tolerance: a Randomized, Open-label, Cross-over Trial | Cystic Fibrosis;Pancreatic Insufficiency;Abnormal Glucose Tolerance;Diabetes | Drug: Dulaglutide 0.75Mg/0.5Ml Inj Pen | University of Pennsylvania | Children's Hospital of Philadelphia | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 8 | EUCTR2020-005931-58-FR (EUCTR) | 02/04/2021 | 04/02/2021 | ACTIVE : ACid tranexamic or Terlipressin for Initial emergency treatment of mild to seVere hEmoptysis | ACTIVE : ACid tranexamic or Terlipressin for Initial emergency treatment of mild to seVere hEmoptysis - ACTIVE | Hemoptysis, whatever the cause, with the exception of cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: GLYPRESSINE 1 mg/5 mL, poudre et solvant pour solution injectable (I.V.) INN or Proposed INN: TERLIPRESSIN Other descriptive name: Terlipressin acetate Trade Name: ACIDE TRANEXAMIQUE MYLAN 0,5 g/ 5 mL, solution injectable INN or Proposed INN: TRANEXAMIC ACID Other descriptive name: TRANEXAMIC ACID | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 315 | Phase 3 | France | ||
| 9 | NCT04596319 (ClinicalTrials.gov) | December 22, 2020 | 15/10/2020 | Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis | A Phase 1b/2a, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of AP-PA02 Multi-Phage Therapeutic Candidate for Inhalation in Subjects With Cystic Fibrosis and Chronic Pulmonary Pseudomonas Aeruginosa (Pa) Infection | Cystic Fibrosis;Pseudomonas Aeruginosa;Pseudomonas;Lung Infection;Lung Infection Pseudomonal | Biological: AP-PA02;Other: Placebo | Armata Pharmaceuticals, Inc. | Cystic Fibrosis Foundation | Active, not recruiting | 18 Years | N/A | All | 29 | Phase 1/Phase 2 | United States |
| 10 | NCT04467957 (ClinicalTrials.gov) | November 15, 2020 | 19/6/2020 | Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic Fibrosis | Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic Fibrosis | Cystic Fibrosis | Drug: Initiation of CFTR Modulator;Drug: Hyperpolarized Xenon 129 | Children's Hospital Medical Center, Cincinnati | NULL | Active, not recruiting | 6 Years | 21 Years | All | 26 | Phase 4 | United States |
| 11 | NCT02748798 (ClinicalTrials.gov) | November 10, 2020 | 19/4/2016 | Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung Disorders | Developing Optimal Parameters for Hyperpolarized Noble Gas (3He and 129Xe) and Inert Fluorinated Gas Magnetic Resonance Imaging of Lung Disorders | Lung Transplant;Lung Resection;Lung Cancer;Asthma;Cystic Fibrosis;Chronic Obstructive Pulmonary Disease;Emphysema;Mesothelioma;Asbestosis;Pulmonary Embolism;Interstitial Lung Disease;Pulmonary Fibrosis;Bronchiectasis;Seasonal Allergies;Cold Virus;Lung Infection;Pulmonary Hypertension;Pulmonary Dysplasia;Obstructive Sleep Apnea | Drug: HP 3He;Drug: HP 129Xe;Drug: PFP;Drug: SF6;Device: 129Xe Small and Large Human Lung Coil;Device: 3He Human Lung Coil;Device: PFP and SF6 Human Lung Coil | Thunder Bay Regional Research Institute | Thunder Bay Regional Health Sciences Centre;St. Joseph's Care Group;Lakehead University | Recruiting | 18 Years | N/A | All | 160 | Early Phase 1 | Canada |
| 12 | NCT04058210 (ClinicalTrials.gov) | July 21, 2020 | 13/8/2019 | VX-445/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients Heterozygous for F508del Mutation and a Minimal Function Mutation (F/MF Genotypes) | VX-445/TEZ/IVA Triple Combination Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function CFTR Mutation | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Approved for marketing | 12 Years | N/A | All | NULL | ||
| 13 | NCT03988816 (ClinicalTrials.gov) | December 6, 2019 | 14/6/2019 | Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Bronchiectasis | Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Non-cystic Fibrosis Bronchiectasis: a Cross-over, Unicentric, Double-blind and Placebo-controlled Study | Bronchiectasis Adult | Drug: Roflumilast;Drug: Placebo oral tablet | University of Sao Paulo General Hospital | FAPESP - Fundação de Apoio à Pesquisa do Estado de São Paulo | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | Brazil |
| 14 | NCT03924947 (ClinicalTrials.gov) | November 6, 2019 | 18/4/2019 | A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | A Phase 4 Study to Compare US Marketed Creon Drug Product With Drug Product Manufactured With a Modernized Process at an Alternate Manufacturing Site and With Drug Product Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Subjects With EPI Due to Cystic Fibrosis | Cystic Fibrosis | Drug: Pancrelipase | AbbVie | NULL | Completed | 12 Years | N/A | All | 36 | Phase 4 | United States;Spain |
| 15 | NCT04176328 (ClinicalTrials.gov) | October 25, 2019 | 8/11/2019 | Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis Patients | An Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Teicoplanin Sandoz 200 mg powder and solvent for solution for injection or infusion or oral solution. | Neupharma Srl | Sintesi Research Srl;Aptuit Srl;Pari Pharma GmbH | Completed | 18 Years | N/A | All | 12 | Phase 1 | Italy |
| 16 | NCT03912233 (ClinicalTrials.gov) | April 30, 2019 | 10/4/2019 | A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis | Drug: VX-121;Drug: TEZ;Drug: VX-561;Drug: TEZ/IVA;Drug: IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 87 | Phase 2 | United States;Germany;Netherlands;Portugal;United Kingdom |
| 17 | NCT03911713 (ClinicalTrials.gov) | April 17, 2019 | 9/4/2019 | A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis | Drug: VX-561;Drug: IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 77 | Phase 2 | United States;Australia;Belgium;Germany;Ireland;Netherlands;United Kingdom |
| 18 | NCT03795363 (ClinicalTrials.gov) | April 10, 2019 | 28/12/2018 | Orkambi Treatment in 2 to 5 Year Old Children With CF | Nutritional Impact of Orkambi Treatment in 2 to 5 Year Old Children Homozygous for F508del Mutations | Cystic Fibrosis | Drug: Orkambi | Children's Hospital of Philadelphia | Vertex Pharmaceuticals Incorporated | Completed | 2 Years | 5 Years | All | 28 | United States | |
| 19 | NCT03870841 (ClinicalTrials.gov) | April 3, 2019 | 24/10/2018 | The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic Fibrosis | An Open-label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Inhaled PC945 in Adult Cystic Fibrosis (CF) Patients With Persistent Pulmonary Aspergillus Fumigatus Infection | Aspergillosis;Cystic Fibrosis | Drug: PC945 | Pulmocide Ltd | NULL | Terminated | 18 Years | N/A | All | 4 | Phase 2 | United Kingdom |
| 20 | NCT03724955 (ClinicalTrials.gov) | April 2019 | 29/10/2018 | Pilot E2 for Hypogonadal Women With CFBD | Pilot Study Evaluating the Effects of Estradiol for Hypogonadal Women With Cystic Fibrosis and Osteopenia | Cystic Fibrosis Related Bone Disease | Drug: Estradiol 2 mg;Other: Placebo | Emory University | NULL | Withdrawn | 18 Years | N/A | Female | 0 | Phase 4 | United States |
| 21 | NCT03624101 (ClinicalTrials.gov) | December 1, 2018 | 7/8/2018 | Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon Mutations | Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon Mutations | Cystic Fibrosis | Drug: Trikafta;Drug: symdeko/Trikafta;Drug: Ivacaftor/Trikafta | University of Alabama at Birmingham | NULL | Recruiting | 18 Years | N/A | All | 2 | Phase 4 | United States |
