6. パーキンソン病 Parkinson disease Clinical trials / Disease details
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 | EUCTR2020-002754-24-DE (EUCTR) | 19/01/2022 | 14/06/2021 | Clinical study in early PD patients to investigate the effect of Opicapone 50mg or Levodopa 100 mg in the treatment of motor fluctuations. | A randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study to evaluate the add-on effect of opicapone 50 mg or levodopa 100 mg as first strategy for the treatment of wearing-off in patients with Parkinson’s Disease. - ADOPTION: eArly levoDopa with Opicapone in Parkinson’s paTients wIth motOr fluctuatioNs | Parkinson's Disease (PD) 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: Ongentys 50 mg hard capsules INN or Proposed INN: Ongentys 50 mg hard capsules Other descriptive name: OPICAPONE Trade Name: Madopar 125 mg T, tablets INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Trade Name: SINEMET 100 mg + 25 mg tablets INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 2 | NCT05094050 (ClinicalTrials.gov) | January 18, 2022 | 20/10/2021 | Study to Assess How ABBV-951 is Absorbed When Administered at Different Subcutaneous Sites of Adult Participants With Parkinson's Disease | Parkinson's Disease: A Comparative Study of Levodopa and Carbidopa Bioavailability Following Foslevodopa/Foscarbidopa Infusion at Different Subcutaneous Sites in Parkinson's Disease Patients | Parkinson's Disease | Drug: ABBV-951 | AbbVie | NULL | Active, not recruiting | 30 Years | N/A | All | 16 | Phase 1 | United States |
| 3 | NCT05083260 (ClinicalTrials.gov) | January 4, 2022 | 23/9/2021 | NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa | A Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetics Study in Parkinson's Disease (PD) Participants Treated With Carbidopa/Levodopa and NE3107 | Parkinson Disease | Drug: NE3107;Drug: placebo | BioVie Inc. | NULL | Completed | 30 Years | 80 Years | All | 46 | Phase 1/Phase 2 | United States |
| 4 | NCT04952194 (ClinicalTrials.gov) | January 1, 2022 | 3/6/2021 | Clinical Study of Stalevo in the Treatment of Early Parkinson's Disease | Clinical Study of Stalevo in the Treatment of Early Parkinson's Disease | Parkinson Disease | Drug: Stalevo;Drug: Carbidopa and Levodopa Controlled Release Tablets | Second Affiliated Hospital, School of Medicine, Zhejiang University | NULL | Recruiting | 30 Years | 70 Years | All | 180 | Phase 4 | China |
| 5 | EUCTR2019-004235-23-SE (EUCTR) | 13/11/2021 | 24/08/2021 | Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease. | An open-label extension of Study M15-741 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 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: Foscarbidopa and Foslevodopa Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | Abbvie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Denmark;Australia;Russian Federation;Germany;Netherlands;Italy;United Kingdom;Japan;Sweden | ||
| 6 | NCT05128175 (ClinicalTrials.gov) | October 29, 2021 | 27/10/2021 | Comparative Bioavailability Study of Carbidopa/Levodopa Extended-Release Tablets Under Fasting and Fed Conditions | An Open-label, Balanced, Randomized, Five-treatment, Five-period, Five-sequence, Multiple Oral Dose, Crossover Comparative Bioavailability Study of Different Strengths of Carbidopa/Levodopa Extended-release Tablets With Carbidopa and Levodopa Tablets in Normal, Healthy Adult Human Subjects Under Fasting and Fed Conditions | Parkinson Disease | Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets | Shanghai WD Pharmaceutical Co., Ltd. | NULL | Recruiting | 18 Years | 45 Years | All | 15 | Phase 1 | India |
| 7 | NCT05036473 (ClinicalTrials.gov) | October 12, 2021 | 10/8/2021 | A Study of the Efficacy and Safety of Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's Disease | A Phase II Randomized, Parallel, Double-blind, Placebo-controlled, Multi-center Clinical Trial of the Efficacy and Safety of WD-1603 Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's Disease | Parkinson Disease | Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets;Drug: Placebo | Shanghai WD Pharmaceutical Co., Ltd. | NULL | Recruiting | 30 Years | 75 Years | All | 40 | Phase 2 | China |
| 8 | EUCTR2020-002754-24-IT (EUCTR) | 09/09/2021 | 30/08/2021 | Clinical study in early PD patients to investigate the effect of Opicapone 50mg or Levodopa 100 mg in the treatment of motor fluctuations. | A randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study to evaluate the add-on effect of opicapone 50 mg or levodopa 100 mg as first strategy for the treatment of wearing-off in patients with Parkinson's Disease. - ADOPTION: eArly levoDopa with Opicapone in Parkinson's paTients wIth motOr fluctuatioNs | Parkinson's Disease (PD) 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 100 mg + 25 mg tablets Product Name: SINEMET 100 mg + 25 mg compresse Product Code: [023145028] INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: Carbidopa Trade Name: Madopar 125 mg T, tablets Product Name: Madopar® 125 mg T Tablets Levodopa 100 mg Benserazide 25 mg (as benserazide hydrochloride) Product Code: [6036937.00.01] INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE INN or Proposed INN: Levodopa Other descriptive name: Levodopa Trade Name: Ongentys 50 mg hard capsules Product Name: Ongentys 50 mg capsule rigide Product Code: [BIA 9-1067] INN or Proposed INN: Opicapone Other descriptive name: Opicapone | BIAL-Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 9 | EUCTR2020-003372-41-ES (EUCTR) | 27/07/2021 | 09/06/2021 | Investigating the DopaFuse® Delivery System in Parkinson’s Disease Patients. Assessing safety, effectiveness, how well it is tolerated, and how the drug is processed by the body. | Assessing the Pharmacokinetics, Safety, Tolerability and Efficacy of Continuous Oral Levodopa via the DopaFuse Delivery System in Parkinson’s Disease Patients - Study of Continuous Oral Levodopa: SCOL | Motor symptoms in 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: DopaFuse Delivery System INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | SynAgile Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 1;Phase 2 | Spain;Luxembourg;Italy | ||
| 10 | EUCTR2020-002754-24-ES (EUCTR) | 06/07/2021 | 09/06/2021 | Clinical study in early PD patients to investigate the effect of Opicapone 50mg or Levodopa 100 mg in the treatment of motor fluctuations. | A randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study to evaluate the add-on effect of opicapone 50 mg or levodopa 100 mg as first strategy for the treatment of wearing-off in patients with Parkinson’s Disease. - ADOPTION: eArly levoDopa with Opicapone in Parkinson’s paTients wIth motOr fluctuatioNs | Parkinson's Disease (PD) 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: Ongentys 50 mg hard capsules INN or Proposed INN: Ongentys 50 mg hard capsules Other descriptive name: OPICAPONE Trade Name: Madopar 125 mg T, tablets INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA Trade Name: SINEMET 100 mg + 25 mg tablets INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 11 | EUCTR2021-000541-41-DE (EUCTR) | 09/06/2021 | 29/04/2021 | Joint European Research on active and emerging pandemics | European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial - EU-SolidAct | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa | Oslo University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Phase 3 | United States;Czechia;Estonia;Spain;Ukraine;Lithuania;Italy;United Kingdom;France;Czech Republic;Poland;Romania;Germany;Latvia | ||
