2. 筋萎縮性側索硬化症
［臨床試験数：508，薬物数：530（DrugBank：146），標的遺伝子数：170，標的パスウェイ数：221］
Searched query = "Amyotrophic lateral sclerosis", "ALS"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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 | 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 |
| 2 | 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 | United States;Portugal;Slovenia;Spain;Ireland;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 3 | 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 | Recruiting | 18 Years | N/A | All | 228 | Phase 2 | United States |
| 4 | 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;Germany;Netherlands;Sweden | ||
| 5 | 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 | Enrolling by invitation | 18 Years | N/A | All | 90 | Phase 1 | United States;Canada;Netherlands;Switzerland;United Kingdom |
| 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 |
| 6 | 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: Trametinib (2 mg);Drug: Riluzole (100 mg) | Genuv Inc. | NULL | Recruiting | 19 Years | 75 Years | All | 30 | Phase 1;Phase 2 | Korea, Republic of |
| 7 | 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 | ||
| 8 | 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 |
| 9 | 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 |
| 10 | 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 |
| 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 |
| 11 | 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 |
| 12 | 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 | Recruiting | 18 Years | 80 Years | All | 54 | Phase 2 | Italy |
| 13 | 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 | Recruiting | 18 Years | N/A | All | 200 | Phase 1 | United States |
| 14 | 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. | Recruiting | 20years-old | 80years-old | Male and Female | 24 | Phase 1 | Japan |
| 15 | 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 |
| 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 |
| 16 | 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 | Recruiting | 18 Years | 70 Years | All | 21 | Phase 1;Phase 2 | Israel |
| 17 | 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 |
| 18 | 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 |
| 19 | 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. | 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 | |
| 20 | 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 | Japan | |
| 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 |
| 21 | 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 continuing | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 22 | 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 |
| 23 | 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 | Active, not recruiting | 40 Years | 78 Years | All | 60 | Phase 2 | Japan |
| 24 | 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 |
| 25 | 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 |
| 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 |
| 26 | JPRN-UMIN000026221 | 2017/03/02 | 01/03/2017 | 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 | |
| 27 | 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 |
| 28 | 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 |
| 29 | NCT02710110 (ClinicalTrials.gov) | April 2016 | 26/2/2016 | Respiratory Strength Training in Persons With Amyotrophic Lateral Sclerosis (ALS) | The Impact of Respiratory Strength Training in Individuals With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Device: PowerLung trainer;Device: Micro Mouth Pressure Meter;Procedure: Pulmonary Function Testing;Procedure: Videofluoroscopic swallowing study;Other: Swallowing Quality of Life Questionnaire;Device: Iowa Oral Pressure Instrument;Drug: Capsaicin | University of Florida | ALS Association | Completed | 21 Years | 85 Years | All | 50 | Early Phase 1 | United States |
| 30 | 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 |
| 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 |
| 31 | NCT02710162 (ClinicalTrials.gov) | April 2016 | 29/2/2016 | Accurate Screening Tools for Dysphagia in Amyotrophic Lateral Sclerosis (ALS) | Determination of Accurate Screening Tools for Dysphagia in Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Device: Micro Mouth Pressure Meter;Device: Iowa Oral Performance Instrument;Device: Electrical Impedance Myography;Drug: Capsaicin;Procedure: Videofluoroscopic Swallowing Study;Procedure: Pulmonary Function Testing;Other: Swallowing Related Quality of Life Questionnaire;Other: Functional Oral Intake Scale;Other: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised;Other: Eating Assessment Tool-10;Other: Communicative Effectiveness Survey;Other: The Center for Neurologic Studies Bulbar Function Scale | University of Florida | NULL | Completed | 21 Years | 85 Years | All | 21 | Early Phase 1 | United States |
| 32 | NCT02881476 (ClinicalTrials.gov) | November 2015 | 22/4/2016 | Therapeutic Treatment of Amyotrophic Lateral Sclerosis | Application of Wharton's Jelly-derived Mesenchymal Stem Cells in the Treatment of Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Other: Biological: Cell-based therapy | University of Warmia and Mazury | NULL | Enrolling by invitation | 18 Years | 65 Years | Both | 30 | Phase 1 | NULL |
| 33 | 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. | 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 | |
| 34 | 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 | ||
| 35 | 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 |
| 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 |
| 36 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2;Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ireland;Israel;Colombia;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Netherlands;Germany | ||
| 37 | 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] | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 381 | Phase 2;Phase 3 | Serbia;Portugal;United States;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany | |||
| 38 | 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 |
| 39 | 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 | ||
| 40 | JPRN-UMIN000016352 | 2015/02/01 | 01/02/2015 | The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis: Single centered open label trial | amyotrophic lateral sclerosis | edaravone | Ehime University Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 10 | Phase 1;Phase 2 | Japan | |
| 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 |
| 41 | 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 | |||
| 42 | 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] | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 381 | Phase 2;Phase 3 | Portugal;Serbia;United States;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany | |||
| 43 | 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 |
| 44 | 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 | 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 | |
| 45 | 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 |
| 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 |
| 46 | 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 |
| 47 | 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 |
| 48 | 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 | ||
| 49 | JPRN-UMIN000006423 | 2011/10/01 | 01/10/2011 | The clinical trial to assess efficacy of mexiletine for 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 | |
| 50 | 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 |
| 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 |
| 51 | 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 |
| 52 | 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 | ||||
| 53 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 470 | Phase 2;Phase 3 | United Kingdom;Germany;Belgium;France;Spain | ||
| 54 | JPRN-UMIN000002276 | 2009/08/01 | 01/08/2009 | Developmental research of communication devices based on the brain machine interface using electroencephalograms | 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 | |
| 55 | 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;Phase 3 | United Kingdom;Germany;Belgium;France;Spain | ||
| 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 |
| 56 | 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 | ||
| 57 | 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 |
| 58 | 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 |
| 59 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 470 | Phase 2;Phase 3 | United Kingdom;Germany;Belgium;France;Spain | ||
| 60 | 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 | ||
| 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 |
| 61 | 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 | ||||
| 62 | 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 | ||||
| 63 | 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 | ||||
| 64 | 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 |
| 65 | 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 |
| 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 |
| 66 | 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 |
| 67 | 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 |
| 68 | 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 |