| 22 | NCT03265288 (ClinicalTrials.gov) | October 10, 2018 | 21/2/2017 | Study of LAU-7b in the Treatment of Cystic Fibrosis in Adults | APPLAUD: A Double-Blind, Randomized, Placebo-Controlled, Phase II Study of the Efficacy and Safety of LAU-7b in the Treatment of Cystic Fibrosis in Adults | Cystic Fibrosis | Drug: LAU-7b;Drug: Placebo oral capsule | Laurent Pharmaceuticals Inc. | Cystic Fibrosis Foundation | Completed | 18 Years | N/A | All | 166 | Phase 2 | United States;Australia;Canada |
| 23 | EUCTR2018-000098-61-GB (EUCTR) | 22/06/2018 | 01/06/2018 | A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of the combination of GLPG3067, GLPG2222 and GLPG2737 in adult patients with cystic fibrosis | A Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered combination of GLPG3067, GLPG2222 and GLPG2737, in adult subjects with cystic fibrosis homozygous or heterozygous for F508del CFTR | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG3067 Product Code: G914167 INN or Proposed INN: Not applicable Other descriptive name: GLPG3067 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2737 Product Code: G1117337 INN or Proposed INN: Not applicable Other descriptive name: GLPG2737 Product Name: GLPG2737 Product Code: G1117337 INN or Proposed INN: Not applicable Other descriptive name: GLPG2737 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 144 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;France;United States;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;New Zealand;United Kingdom | ||
| 24 | NCT03537651 (ClinicalTrials.gov) | April 25, 2018 | 15/5/2018 | A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects With an F508del CFTR Mutation | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 6 Years | N/A | All | 130 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Poland;Switzerland;United Kingdom |
| 25 | NCT03492567 (ClinicalTrials.gov) | April 25, 2018 | 3/4/2018 | Study of Circulating Blood Cell Monocytes as Predictive Biomarker of Bone Cystic Fibrosis Disease. Impact of CFTR Correctors. | Study of Circulating Monocytes as Predictive Biomarker of Osteoclastogenesis in Cystic Fibrosis-related Bone Loss. Impact of CFTR Correctors. | Cystic Fibrosis | Biological: Blood test | Assistance Publique - Hôpitaux de Paris | Vaincre la Mucoviscidose | Completed | 18 Years | N/A | All | 25 | N/A | France |
| 26 | NCT03527095 (ClinicalTrials.gov) | April 5, 2018 | 4/5/2018 | A Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects | A Phase 1, Open-label, Randomised, Cross Over Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects Following Single Doses | Cystic Fibrosis | Drug: FDL169 | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | 55 Years | All | 11 | Phase 1 | United Kingdom |
| 27 | NCT03489629 (ClinicalTrials.gov) | April 3, 2018 | 29/3/2018 | STaph Aureus Resistance-Treat Early and Repeat (STAR-TER) | STaph Aureus Resistance-Treat Early and Repeat (STAR-TER) | Cystic Fibrosis | Drug: Trimethoprim Sulfamethoxazole (TMP/SMX);Drug: Minocycline;Drug: Mupirocin;Drug: Chlorhexidine Gluconate;Behavioral: Environmental Decontamination | University of North Carolina, Chapel Hill | University of Washington;Cook Children's Medical Center;Indiana University;University of Michigan;University of Texas Southwestern Medical Center;St. Louis Children's Hospital | Recruiting | 2 Years | 45 Years | All | 42 | Phase 2 | United States |
| 28 | EUCTR2017-002181-42-DE (EUCTR) | 27/10/2017 | 28/07/2017 | GLPG2737 on top of Orkambi in subjects with cystic fibrosis | A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2737 in Orkambi-treated subjects with cystic fibrosis homozygous for the F508del mutation | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2737 Product Code: G1117337 INN or Proposed INN: Not applicable Other descriptive name: GLPG2737 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Germany | ||
| 29 | NCT03278314 (ClinicalTrials.gov) | August 27, 2017 | 6/9/2017 | Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis | Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis | Cystic Fibrosis | Drug: tezacaftor/ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Approved for marketing | 12 Years | N/A | All | NULL | ||
| 30 | NCT03277196 (ClinicalTrials.gov) | August 16, 2017 | 6/9/2017 | A Study to Evaluate the Safety of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation | A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation | Cystic Fibrosis | Drug: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 0 Months | 24 Months | All | 86 | Phase 3 | United States;Australia;Canada;Germany;Ireland;United Kingdom |
| 31 | EUCTR2017-001379-21-GB (EUCTR) | 01/08/2017 | 20/07/2017 | A study to assess the safety and pharmacodynamics of long-term ivacaftor treatment in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs). | A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 3 | United States;Canada;Ireland;Germany;United Kingdom | ||
| 32 | NCT02819856 (ClinicalTrials.gov) | July 21, 2017 | 16/6/2016 | SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Cystic Fibrosis (CF) Patients With Acute Pulmonary Exacerbation (APE) Receiving IV Tobramycin at Risk for Ototoxicity | Ototoxicity | Drug: Placebo;Drug: SPI-1005 Ebselen 200mg Capsule x1;Drug: SPI-1005 Ebselen 200mg Capsule x2;Drug: SPI-1005 Ebselen 200mg Capsule x3 | Sound Pharmaceuticals, Incorporated | Medical University of South Carolina;Cystic Fibrosis Foundation | Enrolling by invitation | 18 Years | N/A | All | 80 | Phase 2 | United States |
| 33 | EUCTR2016-004477-40-ES (EUCTR) | 31/05/2017 | 10/03/2017 | A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both alleles | A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation | Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Serbia;United States;Belgium;Spain;Netherlands;United Kingdom | ||
| 34 | EUCTR2016-004477-40-GB (EUCTR) | 26/05/2017 | 06/02/2017 | A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both alleles | A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation | Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Belgium;Spain;Netherlands;United Kingdom | ||
| 35 | EUCTR2016-004477-40-BE (EUCTR) | 08/05/2017 | 21/02/2017 | A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both alleles | A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation | Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United States;Serbia;Spain;Belgium;Netherlands;United Kingdom | ||
| 36 | NCT03051490 (ClinicalTrials.gov) | April 28, 2017 | 9/2/2017 | RESULT: Reliable, Emergent Solution Using Liprotamase Treatment | A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | Exocrine Pancreatic Insufficiency;Cystic Fibrosis | Drug: Liprotamase;Drug: porcine PERT | Anthera Pharmaceuticals | NULL | Unknown status | 7 Years | N/A | All | 140 | Phase 3 | United States;Hungary;Israel;Lithuania;Poland;Spain;United Kingdom |
| 37 | NCT03140527 (ClinicalTrials.gov) | April 10, 2017 | 27/4/2017 | Study Assessing the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis | A Multi-Center, Randomized, Placebo-Controlled, Phase 1, Two-Part Study Designed to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis | Healthy Volunteer;Cystic Fibrosis | Drug: PTI-801;Drug: Placebo;Drug: PTI-808 | Proteostasis Therapeutics, Inc. | NULL | Completed | 18 Years | N/A | All | 171 | Phase 1 | United States;Canada;Denmark;Germany;Sweden;Portugal |