| 12 | EUCTR2019-004235-23-DE (EUCTR) | 19/05/2021 | 25/02/2021 | Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease. | An open-label extension of Study M15-741 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 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: Foscarbidopa and Foslevodopa Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | Abbvie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Denmark;Australia;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Japan;Sweden | ||
| 13 | EUCTR2020-003372-41-IT (EUCTR) | 27/01/2021 | 15/06/2021 | Investigating the DopaFuse® Delivery System in Parkinson's Disease Patients. Assessing safety, effectiveness, how well it is tolerated, and how the drug is processed by the body. | Assessing the Pharmacokinetics, Safety, Tolerability and Efficacy of Continuous Oral Levodopa via the DopaFuse® Delivery System in Parkinson’s Disease Patients - Study of Continuous Oral Levodopa: SCOL | Motor symptoms in 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: DopaFuse Delivery System Product Code: [N04BA] INN or Proposed INN: LEVODOPA Other descriptive name: Levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: Carbidopa | SynAgile Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | Spain;Luxembourg;Italy | ||
| 14 | NCT04590612 (ClinicalTrials.gov) | January 2021 | 17/9/2020 | Improving Quality of Life in Early Parkinson's Disease | The Effects of Mood Symptoms Treatment on Quality of Life and Motor Function in de Novo Parkinson's Disease Patients | Parkinson Disease;Depression | Drug: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet;Drug: Citalopram | Western University, Canada | NULL | Not yet recruiting | 50 Years | 80 Years | All | 30 | N/A | NULL |
| 15 | EUCTR2019-004235-23-DK (EUCTR) | 18/11/2020 | 22/06/2020 | Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease. | An open-label extension of Study M15-741 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 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: Foscarbidopa and Foslevodopa Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | Abbvie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Australia;Denmark;Russian Federation;Germany;Netherlands;Italy;United Kingdom;Japan;Sweden | ||
| 16 | EUCTR2019-004235-23-NL (EUCTR) | 09/11/2020 | 26/05/2020 | Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease. | An open-label extension of Study M15-741 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 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: Foscarbidopa and Foslevodopa Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | Abbvie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Denmark;Australia;Russian Federation;Germany;Netherlands;Italy;United Kingdom;Japan;Sweden | ||
| 17 | NCT04380142 (ClinicalTrials.gov) | October 19, 2020 | 6/5/2020 | Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease | A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients | Parkinson's Disease (PD) | Drug: ABBV-951;Drug: Placebo for Levodopa/Carbidopa (LD/CD);Drug: Levodopa/Carbidopa (LD/CD);Drug: Placebo for ABBV-951 | AbbVie | NULL | Completed | 30 Years | N/A | All | 174 | Phase 3 | United States;Australia |
| 18 | NCT04591535 (ClinicalTrials.gov) | September 28, 2020 | 11/9/2020 | PK Study of WD-1603 in Healthy Subjects | An Open Label, Balanced, Randomised, Four-treatment, Four-period, Four-sequence, Single Oral Dose, Crossover PK Study of WD-1603 in Normal, Healthy, Adult Human Subjects Under Fed Conditions | Parkinson Disease | Drug: WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS | Hong Kong WD Pharmaceutical Co., Limited | NULL | Recruiting | 18 Years | 45 Years | All | 8 | Phase 1 | India |
| 19 | EUCTR2019-004235-23-GB (EUCTR) | 15/09/2020 | 28/05/2020 | Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease. | An open-label extension of Study M15-741 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 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: Foscarbidopa and Foslevodopa Product Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | Abbvie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Australia;Russian Federation;Japan;United Kingdom | ||
| 20 | NCT04513340 (ClinicalTrials.gov) | August 13, 2020 | 12/8/2020 | WD-1603 PK Study Under Fasting and Fed Conditions in Healthy Subjects | AN OPEN LABEL, BALANCED, RANDOMISED, FOUR-TREATMENT, FOUR-PERIOD, FOUR-SEQUENCE, SINGLE INTRA-ORAL AND ORAL DOSE, CROSSOVER PHARMACOKINETICS STUDY OF WD-1603 EXTENDED-RELEASE CARBIDOPA/LEVODOPA TABLETS 25/100MG IN NORMAL, HEALTHY, ADULT HUMAN SUBJECTS UNDER FASTING AND FED CONDITIONS | Parkinson Disease | Drug: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS | Hong Kong WD Pharmaceutical Co., Limited | NULL | Recruiting | 18 Years | 45 Years | All | 8 | Phase 1 | India |
| 21 | 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 |
| 22 | EUCTR2018-004156-37-PT (EUCTR) | 16/06/2020 | 09/12/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | 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: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD/CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | Portugal;Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Netherlands;Sweden;Korea, Republic of | ||
| 23 | EUCTR2018-004156-37-NL (EUCTR) | 14/06/2020 | 13/01/2020 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | 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: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | Serbia;United States;Portugal;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden | ||
| 24 | EUCTR2018-004156-37-SE (EUCTR) | 18/05/2020 | 10/09/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | 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: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Netherlands;Sweden;Korea, Republic of | ||
| 25 | EUCTR2018-002144-85-DE (EUCTR) | 07/05/2020 | 06/06/2019 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | 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 - Galliarde | 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 Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Canada;Belgium;Spain;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom;Japan | ||
| 26 | EUCTR2018-004156-37-IT (EUCTR) | 04/05/2020 | 17/06/2021 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson's disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson's disease experiencing motor fluctuations (BouNDless) - BouNDless | 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: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP Product Code: [NA] INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: [ND0612] INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA | NEURODERM LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | Portugal;Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden;Korea, Republic of | ||
| 27 | EUCTR2018-004156-37-SK (EUCTR) | 30/04/2020 | 13/02/2020 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | 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: Levodopa/Carbidopa Solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | United States;Portugal;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden | ||
| 28 | EUCTR2018-004156-37-BE (EUCTR) | 27/04/2020 | 03/03/2020 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | 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: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | Serbia;United States;Portugal;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden | ||
| 29 | EUCTR2018-002233-37-PL (EUCTR) | 23/04/2020 | 24/01/2020 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations. | A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czech Republic;Canada;Spain;Poland;Germany;United Kingdom;Italy | ||
| 30 | EUCTR2020-000686-16-NL (EUCTR) | 26/03/2020 | 09/03/2020 | Validation of finger tapping in PD patients | Randomized, double-blind, placebo-controlled crossover study to validate finger tapping tasks for the quantification of levodopa/carbidopa effects in Parkinson’s Disease patients. | 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: SINEMET 125 Product Name: SINEMET Product Code: RVG 08740 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopamonohydraat Other descriptive name: CARBIDOPA MONOHYDRATE | Centre for Human Drug Research | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Netherlands | ||
| 31 | EUCTR2018-004156-37-AT (EUCTR) | 02/03/2020 | 05/11/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | 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: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | United States;Portugal;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden | ||
| 32 | NCT04821830 (ClinicalTrials.gov) | February 12, 2020 | 10/3/2021 | Vigor and the LDR in Parkinson Disease | Vigor and the LDR in Parkinson Disease | Parkinson Disease | Drug: carbidopa/levodopa, as prescribed by treating physician | University of Michigan | National Institute of Neurological Disorders and Stroke (NINDS) | Recruiting | 45 Years | 90 Years | All | 40 | United States | |
| 33 | EUCTR2018-004156-37-ES (EUCTR) | 11/02/2020 | 06/11/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | 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: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | Russian Federation;Hungary;United States;Ukraine;United Kingdom;Portugal;Spain;Canada;Austria;Czech Republic;Netherlands;Sweden;Belgium;Korea, Republic of;Poland;Italy;Israel;Slovakia;France;Serbia | ||
| 34 | EUCTR2018-002234-21-GB (EUCTR) | 05/02/2020 | 04/07/2019 | An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease 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's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;United States;Czech Republic;Spain;Germany;Italy;United Kingdom | ||
| 35 | NCT04246437 (ClinicalTrials.gov) | February 4, 2020 | 25/1/2020 | [18F]F-DOPA Imaging in Patients With Autonomic Failure | [18F]F-DOPA Imaging in Patients With Autonomic Failure | Autonomic Failure;Pure Autonomic Failure;Parkinson Disease;Multiple System Atrophy;Dementia With Lewy Bodies | Drug: [18F]FDOPA;Drug: Carbidopa 200mg oral dose;Drug: Entacapone 400mg oral dose | Daniel Claassen | NULL | Recruiting | 18 Years | N/A | All | 40 | Phase 1 | United States |
| 36 | EUCTR2018-004156-37-GB (EUCTR) | 14/01/2020 | 13/09/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | 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: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | Russian Federation;Hungary;United States;Ukraine;United Kingdom;Portugal;Spain;Canada;Austria;Czech Republic;Netherlands;Sweden;Belgium;Korea, Republic of;Poland;Italy;Israel;Slovakia;France;Serbia | ||
| 37 | EUCTR2018-004156-37-HU (EUCTR) | 19/12/2019 | 18/10/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | 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: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Netherlands;Sweden;Korea, Republic of | ||
| 38 | EUCTR2018-004156-37-CZ (EUCTR) | 26/11/2019 | 26/09/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | 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: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | Portugal;Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden | ||
| 39 | EUCTR2018-002233-37-GB (EUCTR) | 11/10/2019 | 14/02/2019 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations. | A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom | ||
| 40 | EUCTR2018-002234-21-DE (EUCTR) | 23/09/2019 | 16/05/2019 | An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease 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's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa | Impax Laboratories, LLC | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Estonia;Spain;Ukraine;Lithuania;Italy;United Kingdom;France;Czech Republic;Poland;Romania;Germany;Latvia | ||
| 41 | EUCTR2018-002144-85-NL (EUCTR) | 11/09/2019 | 27/03/2019 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | 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 - Galliarde | 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 Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;United Kingdom;Japan | ||
| 42 | NCT04006210 (ClinicalTrials.gov) | August 27, 2019 | 30/6/2019 | Efficacy, Safety and Tolerability Study of ND0612 vs. Oral IR-LD/CD in Subjects With PD Experiencing Motor Fluctuations | A Multicenter, Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Study of the Efficacy, Safety, and Tolerability of Continuous SC ND0612 Infusion vs. Oral IR-LD/CD in Subjects With PD Experiencing Motor Fluctuations | Parkinson's Disease | Combination Product: ND0612 Solution for SC infusion;Combination Product: Placebo for SC infusion;Drug: Carbidopa and Levodopa 25mg/100mg;Drug: Placebo for Carbidopa and Levodopa 25mg/100mg | NeuroDerm Ltd. | NULL | Active, not recruiting | 30 Years | 80 Years | All | 381 | Phase 3 | United States;Austria;Belgium;Czechia;France;Hungary;Israel;Italy;Netherlands;Poland;Portugal;Russian Federation;Serbia;Slovakia;Spain;Ukraine;United Kingdom |
| 43 | EUCTR2018-002234-21-ES (EUCTR) | 21/08/2019 | 11/06/2019 | An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease 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's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia | ||
| 44 | EUCTR2018-002144-85-BE (EUCTR) | 20/08/2019 | 24/04/2019 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | 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 - Galliarde | 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 Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Canada;Spain;Belgium;Denmark;Australia;Germany;Netherlands;United Kingdom;Japan | ||
| 45 | EUCTR2018-002144-85-GB (EUCTR) | 29/07/2019 | 13/03/2019 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | 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 - Galliarde | 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 Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;Japan;United Kingdom | ||
| 46 | EUCTR2018-002144-85-ES (EUCTR) | 11/07/2019 | 12/04/2019 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | 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 - Galliarde | 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 Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | AbbVie Deutschland | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;Italy;United Kingdom;Japan | ||