| 38 | EUCTR2016-004477-40-NL (EUCTR) | 10/04/2017 | 14/02/2017 | A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both alleles | A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation | Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Serbia;United States;Belgium;Spain;Netherlands;United Kingdom | ||
| 39 | NCT03104855 (ClinicalTrials.gov) | April 3, 2017 | 17/2/2017 | Clearance of 25-hydroxyvitamin D in Cystic Fibrosis | Clearance of 25-hydroxyvitamin D in Cystic Fibrosis | Cystic Fibrosis | Drug: d6-25-hydroxyvitamin D3 | University of Washington | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Active, not recruiting | 18 Years | N/A | All | 10 | Phase 1 | United States |
| 40 | EUCTR2016-002837-31-CZ (EUCTR) | 04/01/2017 | 24/10/2016 | A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutation | A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom | ||
| 41 | EUCTR2016-002837-31-DE (EUCTR) | 29/12/2016 | 24/10/2016 | A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutation | A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation - Albatross | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom | ||
| 42 | EUCTR2016-002837-31-BE (EUCTR) | 16/12/2016 | 24/10/2016 | A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutation | A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom | ||
| 43 | EUCTR2016-002837-31-GB (EUCTR) | 05/12/2016 | 17/10/2016 | A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutation | A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 35 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom | ||
| 44 | EUCTR2016-002837-31-IE (EUCTR) | 02/12/2016 | 04/10/2016 | A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutation | A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom | ||
| 45 | EUCTR2015-003291-77-DE (EUCTR) | 25/05/2016 | 11/11/2015 | A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutation | A phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation | Cystic fibrosis with the G551D mutation MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | Czech Republic;Ireland;Australia;Germany;United Kingdom | ||
| 46 | NCT02850692 (ClinicalTrials.gov) | April 18, 2016 | 16/6/2016 | Portal Hypertension and Systemic Endothelial Function | Portal Hypertension and Systemic Endothelial Function: Investigation of Systemic Endothelial Dysfunction in Case of Portal Hypertension Associated With Cystic Fibrosis. | Cystic Fibrosis;Portal Hypertension | Other: measure of endothelial function;Biological: Blood sample;Other: Hepatic elastography;Diagnostic Test: Injected abdominal CT | Hopital Foch | NULL | Recruiting | 18 Years | N/A | All | 60 | N/A | France |
| 47 | NCT02724527 (ClinicalTrials.gov) | April 2016 | 11/3/2016 | Study of Cavosonstat (N91115) in CF Patients Who Are Heterozygous for F508del-CFTR and a Gating Mutation and Being Treated With Ivacaftor | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of N91115 for Efficacy and Safety in Patients With CF Heterozygous for F508del-CFTR + Gating Mutation Being Treated With Ivacaftor | Cystic Fibrosis | Drug: Cavosonstat;Drug: Placebo | Nivalis Therapeutics, Inc. | NULL | Active, not recruiting | 18 Years | N/A | Both | 19 | Phase 2 | United States |
| 48 | NCT02767297 (ClinicalTrials.gov) | April 2016 | 5/5/2016 | Bioavailability and Pharmacokinetics Study of FDL169 in Healthy Subjects and Subjects With Cystic Fibrosis | A Three-Part Phase 1b Bioavailability and Pharmacokinetics Study of Two Formulations of FDL169 in Healthy Subjects and Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: FDL169 | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | N/A | Both | 46 | Phase 1/Phase 2 | United Kingdom |
| 49 | EUCTR2015-003292-30-NL (EUCTR) | 26/02/2016 | 02/12/2015 | A study looking at the safety of the drug GLPG1837 in patients with cysticfibrosis and the S1251N mutation | A phase IIa, open-label study of two doses of GLPG1837 in subjects with cystic fibrosis and the S1251N mutation. | Cystic fibrosis with the S1251N mutation MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | Belgium;Netherlands | ||
| 50 | EUCTR2015-003291-77-IE (EUCTR) | 03/02/2016 | 03/12/2015 | A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutation | A phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation | Cystic fibrosis with the G551D mutation MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | Czech Republic;Ireland;Australia;Germany;United Kingdom | ||
| 51 | EUCTR2015-003291-77-GB (EUCTR) | 02/02/2016 | 03/11/2015 | A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutation | A phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation | Cystic fibrosis with the G551D mutation MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 32 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Ireland;Australia;Germany;United Kingdom | ||
| 52 | NCT02840136 (ClinicalTrials.gov) | February 2016 | 18/7/2016 | LC-MS/MS Based Method Development for the Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients | Optimisation, Valorisation and Application of UPLC-MS/MS Based Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients - Part 3: Non-blank Sputum Samples for Method Optimisation and Validation | Cystic Fibrosis | Drug: Piperacillin-tazobactam combination product;Drug: Meropenem;Drug: Ceftazidime | University Ghent | King Baudouin Foundation;Belgische Vereniging voor Strijd tegen Mucoviscidose | Suspended | 12 Years | N/A | All | 40 | N/A | Belgium |
| 53 | EUCTR2015-003291-77-CZ (EUCTR) | 26/01/2016 | 16/11/2015 | A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutation | A phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation | Cystic fibrosis with the G551D mutation MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | Czech Republic;Ireland;Australia;Germany;United Kingdom | ||
| 54 | EUCTR2015-003292-30-BE (EUCTR) | 18/01/2016 | 26/11/2015 | A study looking at the safety of the drug GLPG1837 in patients with cysticfibrosis and the S1251N mutation | A phase IIa, open-label study of two doses of GLPG1837 in subjects with cystic fibrosis and the S1251N mutation. | Cystic fibrosis with the S1251N mutation MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | Belgium;Netherlands | ||
| 55 | NCT02449031 (ClinicalTrials.gov) | May 5, 2015 | 4/5/2015 | Observational Study in Cystic Fibrosis Patients Using TOBI® Podhaler™ or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs | A Prospective Observational Study in Cystic Fibrosis Patients With Chronic Respiratory Pseudomonas Aeruginosa Infection Treated With TOBI® Podhaler™ (Tobramycin Inhalation Powder) or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs | Pseudomonas Aeruginosa in Cystic Fibrosis | Drug: TOBI Podhaler;Drug: TOBI;Drug: Bethkis;Drug: Cayston | Mylan Inc. | Cystic Fibrosis Foundation | Active, not recruiting | 6 Years | N/A | All | 260 | United States | |
| 56 | NCT02445053 (ClinicalTrials.gov) | April 2015 | 11/5/2015 | Observational Study of Outcomes in Cystic Fibrosis Patients With Selected Gating Mutations on a CFTR Allele (The VOCAL Study) | Observational Study of Outcomes in Cystic Fibrosis Patients With Selected Gating Mutations on a CFTR Allele (The VOCAL Study) | Cystic Fibrosis | Drug: ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Completed | 6 Years | N/A | All | 75 | Italy;Netherlands;United Kingdom | |