| 47 | EUCTR2018-002144-85-DK (EUCTR) | 08/07/2019 | 14/03/2019 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | 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 - Galliarde | 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 Code: ABBV-951 INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | AbbVie Deutschland | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Canada;Belgium;Spain;Australia;Denmark;Germany;Netherlands;Italy;United Kingdom;Japan | ||
| 48 | EUCTR2018-002144-85-IT (EUCTR) | 21/06/2019 | 15/06/2021 | Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion study | 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 - Galliarde | Parkinson's Disease MedDRA version: 21.1;Level: PT;Classification code 10068100;Term: Vascular parkinsonism;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ABBV-951 Product Code: [ABBV-951] INN or Proposed INN: Foslevodopa Other descriptive name: Levodopa-4'-Monophosphate INN or Proposed INN: Foscarbidopa Other descriptive name: Carbidopa-4'-Monophosphate | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;United Kingdom;Japan;Italy | ||
| 49 | EUCTR2018-002234-21-CZ (EUCTR) | 14/06/2019 | 30/05/2019 | An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease 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's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Czechia;Estonia;Spain;Ukraine;Lithuania;Italy;United Kingdom;France;Czech Republic;Poland;Romania;Germany;Latvia | ||
| 50 | EUCTR2018-002233-37-IT (EUCTR) | 03/05/2019 | 07/01/2021 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson's with motor fluctuations. | A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. - NA | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: [IPX203] INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: [IR CD-LD] INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 510 | Phase 3 | France;United States;Czechia;Poland;Spain;Germany;United Kingdom;Italy | ||
| 51 | EUCTR2018-002233-37-DE (EUCTR) | 17/04/2019 | 08/01/2019 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations. | A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czechia;Poland;Spain;Germany;United Kingdom;Italy | ||
| 52 | EUCTR2018-002233-37-CZ (EUCTR) | 18/03/2019 | 11/12/2018 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations. | A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czech Republic;Poland;Spain;Germany;United Kingdom;Italy | ||
| 53 | NCT03887884 (ClinicalTrials.gov) | March 5, 2019 | 1/3/2019 | Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) | Randomized, Multi-center, Open-label, Crossover Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) and an Oral Dose of Carbidopa/Levodopa CD/LD Under Fed Conditions in Patients With Parkinson's Disease | Parkinson's Disease | Drug: CVT-301;Drug: Sinemet | Acorda Therapeutics | NULL | Completed | 30 Years | 85 Years | All | 23 | Phase 1 | United States |
| 54 | NCT03670953 (ClinicalTrials.gov) | November 6, 2018 | 12/9/2018 | A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Patients With Motor Fluctuations | A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease (Disorder) | Drug: IR CD-LD;Drug: IPX203 ER CD-LD;Other: IPX203 placebo;Other: IR CD-LD placebo | Impax Laboratories, LLC | NULL | Completed | 40 Years | N/A | All | 631 | Phase 3 | United States;Czechia;France;Germany;Italy;Poland;Spain;United Kingdom |
| 55 | EUCTR2016-002033-30-NL (EUCTR) | 31/10/2018 | 15/11/2017 | A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations 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: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany | ||
| 56 | EUCTR2018-001209-95-IT (EUCTR) | 05/07/2018 | 03/08/2021 | An open-label Phase 2 study to assess the pharmacokinetics of Accordion Pill¿ Carbidopa-Levodopa compared to immediate release carbidopa-levodopa in patients with Parkinson¿s disease | An open-label Phase 2 study to assess the pharmacokinetics of Accordion Pill¿ Carbidopa-Levodopa compared to immediate release carbidopa-levodopa in patients with Parkinson¿s disease - IN 18001 | 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: Accordion Pill¿ Carbidopa/levodopa Product Code: N.A. INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA Trade Name: SINEMET - 100 MG + 25 MG COMPRESSE 50 COMPRESSE DIVISIBILI Product Name: Sinemet Product Code: N.A. INN or Proposed INN: LEVODOPA Other descriptive name: Levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA | INTEC PHARMA LTD | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Spain;Italy | ||
| 57 | NCT03576638 (ClinicalTrials.gov) | July 2018 | 25/6/2018 | Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease Patients | An Open Label Phase 2 Study to Assess the Pharmacokinetics of the Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Patients With Parkinson's Disease | Parkinson Disease | Drug: Accordion Pill Carbidopa/Levodopa;Drug: Sinemet CR 25Mg-100Mg Extended-Release Tablet | Intec Pharma Ltd. | NULL | Unknown status | 30 Years | N/A | All | 12 | Phase 2 | NULL |
| 58 | EUCTR2017-002780-17-ES (EUCTR) | 21/05/2018 | 12/02/2018 | Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the blood levels of Levodopa Administered as ND0612 via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Duodopa. | A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension | 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: ND0612 Product Code: ND0612 INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | France;United States;Spain;Austria;Netherlands;Italy | ||
| 59 | EUCTR2017-002780-17-FR (EUCTR) | 26/04/2018 | 27/02/2018 | - | A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension | 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: ND0612 Product Code: ND0612 INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Spain;Austria;Netherlands;Italy | ||
| 60 | EUCTR2017-002780-17-IT (EUCTR) | 10/04/2018 | 04/11/2020 | study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered as subcutaneous infusion | A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson¿s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension - study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered | 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 Plus Product Name: SINEMET INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: LEVODOPA Other descriptive name: levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: carbidopa Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: CARBIDOPA Other descriptive name: carbidopa INN or Proposed INN: LEVODOPA Other descriptive name: levodopa | NEURODERM LTD. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | United States;France;Spain;Austria;Netherlands;Italy | ||
| 61 | EUCTR2016-002033-30-IT (EUCTR) | 10/04/2018 | 20/01/2021 | A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations 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: levodopa / carbidopa solution Product Code: ND0612 INN or Proposed INN: LEVODOPA Other descriptive name: levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: carbidopa Product Name: levodopa / carbidopa solution Product Code: ND0612 INN or Proposed INN: LEVODOPA Other descriptive name: Levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: Carbidopa | NEURODERM LTD. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | France;Hungary;Belgium;Spain;Netherlands;United Kingdom;Italy | ||