| 57 | NCT02343445 (ClinicalTrials.gov) | April 2015 | 13/1/2015 | Clearing Lungs With Epithelial Sodium Channel (ENaC) Inhibition in Cystic Fibrosis (CF) | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of P-1037 Solution for Inhalation in Patients With Cystic Fibrosis (CF) | Cystic Fibrosis | Drug: P-1037;Drug: Hypertonic Saline;Drug: Saline | Parion Sciences | Vertex Pharmaceuticals Incorporated | Completed | 12 Years | 80 Years | All | 142 | Phase 2 | United States |
| 58 | EUCTR2014-004519-35-GB (EUCTR) | 23/02/2015 | 08/12/2014 | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CREON IR INN or Proposed INN: NOT APPLICABLE Other descriptive name: PANCREATIN (PAncreas Powder) Trade Name: Kreon 25 000 Product Name: Creon® 25,000 INN or Proposed INN: not assigned Other descriptive name: PANCREATIN (Pancreas Powder) | Abbott Laboratories GmbH | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | Czech Republic;Hungary;Spain;United Kingdom | ||
| 59 | EUCTR2014-004519-35-CZ (EUCTR) | 18/02/2015 | 19/11/2014 | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CREON IR INN or Proposed INN: NOT APPLICABLE Other descriptive name: PANCREATIN (PAncreas Powder) Trade Name: Kreon 25 000 Product Name: Creon® 25,000 INN or Proposed INN: not assigned Other descriptive name: PANCREATIN (Pancreas Powder) | Abbott Laboratories GmbH | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | Hungary;Czech Republic;Spain;United Kingdom | ||
| 60 | EUCTR2014-004519-35-ES (EUCTR) | 30/01/2015 | 04/12/2014 | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: KREON de Liberación Inmediata INN or Proposed INN: NOT APPLICABLE Other descriptive name: PANCREATINA (Páncreas Polvo Trade Name: Kreon 25 000 Product Name: Kreon® 25,000 INN or Proposed INN: not assigned Other descriptive name: PANCREATINA (Páncreas Polvo) | Abbott Laboratories GmbH | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | Czech Republic;Hungary;Spain;United Kingdom | ||
| 61 | EUCTR2014-004519-35-HU (EUCTR) | 09/01/2015 | 12/11/2014 | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CREON IR INN or Proposed INN: NOT APPLICABLE Other descriptive name: PANCREATIN (Pancreas Powder) Trade Name: Kreon 25 000 Product Name: Creon® 25,000 INN or Proposed INN: not assigned Other descriptive name: PANCREATIN (Pancreas Powder) | Abbott Laboratories GmbH | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | Czech Republic;Hungary;Spain;United Kingdom | ||
| 62 | NCT02106832 (ClinicalTrials.gov) | April 30, 2014 | 4/4/2014 | Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE) | Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis. | Bronchiectasis | Drug: Ciprofloxacin (BAYQ3939) dry powder for inhalation;Drug: Placebo | Bayer | Novartis | Completed | 18 Years | N/A | All | 521 | Phase 3 | United States;Argentina;Australia;Austria;Brazil;Bulgaria;China;Czechia;Germany;Hong Kong;Korea, Republic of;Latvia;Lithuania;Netherlands;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Taiwan;Thailand;Turkey;Czech Republic |
| 63 | NCT02088216 (ClinicalTrials.gov) | April 1, 2014 | 5/3/2014 | Effect of Long-term, High-dose N-acetylcysteine on Exacerbations of Bronchiectaisis | Effect of N-acetylcysteine on Exacerbations of Bronchiectasis (BENE): a Randomized Controlled Trial | Non-Cystic Fibrosis Bronchiectasis | Drug: N-acetylcysteine;Other: On-demand treatment | Qilu Hospital of Shandong University | NULL | Completed | 18 Years | 80 Years | All | 161 | N/A | China |
| 64 | NCT02141958 (ClinicalTrials.gov) | April 2014 | 13/5/2014 | Safety Study of Fenretinide in Adult Patients With Cystic Fibrosis | An Adaptive Phase I Intra-patient Dose Escalation Study of Fenretinide in Adult Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Fenretinide;Drug: Placebo | Elias Matouk | NULL | Completed | 18 Years | N/A | Both | 15 | Phase 1 | Canada |
| 65 | NCT02057458 (ClinicalTrials.gov) | April 2014 | 4/2/2014 | Blood Flow and Vascular Function in Cystic Fibrosis | Role of Blood Flow and Vascular Function on Exercise Capacity in Cystic Fibrosis | Cystic Fibrosis | Drug: Sildenafil (Acute-1 hour);Drug: Sildenafil (Subchronic-4 weeks);Drug: Placebo | Augusta University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 18 Years | N/A | All | 19 | Phase 2 | United States |
| 66 | NCT01991028 (ClinicalTrials.gov) | April 2014 | 18/11/2013 | A Study to Investigate Lung Deposition of Radiolabelled OligoG | An Open Label, Randomised, Two-way Crossover Scintigraphic Study to Investigate Lung Deposition of Radiolabelled OligoG Delivered as a Dry Powder and as a Nebulised Solution in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Radiolabelled OligoG CF-5/20 DPI;Drug: Radiolabelled OligoG CF-5/20 6% Solution | Bio-Images Research Ltd | AlgiPharma AS | Completed | 18 Years | N/A | Both | 10 | Phase 2 | United Kingdom |
| 67 | NCT02113397 (ClinicalTrials.gov) | April 2014 | 9/4/2014 | Evaluation of Inhaled Antibiotics on Bacterial Diversity and Richness in the Cystic Fibrosis Lung | Comparative Evaluation of Bacterial Diversity and Richness in CF Lung in Patients Who Use Cycled Every Other Month Tobramycin Inhalation Powder (TOBI™ Podhaler™) Or Continuous Alternating Therapy With Tobramycin Inhalation Powder (TOBI™ Podhaler™) and Inhaled Colistimethate | Cystic Fibrosis | Drug: TOBI™ Podhaler™ 112 mg inhaled twice daily;Drug: Colistimethate 75 mg inhaled two times daily | Dartmouth-Hitchcock Medical Center | Novartis Pharmaceuticals | Terminated | 12 Years | 75 Years | All | 1 | United States | |
| 68 | NCT02084043 (ClinicalTrials.gov) | March 2014 | 8/3/2014 | In Vitro Assessment of a Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation | In Vitro Comparison of Continuous and Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation: Analysis of Inhaled and Lost Doses. | Respiratory Diseases;Lung Diseases;Cystic Fibrosis;COPD;Asthma | Drug: Nebulization of Amikacin during NIV (RR: 15 cycles/minute);Drug: Nebulization of Amikacin during NIV (RR: 25 cycles/minute) | University Hospital St Luc, Brussels | Université Catholique de Louvain;University of Applied Sciences of Western Switzerland;School of Gestion and Engineering Vaud, Switzerland | Completed | N/A | N/A | Both | 3 | N/A | Belgium;Switzerland |
| 69 | EUCTR2013-002819-10-ES (EUCTR) | 26/12/2013 | 12/11/2013 | A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ? 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ? 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: KREON N 25000 INN or Proposed INN: Not applicable Other descriptive name: PANCREATIN Trade Name: Kreon 25000 INN or Proposed INN: not assigned Other descriptive name: PANCREATINA | Abbott Laboratories GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | Hungary;Spain;Russian Federation | |||
| 70 | EUCTR2013-002819-10-HU (EUCTR) | 29/11/2013 | 14/10/2013 | A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects = 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects = 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CREON N 25000 INN or Proposed INN: not applicable Other descriptive name: PANCREATIN Trade Name: Creon 25000 INN or Proposed INN: not assigned Other descriptive name: PANCREATIN | Abbott Laboratories GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | Hungary;Spain;Russian Federation | |||
| 71 | EUCTR2009-012842-21-HU (EUCTR) | 27/06/2013 | 10/05/2013 | Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis | Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis | Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Kreon 25 000 Product Name: KREON 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Trade Name: Zenpep Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN | Aptalis Pharma US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 86 | Hungary;Bulgaria;Germany;Italy;United Kingdom | |||
| 72 | NCT01807949 (ClinicalTrials.gov) | April 2013 | 4/3/2013 | A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Drug: Placebo;Drug: Lumacaftor Plus Ivacaftor Combination;Drug: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | 65 Years | All | 563 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Spain;United Kingdom |
| 73 | NCT01818544 (ClinicalTrials.gov) | April 2013 | 8/3/2013 | Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) Bronchiectasis | A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY85-8501 in Patients With Non-Cystic Fibrosis Bronchiectasis | Bronchiectasis | Drug: BAY85-8501;Drug: Placebo | Bayer | NULL | Completed | 18 Years | N/A | Both | 94 | Phase 2 | France;Germany;Italy;Spain;United Kingdom |
| 74 | EUCTR2009-012842-21-BE (EUCTR) | 19/11/2012 | 14/05/2012 | Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis | Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis | Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Kreon 25 000 Product Name: KREON 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Trade Name: Zenpep Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREASLIPASE | Aptalis Pharma US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 86 | Phase 3 | Hungary;Belgium;Bulgaria;Germany;Italy;United Kingdom | ||
| 75 | NCT01641393 (ClinicalTrials.gov) | June 2012 | 10/7/2012 | Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis. | A Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in the Treatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis | Exocrine Pancreatic Insufficiency: Cystic Fibrosis | Drug: EUR-1008 25,000 Units;Drug: Kreon 25,000 Units | Aptalis Pharma | NULL | Completed | 12 Years | N/A | Both | 96 | Phase 3 | Belgium;Bulgaria;France;Germany;Italy;Poland;United Kingdom |
| 76 | NCT01621867 (ClinicalTrials.gov) | May 2012 | 14/6/2012 | Repeated Application of Gene Therapy in CF Patients | A Randomised, Double-blind, Placebo-controlled Phase 2B Clinical Trial of Repeated Application of Gene Therapy in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: pGM169/GL67A;Drug: Placebo | Imperial College London | University of Edinburgh;University of Oxford;Royal Brompton & Harefield NHS Foundation Trust | Completed | 12 Years | N/A | Both | 130 | Phase 2 | United Kingdom |
| 77 | NCT01270074 (ClinicalTrials.gov) | April 2012 | 23/12/2010 | Prevention of Bronchiectasis in Infants With Cystic Fibrosis | A Phase 3 Multi-centre Randomised Placebo-controlled Study of Azithromycin in the Primary Prevention of Radiologically-defined Bronchiectasis in Infants With Cystic Fibrosis. | Cystic Fibrosis;Bronchiectasis | Drug: Azithromycin;Drug: Placebo control | The University of Queensland | Telethon Kids Institute | Completed | 6 Weeks | 6 Months | All | 130 | Phase 3 | Australia;New Zealand |
| 78 | NCT01572194 (ClinicalTrials.gov) | April 2012 | 28/3/2012 | Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation (MUCO-IRC) | Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation. | Lung Transplantation;Cystic Fibrosis;Renal Failure | Biological: Urinary levels of PIIINP as a marker of changes in renal function | Nantes University Hospital | NULL | Terminated | 18 Years | N/A | All | 45 | N/A | France |
| 79 | EUCTR2011-004761-33-GB (EUCTR) | 08/03/2012 | 14/12/2011 | Repeated application of gene therapy in patients with cystic fibrosis | A randomised double-blind placebo-controlled Phase 2B clinical trial of repeated application of gene therapy in patients with cystic fibrosis - Repeated application of gene therapy in patients with CF v01-010204 | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: pGM169/GL67A Other descriptive name: pGM169/GL67A | Imperial College | NULL | Not Recruiting | Female: yes Male: yes | 130 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 80 | NCT01381289 (ClinicalTrials.gov) | June 2011 | 22/6/2011 | VX-770 Expanded Access Program | VX-770 Expanded Access Program (EAP) | Cystic Fibrosis | Drug: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | Approved for marketing | 6 Years | N/A | Both | N/A | NULL | |
| 81 | NCT01349192 (ClinicalTrials.gov) | April 2011 | 4/5/2011 | Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF) | Early MRSA Therapy in CF - Culture Based vs. Observant Therapy (Treat or Observe) (Star-TOO - STaph Aureus Resistance - Treat or Observe) | Cystic Fibrosis;Methicillin-resistant Staphylococcus Aureus | Drug: Rifampin;Drug: Trimethoprim/Sulfamethoxazole;Drug: Minocycline;Drug: Mupirocin;Drug: chlorhexidine gluconate oral rinse;Drug: 2% Chlorhexidine solution wipes;Behavioral: Environmental Decontamination | University of North Carolina, Chapel Hill | CF Therapeutics Development Network Coordinating Center;Seattle Children's Hospital;Washington University School of Medicine;University of Washington;University of Colorado, Denver;Baylor College of Medicine;University of Alabama at Birmingham;Cook Children's Medical Center;University of Michigan;University of Florida;University of Texas Southwestern Medical Center;Children's Hospital Medical Center, Cincinnati;St. Louis Children's Hospital | Terminated | 4 Years | 45 Years | All | 47 | Phase 2 | United States |
| 82 | NCT01313624 (ClinicalTrials.gov) | April 2011 | 10/3/2011 | Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis | A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection | Bronchiectasis | Drug: AZLI;Drug: Placebo | Gilead Sciences | NULL | Completed | 18 Years | N/A | All | 266 | Phase 3 | United States;Australia;Canada |
| 83 | NCT01337219 (ClinicalTrials.gov) | April 2011 | 13/4/2011 | Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaid® in Patients With Cystic Fibrosis | Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaide® in Patients With Cystic Fibrosis. | Cystic Fibrosis | Drug: Tobramycin | Erempharma | University of Lyon;Epidemiologie Pharmacologie Investigation Clinique Information medicale Mere Enfant (EPICIME);Clininfo;Hospices Civils de Lyon | Recruiting | 16 Years | N/A | Both | 36 | Phase 1/Phase 2 | France |
| 84 | NCT01315665 (ClinicalTrials.gov) | April 2011 | 14/3/2011 | Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation | Evaluation of the Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation, Measures of Oxidative Stress, and Neutrophil Migration to Mucosal Surfaces in Healthy and CF Subjects | Cystic Fibrosis | Dietary Supplement: Broccoli sprouts | University Hospitals Cleveland Medical Center | Cystic Fibrosis Foundation | Completed | 18 Years | 49 Years | All | 15 | N/A | United States |