| 62 | NCT03496870 (ClinicalTrials.gov) | February 8, 2018 | 1/3/2018 | A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa. | A Phase 1, Open-Label Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Repeated Doses of Opicapone, and Effect on Levodopa Pharmacokinetics in Subjects With Parkinson's Disease | Parkinson Disease | Drug: Opicapone;Drug: Carbidopa Levodopa | Neurocrine Biosciences | NULL | Completed | 18 Years | 85 Years | All | 16 | Phase 1 | United States |
| 63 | EUCTR2016-001403-23-HU (EUCTR) | 23/01/2018 | 22/01/2018 | 12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease | An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study | Dyskinesia in advanced Parkinson's disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Hungary;Slovakia;European Union;Greece;Finland;Spain | ||
| 64 | EUCTR2016-002033-30-GB (EUCTR) | 27/11/2017 | 05/09/2017 | A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations 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: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany | ||
| 65 | EUCTR2016-002033-30-HU (EUCTR) | 08/11/2017 | 19/09/2017 | A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations 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: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Netherlands;Germany | ||
| 66 | EUCTR2014-004865-26-GR (EUCTR) | 01/08/2017 | 25/04/2017 | 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease | An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study | Non-motor symptoms in advanced Parkinson's disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 88 | Phase 3 | United States;European Union;Canada;Greece;Spain;Australia;Germany;Italy;Sweden | ||
| 67 | EUCTR2017-000262-30-IT (EUCTR) | 10/07/2017 | 04/11/2020 | Efficacy, Safety, Tolerability and Pharmacokinetics of EXN-32 and EXN-44 in patients with Parkinson¿s Disease experiencing motor fluctuations | Efficacy, Safety, Tolerability and Pharmacokinetics of EXN-32 and EXN-44 in patients with Parkinson¿s Disease experiencing motor fluctuations - NA | Parkinson's Desease (PD) 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: EXN-44(LEVODOPA) Product Code: EXN-44 Trade Name: Sinemet Product Name: EXN-32 (CARBIDOPA E LEVODOPA) Product Code: EXN-32 | DR. REDDY’S LABORATORIES LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Italy | ||
| 68 | EUCTR2015-005814-31-BE (EUCTR) | 06/07/2017 | 05/05/2017 | - | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND | Subjects with advanced 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: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 2 | United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Hungary;Belgium;Poland;Germany | ||
| 69 | EUCTR2015-005814-31-ES (EUCTR) | 22/06/2017 | 21/04/2017 | - | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND | Subjects with advanced 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] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 2 | United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Hungary;Belgium;Poland;Germany | ||
| 70 | EUCTR2015-005814-31-HU (EUCTR) | 14/06/2017 | 20/04/2017 | - | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND | Subjects with advanced 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] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 2 | United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Belgium;Poland;Germany | ||
| 71 | EUCTR2015-005814-31-PL (EUCTR) | 25/05/2017 | 14/02/2017 | - | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND | Subjects with advanced 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: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 2 | United States;Czechia;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy;France | ||
| 72 | EUCTR2015-004507-23-FI (EUCTR) | 08/05/2017 | 30/03/2017 | Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations. | Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC | Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104 | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Finland;Latvia;Germany | ||
| 73 | 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 |
| 74 | 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 |
| 75 | EUCTR2016-001403-23-GR (EUCTR) | 31/03/2017 | 14/10/2016 | 12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease | An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study | Dyskinesia in advanced Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;European Union;Greece;Finland;Spain | ||
| 76 | 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 | ||
| 77 | EUCTR2015-005814-31-CZ (EUCTR) | 03/03/2017 | 01/12/2016 | - | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND | Subjects with advanced 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: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy | ||
| 78 | EUCTR2015-004507-23-HU (EUCTR) | 24/02/2017 | 04/01/2017 | Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations. | Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC | Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104 | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Finland;Latvia;Germany | ||
| 79 | EUCTR2016-001403-23-FI (EUCTR) | 22/02/2017 | 31/08/2016 | 12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease | An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study | Dyskinesia in advanced Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;European Union;Greece;Finland;Spain | ||
| 80 | NCT02799381 (ClinicalTrials.gov) | February 9, 2017 | 10/6/2016 | A Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease (DYSCOVER) | An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease DYSCOVER (DYSkinesia COmparative Interventional Trial on Duodopa VERsus Oral Medication) | Parkinson's Disease (PD) | Drug: Optimized antiparkinsonian treatment;Drug: Levodopa-Carbidopa Intestinal Gel (LCIG);Device: CADD-Legacy ambulatory infusion pump;Device: Percutaneous endoscopic gastrostomy tube;Device: Jejunal extension tube | AbbVie | NULL | Completed | 30 Years | N/A | All | 63 | Phase 3 | United States;Finland;Greece;Hungary;Italy;Slovakia;Spain |
| 81 | EUCTR2015-005814-31-DE (EUCTR) | 07/02/2017 | 24/05/2016 | - | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) | Subjects with advanced 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: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Germany | ||
| 82 | EUCTR2016-002033-30-BE (EUCTR) | 19/12/2016 | 21/11/2016 | A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations 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: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany | ||
| 83 | EUCTR2016-002033-30-FR (EUCTR) | 29/11/2016 | 12/01/2017 | A clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations 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] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Hungary;Canada;Belgium;Spain;Denmark;Israel;Netherlands;United Kingdom;Sweden | ||
| 84 | EUCTR2016-001403-23-SK (EUCTR) | 29/11/2016 | 07/09/2016 | 12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease | An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study | Dyskinesia in advanced Parkinson's disease MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;European Union;Slovakia;Greece;Finland;Spain | ||