| 85 | NCT01327703 (ClinicalTrials.gov) | April 2011 | 28/3/2011 | Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency | An Open-label, Multicenter, Randomized, Cross-over Study to Compare the Safety and Efficacy of PANZYTRAT® 25,000 to KREON® 25,000 in the Control of Steatorrhea in Subjects Aged 7 Years and Older With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI) | Exocrine Pancreatic Insufficiency;Cystic Fibrosis | Drug: Panzytrat® 25,000;Drug: Kreon® 25,000 | Forest Laboratories | NULL | Completed | 7 Years | N/A | All | 87 | Phase 4 | Germany;Poland |
| 86 | NCT01347190 (ClinicalTrials.gov) | April 2011 | 3/5/2011 | Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis | A Double Blind, Randomized, Placebo Controlled, Single Dose, Phase I Study of the Safety and Tolerability of Alpha1 Proteinase Inhibitor (Human) Inhalation Solution (CR002) in Subjects With Cystic Fibrosis | Cystic Fibrosis | Biological: CR002 Liquid API;Biological: Placebo | CSL Behring | NULL | Completed | 18 Years | 65 Years | Both | 25 | Phase 1 | Bulgaria;Hungary;Poland;United Kingdom |
| 87 | NCT01314716 (ClinicalTrials.gov) | April 2011 | 11/3/2011 | Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis | A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2) | Bronchiectasis | Drug: AZLI;Drug: Placebo | Gilead Sciences | NULL | Completed | 18 Years | N/A | All | 274 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom |
| 88 | EUCTR2009-012842-21-BG (EUCTR) | 24/02/2011 | 28/09/2010 | Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis | Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis | Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Kreon 25 000 Product Name: KREON 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Trade Name: Zenpep Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN | Aptalis Pharma US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 86 | France;Hungary;Belgium;Spain;Poland;Ireland;Romania;Bulgaria;Germany;United Kingdom;Italy | |||
| 89 | EUCTR2009-012842-21-DE (EUCTR) | 13/01/2011 | 13/07/2010 | Treatment of Exocrine Pancreatic Insufficiency in Subjects with Cystic Fibrosis | Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis | Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Kreon 25 000 Product Name: KREON 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN | Aptalis Pharma US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 86 | Hungary;Bulgaria;Germany;Italy;United Kingdom | |||
| 90 | EUCTR2009-012842-21-GB (EUCTR) | 20/09/2010 | 17/06/2010 | Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis | Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis | Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Kreon 25 000 Product Name: KREON 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Trade Name: Zenpep Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREASLIPASE | Aptalis Pharma US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 86 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Belgium;Bulgaria;Germany;Italy;United Kingdom | ||
| 91 | NCT01131507 (ClinicalTrials.gov) | July 2010 | 25/5/2010 | PR-018: An Open-Label, Safety Extension of Study PR-011 | A Multicenter, Open-Label, Safety Extension of Study PR-011 Titled: A Multicenter, Randomized, Open-Label, Crossover Study to Evaluate the Mode of Administration and Safety of EUR-1008 in Infants 1 to 12 Months of Age With Exocrine Pancreatic Insufficiency (EPI) Associated With Cystic Fibrosis (CF) | Cystic Fibrosis;Exocrine Pancreatic Insufficiency | Drug: EUR-1008 (APT-1008) | Forest Laboratories | NULL | Completed | N/A | 12 Months | All | 15 | Phase 4 | United States |
| 92 | NCT01100606 (ClinicalTrials.gov) | June 2010 | 31/3/2010 | A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age | A Multicenter, Randomized, Open-Label, Crossover Study to Evaluate the Mode of Administration and Safety of EUR-1008 in Infants 1 to 12 Months of Age With Exocrine Pancreatic Insufficiency (EPI) Associated With Cystic Fibrosis (CF) | Cystic Fibrosis;Exocrine Pancreatic Insufficiency | Drug: EUR-1008 (APT-1008) | Forest Laboratories | NULL | Completed | 1 Month | 12 Months | All | 15 | Phase 4 | United States |
| 93 | NCT01093521 (ClinicalTrials.gov) | April 2010 | 24/3/2010 | A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients | A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: 100 mg/m2 dose;Drug: 200 mg/m2 dose | University of Washington | Cystic Fibrosis Foundation | Completed | 18 Years | 55 Years | All | 20 | Phase 1 | United States |
| 94 | NCT01460836 (ClinicalTrials.gov) | April 2010 | 25/10/2011 | Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis | Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis | Cystic Fibrosis | Drug: Tobramycin solution for inhalation;Drug: Aztreonam lysine for inhalation | Novartis Pharmaceuticals | NULL | Completed | 6 Years | N/A | Both | N/A | NULL | |
| 95 | NCT01321905 (ClinicalTrials.gov) | April 2010 | 23/3/2011 | Prospective Intervention Study on Vitamin D in Patients With Cystic Fibrosis | 5-month Pilot Intervention Study on Vitamin D in Patients With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Supplementation with vitamin D2/D3 | Karolinska Institutet | Stockholm County Council, Sweden;Swedish Cystic Fibrosis Association | Recruiting | 6 Years | N/A | Both | 15 | Phase 2 | Sweden |
| 96 | NCT01082367 (ClinicalTrials.gov) | April 2010 | 5/3/2010 | Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years | Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients | Drug: TOBI;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 3 Months | 6 Years | All | 50 | Phase 3 | Canada;Egypt;France;Germany;Greece;Hungary;Italy;Romania;Russian Federation;Switzerland;Poland;United States |
| 97 | NCT00763477 (ClinicalTrials.gov) | April 2010 | 30/9/2008 | Ghrelin in Cystic Fibrosis | The Effect of Ghrelin on Appetite and Immune Function in Patients With Cystic Fibrosis | Cystic Fibrosis | Biological: ghrelin | Papworth Hospital | NULL | Recruiting | 18 Years | 80 Years | Both | 20 | N/A | United Kingdom |
| 98 | NCT01499914 (ClinicalTrials.gov) | November 2009 | 21/11/2011 | Cohort Study Evaluating the Clinical Effectiveness, Safety and Immunogenicity to the Pandemic Influenza Vaccination | Cohort Study Evaluating the Clinical Effectiveness, Safety and Immunogenicity to the Pandemic Influenza Vaccination in Patients With Cystic Fibrosis and, Where Applicable, the Clinical Expression of Influenza A (H1N1) | Cystic Fibrosis With Gastrointestinal Manifestation | Biological: influenza vaccination | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 6 Months | N/A | Both | 439 | Phase 4 | France |
| 99 | NCT00989807 (ClinicalTrials.gov) | September 2009 | 2/10/2009 | Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis | Expanded Access for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease Progression | Cystic Fibrosis;Pseudomonas Aeruginosa | Drug: Aztreonam lysine | Gilead Sciences | NULL | Approved for marketing | 6 Years | N/A | Both | N/A | Canada | |
| 100 | ChiCTR-TRC-13003979 | 2009-05-07 | 2013-10-28 | Application of roxithromycin in patients with bronchiectasis in stable condition | Effect of low-dose, long-term roxithromycin on airway imflammation and remodeling of stable non-cystic fibrosis bronchiectasis | Bronchietasis | Roxithromycin group:The patients received oral roxithromycin in roxithromycin group;Control group:The patients received no drug in control group; | First Affiliated Hospital of Guangxi Medical University | NULL | Completed | 18 | 70 | Both | Roxithromycin group:26;Control group:26; | China | |
| 101 | NCT00843817 (ClinicalTrials.gov) | April 2009 | 12/2/2009 | RhDNase and Biodistribution of PMN Serine Proteases in Cystic Fibrosis Sputum | RhDNase Effect on Biodistribution of PMN Serine Proteases in Cystic Fibrosis Sputum | Cystic Fibrosis | Drug: Pulmozyme | University Hospital, Tours | NULL | Completed | 18 Years | N/A | All | 15 | Phase 4 | France |
| 102 | NCT00840333 (ClinicalTrials.gov) | April 2009 | 5/2/2009 | Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Pediatric (CF) Patients | A Phase 1B, Multi-Center, Open Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MP-376 Inhalation Solution Given Daily for 14 Days to Stable Pediatric Cystic Fibrosis Patients. | Cystic Fibrosis | Drug: MP-376 (Levofloxacin solution for Inhalation) | Horizon Pharma USA, Inc. | NULL | Completed | 6 Years | 16 Years | All | 27 | Phase 1 | United States |
| 103 | NCT00880100 (ClinicalTrials.gov) | April 2009 | 9/4/2009 | Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF) | Efficacy and Safety of Ultrase MT12 in the Control of Steatorrhea in Cystic Fibrosis (CF) and Pancreatic Insufficient (PI) Children Aged 2 to 6 Years Old | Cystic Fibrosis;Pancreatic Insufficiency | Drug: Ultrase® MT12 | Forest Laboratories | NULL | Completed | 2 Years | 6 Years | All | 49 | Phase 3 | United States |
| 104 | NCT00885365 (ClinicalTrials.gov) | April 2009 | 20/4/2009 | A Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI® | A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: tobramycin / Bramitob;Drug: tobramycin / TOBI | Chiesi Farmaceutici S.p.A. | NULL | Completed | 6 Years | N/A | All | 324 | Phase 3 | Czechia;France;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine;Czech Republic |
| 105 | NCT00775528 (ClinicalTrials.gov) | April 2009 | 17/10/2008 | Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | An Open Label, Multi-center, Study to Assess the Safety and Tolerability of Pancrelipase Delayed Release Capsules in Infants and Children Less Than 7 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Cystic Fibrosis;Pancreatic Exocrine Insufficiency | Drug: Pancrelipase Delayed Release | Solvay Pharmaceuticals | NULL | Completed | 1 Month | 6 Years | All | 19 | Phase 3 | United States |
| 106 | NCT00709280 (ClinicalTrials.gov) | April 2009 | 1/7/2008 | Infant Study of Inhaled Saline in Cystic Fibrosis | Infant Study of Inhaled Saline in Cystic Fibrosis | Cystic Fibrosis | Drug: 7% Hypertonic Saline (HS);Drug: 0.9% Isotonic Saline (IS) | CF Therapeutics Development Network Coordinating Center | Cystic Fibrosis Foundation Therapeutics;National Heart, Lung, and Blood Institute (NHLBI) | Completed | 4 Months | 59 Months | Both | 321 | N/A | United States;Canada |
| 107 | NCT00700050 (ClinicalTrials.gov) | April 2008 | 16/6/2008 | Modulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis Airways | Modulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis Airways - A Pilot Study | Cystic Fibrosis | Drug: Hypertonic saline | The Hospital for Sick Children | Unity Health Toronto | Active, not recruiting | 14 Years | 28 Years | All | 80 | Canada | |
| 108 | NCT01323101 (ClinicalTrials.gov) | April 2008 | 15/2/2011 | Doxycycline Effects on Inflammation in Cystic Fibrosis | Effect of Doxycycline on Sputum Biomarkers of Inflammation and Lung Epithelial Repair in Patients With Cystic Fibrosis. | Cystic Fibrosis | Drug: Doxycycline;Other: No doxycycline | University of Southern California | NULL | Completed | 18 Years | N/A | All | 21 | Phase 4 | United States |
| 109 | EUCTR2006-001254-27-FR (EUCTR) | 30/11/2006 | 25/08/2006 | Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus | Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus | Patients atteints de mucoviscidose, chez lesquels un diagnostic de diabète a été fait par hyperglycémie provoquée orale (HGPO) MedDRA version: 8.1;Level: PT;Classification code 10012594;Term: DIABETES | Trade Name: NovoNorm 0.5 mg Product Name: NovoNorm 0.5 mg INN or Proposed INN: Répaglinide Trade Name: Actrapid Penfill 100UI/ml Product Name: Actrapid Penfill 100UI/ml INN or Proposed INN: Insuline humaine recombinante Trade Name: NovoNorm 1 mg Product Name: NovoNorm 1 mg INN or Proposed INN: Répaglinide Trade Name: NovoNorm 2 mg Product Name: NovoNorm 2 mg INN or Proposed INN: Répaglinide | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 110 | NCT00981214 (ClinicalTrials.gov) | May 2006 | 21/9/2009 | Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency | An Open-Label Study to Evaluate the Efficacy and Safety of Pancreatic Enzyme Product (PEP) Microtabs in Pediatric Patients With Cystic Fibrosis and Exocrine Pancreatic Insufficiency | Cystic Fibrosis;Exocrine Pancreatic Insufficiency | Drug: EUR-1008 (APT-1008) | Forest Laboratories | NULL | Completed | N/A | 7 Years | All | 19 | Phase 3 | United States |
| 111 | NCT00297167 (ClinicalTrials.gov) | May 2006 | 27/2/2006 | Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency | A Randomized, Double-Blind, Placebo-Controlled, Two-Treatment, Crossover Study to Evaluate the Safety and Efficacy of Eurand Pancreatic Enzyme Product (PEP) in Patients With Cystic Fibrosis and Exocrine Pancreatic Insufficiency | Cystic Fibrosis;Exocrine Pancreatic Insufficiency | Drug: EUR-1008 (APT-1008);Drug: Placebo | Forest Laboratories | NULL | Completed | 7 Years | N/A | All | 34 | Phase 3 | United States |
| 112 | NCT00322868 (ClinicalTrials.gov) | April 2006 | 4/5/2006 | Safety and Efficacy of Pioglitazone as an Anti-inflammatory for the Treatment of Cystic Fibrosis (CF) Lung Disease | A Pilot Study Assessing the Safety and Efficacy of Pioglitazone as an Anti-inflammatory Agent for the Treatment of CF Lung Disease in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: pioglitazone | University Hospitals Cleveland Medical Center | Cystic Fibrosis Foundation | Completed | 18 Years | N/A | All | 21 | N/A | United States |
| 113 | NCT00420836 (ClinicalTrials.gov) | April 2006 | 10/1/2007 | Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study | Crossover Pharmacokinetic Study of Tobramycin Administered for Inhalation by PARI eFlow® Rapid Electronic Nebulizer (no Compressor) vs. PARI LC PLUSTM Jet Nebulizer (With Compressor) in Cystic Fibrosis Subjects | Cystic Fibrosis | Drug: Tobramycin | Novartis | NULL | Completed | 6 Years | N/A | Both | 20 | Phase 1 | NULL |
| 114 | EUCTR2005-003837-42-GB (EUCTR) | 26/09/2005 | 24/08/2005 | CIPROFLOXACIN-INDUCED PHOTOTOXICITY IN PATIENTS WITH CYSTIC FIBROSIS - ciprofloxacin phototoxicity cystic fibrosis | CIPROFLOXACIN-INDUCED PHOTOTOXICITY IN PATIENTS WITH CYSTIC FIBROSIS - ciprofloxacin phototoxicity cystic fibrosis | infection - ciprofloxacin is used to treat various infections, for example respiratory tract infections, ear, nose and throat infections, eye infections, urinary tract infections. The main indication that is relevant to this application is its use in the treatment of chest infections in patients with cystic fibrosis. I have included the ICD classification for chest infection below. | Trade Name: Ciprofloxacin (ciproxin) Product Name: N/A Product Code: N/A | Belfast City Hospital Trust | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 115 | NCT00219882 (ClinicalTrials.gov) | April 2005 | 16/9/2005 | Safety Study of Orally Administered Curcuminoids in Adult Subjects With Cystic Fibrosis | A Phase I Safety and Dose Finding Study of Orally Administered Curcuminoids in Adult Subjects With Cystic Fibrosis Who Are Homozygous for Delta F508 Cystic Fibrosis Transmembrane Conductance Regulator (?F508 CFTR) Mutation | Cystic Fibrosis | Drug: standardized turmeric root extract | Ramsey, Bonnie, MD | Seer Pharmaceuticals;CF Therapeutics Development Network Coordinating Center;Cystic Fibrosis Foundation Therapeutics | Completed | 18 Years | 40 Years | Both | 11 | Phase 1 | United States |