| 85 | EUCTR2016-001403-23-ES (EUCTR) | 14/11/2016 | 15/11/2016 | 12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease | An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study | Dyskinesia in advanced Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Hungary;Slovakia;European Union;Greece;Finland;Spain | ||
| 86 | EUCTR2016-002033-30-ES (EUCTR) | 03/11/2016 | 25/08/2016 | A clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuations | A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO | Subjects with Parkinson’s Disease with motor fluctuations 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: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;France;Canada;Belgium;Spain;Denmark;Israel;Netherlands;Sweden | ||
| 87 | EUCTR2015-005078-39-DE (EUCTR) | 21/09/2016 | 02/03/2016 | - | A multicenter, parallel-group, rater-blinded, randomized clinical study investigating the efficacy, safety, tolerability and pharmacokinetics of 2 dosing regimens of ND0612H, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's disease | Subjects with advanced 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] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 47 | Phase 2 | United States;Austria;Israel;Germany;Italy | ||
| 88 | EUCTR2016-001403-23-IT (EUCTR) | 13/09/2016 | 06/09/2021 | 12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease. | An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparativeinterventional trial on Duodopa VERsus oral medication) - DYSCOVER Study | Dyskinesia in advanced 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] | Trade Name: Duodopa Product Name: na Product Code: [na] INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA MONOHYDRATE | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;Hungary;Slovakia;European Union;Greece;Finland;Spain;Italy | ||
| 89 | 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 | ||
| 90 | EUCTR2015-005814-31-AT (EUCTR) | 29/08/2016 | 11/05/2016 | - | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) | Subjects with advanced 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: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 2 | France;United States;Czechia;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy | ||
| 91 | 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 |
| 92 | 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 | ||
| 93 | EUCTR2015-005814-31-IT (EUCTR) | 23/06/2016 | 14/01/2021 | Not available | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND | advanced Parkinson's disease 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] | Product Name: Soluzione di levodopa/carbidopa Product Code: ND0612 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA (LD) INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA (CD) | NEURODERM LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 2 | France;United States;Czechia;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy | ||
| 94 | 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 | ||
| 95 | 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 | ||
| 96 | 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 | ||
| 97 | EUCTR2015-005078-39-IT (EUCTR) | 08/06/2016 | 19/01/2021 | NA | A multicenter, parallel-group, rater-blinded, randomized clinical studyinvestigating the efficacy, safety, tolerability and pharmacokinetics of2 dosing regimens of ND0612H, a solution of levodopa/carbidopadelivered via a pump system as a continuous subcutaneous infusion insubjects with advanced Parkinson's disease - NA | advanced 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: soluzione di levodopa/carbidopa Product Code: ND0612 INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA | NEURODERM LTD. | NULL | Not Recruiting | Female: yes Male: yes | 47 | Phase 2 | United States;Austria;Israel;Germany;Italy | ||
| 98 | NCT02812394 (ClinicalTrials.gov) | June 2016 | 22/6/2016 | A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets | A Phase 1 Single Dose Pharmacokinetic Bridging Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets | Parkinson Disease | Drug: CVT-301 (Dose Level 1);Drug: CVT-301 (Dose Level 2);Drug: Sinemet® | Acorda Therapeutics | NULL | Completed | 25 Years | 65 Years | Both | 24 | Phase 1 | United States |
| 99 | EUCTR2015-005078-39-AT (EUCTR) | 30/05/2016 | 09/03/2016 | - | A multicenter, parallel-group, rater-blinded, randomized clinical study investigating the efficacy, safety, tolerability and pharmacokinetics of 2 dosing regimens of ND0612H, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's disease | Subjects with advanced 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: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 47 | Phase 2 | United States;Austria;Israel;Germany;Italy | ||
| 100 | 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 | ||
| 101 | 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 | ||
| 102 | 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 | ||
| 103 | 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 | ||
| 104 | 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 | ||
| 105 | 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 | ||
| 106 | EUCTR2015-004507-23-DE (EUCTR) | 25/04/2016 | 13/01/2016 | Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations. | Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC | Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104 | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Hungary;Finland;Latvia;Germany | ||
| 107 | 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 | ||
| 108 | EUCTR2015-004507-23-LV (EUCTR) | 15/03/2016 | 13/01/2016 | Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations. | Efficacy and safety of ODM-104 compared to a standard combination (Stalevo); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson's disease and end-of-dose wearing-off. - COMPOC | Parkinson's disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Product Name: Levodopa 75 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 100 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 125 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Levodopa 150 mg A CAP INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Product Name: Carbidopa 65 mg capsule INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA Product Name: ODM-104 INN or Proposed INN: na Other descriptive name: ODM-104 | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Finland;Germany;Latvia | ||
| 109 | 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 |
| 110 | NCT02549092 (ClinicalTrials.gov) | October 26, 2015 | 11/9/2015 | A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD) | An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) THerapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects With Advanced Parkinson's Disease - INSIGHTS Study | Advanced Parkinson's Disease | Drug: Optimized Medical Treatment;Drug: Levodopa-Carbidopa Intestinal Gel;Device: Nasojejunal (NJ) tube;Device: Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube | AbbVie | NULL | Completed | 30 Years | N/A | All | 89 | Phase 3 | United States;Australia;Canada;Germany;Greece;Italy;Korea, Republic of;Spain;Sweden |
| 111 | EUCTR2014-004865-26-IT (EUCTR) | 21/09/2015 | 29/05/2015 | 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease | An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study | Non-motor symptoms in advanced Parkinson's disease MedDRA version: 18.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 88 | European Union;Canada;Spain;Australia;Germany;Italy;Sweden | |||
| 112 | EUCTR2014-004865-26-DE (EUCTR) | 27/08/2015 | 22/05/2015 | 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease | An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study | Non-motor symptoms in advanced Parkinson's disease MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 3 | European Union;Canada;Spain;Australia;Germany;Italy;Sweden | ||
| 113 | EUCTR2014-004865-26-SE (EUCTR) | 05/08/2015 | 25/05/2015 | 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease | An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study | Non-motor symptoms in advanced Parkinson's disease MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 3 | United States;European Union;Greece;Canada;Spain;Australia;Germany;Italy;Sweden | ||
| 114 | NCT02554734 (ClinicalTrials.gov) | August 2015 | 10/6/2015 | Pharmacokinetic Study in Healthy Volunteers | Pharmacokinetics of Levodopa After Repeated Doses of Carbidopa, ODM-104 and Levodopa: an Open, Randomised Study With Crossover Design in Healthy Males and Females | Parkinson's Disease | Drug: levodopa, carbidopa, ODM-104;Drug: levodopa, carbidopa, entacapone | Orion Corporation, Orion Pharma | NULL | Completed | 18 Years | 65 Years | Both | 15 | Phase 1 | Finland |
| 115 | EUCTR2014-004865-26-ES (EUCTR) | 19/06/2015 | 15/06/2015 | 26-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's Disease | An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease ? INSIGHTS Study - INSIGHTS Study | Non-motor symptoms in advanced Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA MONOHYDRATE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 3 | Greece;Canada;Sweden;European Union;Italy;Australia;Germany;Spain | ||
| 116 | NCT02448914 (ClinicalTrials.gov) | May 2015 | 12/5/2015 | A Study to Compare Plasma Levels of Levodopa, Carbidopa and Entacapone After TRIGEL or Duodopa Infusion in PD Patients | A Single Centre, Two-period, Open Label, Randomised, Cross-over Study to Assess Plasma Levodopa, Carbidopa and Entacapone Concentrations After Continuous Infusion of TRIGEL or Duodopa in Patients With Advanced Parkinson´s Disease | Parkinson's Disease | Drug: TRIGEL;Drug: Duodopa | LobSor Pharmaceuticals AB | TFS Trial Form Support | Completed | 30 Years | N/A | All | 11 | Phase 1 | Sweden |
| 117 | NCT02480803 (ClinicalTrials.gov) | December 19, 2014 | 4/5/2015 | INfusion VErsus STimulation in Parkinson's Disease | Treatment in Advanced Parkinson's Disease: Continuous Intrajejunal Levodopa INfusion VErsus Deep Brain STimulation | Parkinson's Disease | Drug: Continuous intrajejunal infusion of levodopa-carbidopa;Device: deep brain stimulation | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | ZonMw: The Netherlands Organisation for Health Research and Development | Active, not recruiting | 18 Years | N/A | All | 66 | Phase 4 | Netherlands |
| 118 | EUCTR2014-004501-32-NL (EUCTR) | 11/12/2014 | 03/12/2014 | Treatment in Advanced Parkinson's disease: a cost-effectiveness analysis of two different treatments | Infusion VErsus STimulation, a cost-effectiveness analysis of the treatment in advanced Parkinson's diseasecomparing Continuous Intrajejunal Levodopa Infusion to the traditional standard treetment Deep BrainStimulation; - INVEST (INfusion VErsus STimulation) | Patients with advanced PD who's motor symptoms — severe responsefluctuations, dyskinesias, painful dystonia and / or bradykinesia —cannot be controlled despite optimal oral pharmacological therapy.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa, levodopa 20 mg/ml + carbidopa 5 mg/ml, intestinal gel | Academic Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 119 | NCT02312232 (ClinicalTrials.gov) | November 2014 | 2/12/2014 | Pharmacokinetic Study in Healthy Males | Pharmacokinetics of Levodopa, Carbidopa, 3-OMD and ODM-104 After Repeated Doses of Different Formulations: an Open, Randomised, Multicentre Study With Crossover Design in Healthy Males | Parkinson's Disease | Drug: levodopa, carbidopa, ODM-104 | Orion Corporation, Orion Pharma | NULL | Completed | 18 Years | 65 Years | Male | 20 | Phase 1 | Finland |
| 120 | NCT02096601 (ClinicalTrials.gov) | August 2014 | 18/3/2014 | A Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients | A Phase I/II Pharmacokinetic (PK) Study of ND0612, a Liquid Formulation of Levodopa/Carbidopa (LD/CD), Delivered as a Continuous Subcutaneous in Parkinson's Disease (PD) Patients Treated With LD | Parkinson's Disease | Drug: Levodopa and carbidopa SC solution;Drug: Oral levodopa and carbidopa | NeuroDerm Ltd. | Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | 80 Years | All | 16 | Phase 1/Phase 2 | United States;Israel |
| 121 | NCT01883505 (ClinicalTrials.gov) | December 2013 | 9/6/2013 | A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612 | A Phase 2a Multicentre Randomized Double Blind Placebo Controlled Study Followed by an Open Label Period, to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations, Administered With Repeated Continuous Subcutaneous ND0612 | Parkinson's Disease | Drug: Levodopa and carbidopa;Drug: Placebo | NeuroDerm Ltd. | NULL | Completed | 30 Years | N/A | Both | 30 | Phase 2 | Israel |
| 122 | NCT01960842 (ClinicalTrials.gov) | October 2013 | 9/10/2013 | A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian Medications | An Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medication | Advanced Parkinson's Disease | Drug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tube | AbbVie | NULL | Completed | 30 Years | N/A | All | 31 | Phase 3 | Japan;Korea, Republic of;Taiwan |
| 123 | NCT01736176 (ClinicalTrials.gov) | March 2013 | 27/11/2012 | A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's Disease | An Open-Label, Two Part, Multicenter Study to Assess the Safety and Efficacy of Levodopa-Carbidopa Intestinal Gel (LCIG) for the Treatment of Non-Motor Symptoms in Subjects With Advanced Parkinson's Disease | Advanced Parkinson's Disease | Drug: Levodopa-Carbidopa Intestinal Gel;Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J);Drug: Levodopa-carbidopa Immediate Release (LC-IR) Tablets | AbbVie (prior sponsor, Abbott) | NULL | Completed | 30 Years | N/A | All | 39 | Phase 3 | United States |
| 124 | NCT01725802 (ClinicalTrials.gov) | December 2012 | 4/11/2012 | A Phase I/IIa Study of Safety, Tolerability and Plasma Concentration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients | A Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients | Parkinson's Disease | Drug: levodopa and carbidopa solution for SC administration;Drug: Placebo | NeuroDerm Ltd. | NULL | Completed | 30 Years | N/A | Both | 8 | Phase 1/Phase 2 | Israel |
| 125 | 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 |
| 126 | NCT01617135 (ClinicalTrials.gov) | May 2012 | 7/5/2012 | Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and Off Episodes | A Randomized, Placebo-Controlled, Phase 2 Study of the Safety, Pharmacokinetics and Pharmacodynamics of CVT-310 (Levodopa Inhalation Powder) in Patients With Parkinson's Disease and Motor Response Fluctuations (Off Episodes) | Idiopathic Parkinson's Disease | Drug: CVT-301;Drug: Placebo;Drug: Sinemet (carbidopa/levodopa) | Acorda Therapeutics | Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | N/A | All | 25 | Phase 2 | Israel;Serbia;United Kingdom |