| 116 | NCT00198289 (ClinicalTrials.gov) | April 2005 | 9/9/2005 | Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs | A Phase IIa Dose Escalation Study to Assess Safety and Pharmacokinetics of Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs | Staphylococcus Aureus | Drug: Aurexis® (tefibazumab) | Bristol-Myers Squibb | NULL | Completed | 7 Years | N/A | Both | 30 | Phase 2 | United States |
| 117 | NCT00730509 (ClinicalTrials.gov) | April 2004 | 4/8/2008 | Effects of 5-Methyltetrahydrofolate and Vitamin B12 Supplemetation on Red Cell Membrane in Children With Cystic Fibrosis | Preliminary Evidences of Active Form of Folic Acid and Vitamin B12 Supplementation to Ameliorate Cell Membrane in Children With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: 5-methyltetrahydrofolate and vitamin B12 | Universita di Verona | NULL | Completed | 3 Years | 8 Years | Both | 31 | N/A | Italy |
| 118 | NCT00499720 (ClinicalTrials.gov) | October 2003 | 9/7/2007 | Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection | Expanded Access Program for Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease Progression | Cystic Fibrosis;Pseudomonas Aeruginosa Airway Infection | Drug: Aztreonam Lysine for Inhalation | Gilead Sciences | NULL | Approved for marketing | 6 Years | N/A | Both | N/A | United States;Puerto Rico | |
| 119 | NCT00222521 (ClinicalTrials.gov) | April 2003 | 14/9/2005 | Insulin Glargine Vs Standard Insulin Therapy | Comparison of Insulin Glargine Vs Standard Insulin Therapy in CFRD Without Fasting Hyperglycemia | Cystic Fibrosis Related Diabetes | Drug: Glargine insulin | University of Minnesota - Clinical and Translational Science Institute | Sanofi;Moran, Antoinette, M.D. | Completed | 12 Years | N/A | Both | 20 | Phase 3 | United States |
| 120 | NCT00056147 (ClinicalTrials.gov) | April 2003 | 6/3/2003 | Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease | Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of INS37217 Inhalation Solution in Subjects With Mild to Moderate Cystic Fibrosis Lung Disease | Cystic Fibrosis | Drug: denufosol tetrasodium (INS37217) | Merck Sharp & Dohme Corp. | Cystic Fibrosis Foundation Therapeutics | Completed | 8 Years | 50 Years | Both | 90 | Phase 2 | United States |
| 121 | NCT00376428 (ClinicalTrials.gov) | January 2003 | 13/9/2006 | Interest of Gentamicin-induced Readthrough in Cystic Fibrosis Patients | Application of Functional Electrophysiological Tests to Evaluate Pharmacological Treatments in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Gentamicin | Assistance Publique - Hôpitaux de Paris | NULL | Terminated | N/A | N/A | Both | 20 | Phase 2 | France |
| 122 | NCT00043342 (ClinicalTrials.gov) | April 2002 | 7/8/2002 | Study of Interferon Gamma-1b by Injection for the Treatment of Patients With Cystic Fibrosis | A Phase I/II Study of Interferon Gamma-1b by Subcutaneous Injection for the Treatment of Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: interferon gamma-1b | InterMune | NULL | Completed | 6 Years | N/A | Both | 51 | Phase 1/Phase 2 | United States |
| 123 | NCT02269189 (ClinicalTrials.gov) | April 2002 | 16/10/2014 | Safety, Tolerability and Pharmacokinetics of BIIL 284 BS in Adult and Pediatric Cystic Fibrosis (CF) Patients | A Randomized, Double-blind Within Dose, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Repeated Oral Doses (15-day Dosing) of BIIL 284 BS in Adult (300 mg) and Pediatric (150 mg) Cystic Fibrosis Patients | Cystic Fibrosis | Drug: BIIL 284 BS, high dose;Drug: BIIL 284 BS, low dose;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 6 Years | N/A | Both | 36 | Phase 1 | NULL |
| 124 | NCT00005112 (ClinicalTrials.gov) | April 2000 | 15/4/2000 | Growth Hormone Use in Cystic Fibrosis - a Multicenter Study | Cystic Fibrosis | Drug: Human recombinant growth hormone | National Center for Research Resources (NCRR) | Genentech, Inc. | Completed | 5 Years | 12 Years | Both | Phase 3 | United States | ||
| 125 | NCT00005110 (ClinicalTrials.gov) | April 2000 | 13/4/2000 | A Multi-Centered Study of the Long-Term Effect of Salmeterol and Albuterol in Cystic Fibrosis | Cystic Fibrosis | Drug: Salmeterol;Drug: Albuterol | National Center for Research Resources (NCRR) | NULL | Suspended | 5 Years | 45 Years | Both | N/A | United States | ||
| 126 | EUCTR2017-001379-21-IE (EUCTR) | 26/07/2017 | A study to assess the safety and pharmacodynamics of long-term ivacaftor treatment in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs). | A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 3 | Canada;United States;Ireland;United Kingdom;Germany | |||
| 127 | EUCTR2016-001840-20-Outside-EU/EEA (EUCTR) | 18/05/2016 | Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis Patients | A Multi-center, Human Factors Engineering (HFE) Usability Study in Cystic Fibrosis Patients to Validate the Approved Instructions for Use (IFU) of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using Placebo Capsules. | cystic fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler | Novartis Pharmaceuticals Corporation | NULL | NA | Female: yes Male: yes | 45 | Phase 4 | United States | |||
| 128 | EUCTR2018-002624-16-FR (EUCTR) | 21/11/2018 | NA | Validation of respiratory epithelial functional assessment to predict clinical efficacy of Orkambi®. Pathway to personalized therapy in Cystic Fibrosis PREDICT-CF - PREDICT-CF | Homozygous F508del patient aged 12 years or older MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Orkambi® Product Name: Orkambi® | ASSISTANC-PUBLIQUE-HOPITAUX DE PARIS (AP-HP) | NULL | NA | Female: yes Male: yes | 104 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France | |||
| 129 | EUCTR2017-001379-21-DE (EUCTR) | 01/08/2017 | A study to assess the safety and pharmacodynamics of long-term ivacaftor treatment in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs). | A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 3 | Canada;United States;Ireland;United Kingdom;Germany | |||
| 130 | EUCTR2008-002673-13-DE (EUCTR) | 27/08/2008 | Anti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo | Anti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo | Deficiency of the Cftr-molecule results in accumulation of ceramide in respiratory epithelial cells. Ceramide triggers a pro-inflammatory and -apoptotic status in cystic fibrosis patients. Amitriptyline reduces ceramide levels in the lung tissue, normalises the activity of cytokines and prevents constitutive cell death of epithelial cells. Amitriptyline prevents pulmonary infections of CF-mice with P. aeruginosa. Amitriptyline may result in an improved lung function of cystic fibrosis patients. | Trade Name: Amitriptylin-CT Product Name: Amitriptyline INN or Proposed INN: Amitriptyline | PSKS | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Germany |