| 127 | EUCTR2012-000181-37-GB (EUCTR) | 25/04/2012 | 27/02/2012 | A study investigating the safety of CVT-301 in patients with Parkinson's Disease | A Randomized, Placebo-Controlled Phase 2 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CVT-301 (Levodopa Inhalation Powder) in Patients with Parkinson’s Disease and Motor Response Fluctuations (Off” Episodes) | Parkinson's Disease MedDRA version: 14.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CVT-301 Product Code: CVT-301 INN or Proposed INN: LEVODOPA Trade Name: Sinemet® Product Name: SINEMET® Plus 25 mg/100 mg Tablets INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE | Civitas Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Serbia;Israel;United Kingdom | ||
| 128 | NCT01515410 (ClinicalTrials.gov) | January 2012 | 11/1/2012 | Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations | A Phase 2, Randomized, Open-Label, Crossover Study to Compare DM-1992, a Novel Gastric-Retentive Extended-Release Formulation of Levodopa/Carbidopa, to an Immediate-Release Carbidopa Tablet in Patients With Advanced Parkinson's Disease With Motor Fluctuations | Parkinson's Disease;Motor Fluctuations | Drug: DM-1992;Drug: Sinemet IR | Depomed | NULL | Completed | 30 Years | N/A | All | 34 | Phase 2 | United States |
| 129 | NCT01411137 (ClinicalTrials.gov) | August 2011 | 4/8/2011 | Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study | An Open Label Conversion Study of Carbidopa-Levodopa (CD-LD) Extended-Release Taken Alone or in Combination With CD-LD Immediate Release to IPX066 Followed by an Open-Label Extension Safety Study of IPX066 in Advanced PD | Parkinson's Disease | Drug: IPX066 | Impax Laboratories, LLC | Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | N/A | All | 43 | Phase 3 | United States |
| 130 | EUCTR2010-022200-46-LV (EUCTR) | 21/06/2011 | 01/04/2011 | Efficacy and safety of ODM-101 compared to a standard combination(Stalevo®) in patients with Pakinson's disease. | Efficacy and safety of ODM-101 compared to a standard combination(Stalevo®); a randomised, double-blind, crossover, proof of conceptstudy in patients with Parkinson's disease and end-of-dose motorfluctuations. - PARPOC | Parkinson's disease 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] | Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Finland;Lithuania;Germany;Latvia | |||
| 131 | NCT01528592 (ClinicalTrials.gov) | June 2011 | 31/1/2012 | PharmacoMRI of Parkinson Disease | A Pilot Study of the Drug Effects on Brain Connectivity of Parkinson's Disease | Parkinson's Disease | Drug: Carbidopa-Levodopa | Northwestern University | NULL | Completed | 30 Years | N/A | All | 18 | N/A | United States |
| 132 | EUCTR2010-022200-46-FI (EUCTR) | 13/05/2011 | 23/03/2011 | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Parkinson’s disease. | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC | Parkinson's disease MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Finland;Germany;Latvia;Lithuania | |||
| 133 | EUCTR2010-022200-46-LT (EUCTR) | 09/05/2011 | 05/04/2011 | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Parkinson’s disease. | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC | Parkinson's disease MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Finland;Lithuania;Germany;Latvia | |||
| 134 | NCT01766258 (ClinicalTrials.gov) | May 2011 | 22/11/2012 | Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations | Efficacy and Safety of ODM-101 Compared to a Standard Combination (Stalevo®); a Randomised, Double-blind, Crossover, Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations | Parkinson's Disease | Drug: ODM-101 65mg Carbidopa;Drug: ODM-101 105mg Carbidopa;Drug: Stalevo | Orion Corporation, Orion Pharma | NULL | Completed | 30 Years | N/A | Both | 117 | Phase 2 | NULL |
| 135 | NCT01227655 (ClinicalTrials.gov) | March 2011 | 22/10/2010 | Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients. | Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Study. | Parkinson's Disease | Drug: BIA 9-1067;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa;Drug: Benserazide | Bial - Portela C S.A. | NULL | Completed | 30 Years | 83 Years | All | 427 | Phase 3 | Portugal |
| 136 | NCT01568073 (ClinicalTrials.gov) | March 2011 | 29/3/2012 | Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon | Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo- and Active-controlled, Parallel-group, Multicentre Clinical Study | Parkinson's Disease | Drug: BIA 9-1067;Drug: Entacapone;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa;Drug: Benserazide | Bial - Portela C S.A. | NULL | Completed | 30 Years | 83 Years | All | 600 | Phase 3 | Portugal;Austria |
| 137 | EUCTR2008-001329-33-GB (EUCTR) | 24/02/2011 | 15/03/2010 | Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease | Open-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies. | Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel INN or Proposed INN: levodopa Other descriptive name: Ph. Eur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: carbidopa monohydrate Other descriptive name: Ph. Eur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylprop acid | AbbVie Inc | NULL | Not Recruiting | Female: yes Male: yes | 275 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Czech Republic;Thailand;Poland;Australia;Israel;Russian Federation;Italy;New Zealand;United Kingdom | ||
| 138 | NCT01296464 (ClinicalTrials.gov) | February 2011 | 14/2/2011 | Comparing Different Levodopa/Carbidopa/Entacapone Treatment Regimens | Duration of Motor Response After Administration of Experimental Levodopa/Carbidopa/Entacapone Treatment Regimens Compared to Standard Treatment (Stalevo®);a Randomised,Double-blind,Crossover,Multicentre,Single Dose Study in Patients With Parkinson?s Disease and Wearing-off Symptoms | Parkinson's Disease | Drug: Carbidopa | Orion Corporation, Orion Pharma | NULL | Completed | 30 Years | N/A | Both | 27 | Phase 2 | Finland;Sweden |
| 139 | EUCTR2010-022915-21-SE (EUCTR) | 12/01/2011 | 18/11/2010 | Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST | Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST | Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: carbidopa 20 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Product Name: carbidopa 27.5 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Trade Name: Stalevo 100/25/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE Other descriptive name: NA Trade Name: Stalevo 150/37.5/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 27 | Finland;Sweden | |||
| 140 | EUCTR2010-022915-21-FI (EUCTR) | 10/01/2011 | 11/11/2010 | Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST | Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST | Parkinson's disease MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Name: carbidopa 20 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Product Name: carbidopa 27.5 mg Product Code: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA Trade Name: Stalevo 100/25/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE Other descriptive name: NA Trade Name: Stalevo 150/37.5/200 mg Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA Other descriptive name: NA INN or Proposed INN: CARBIDOPA Other descriptive name: NA INN or Proposed INN: ENTACAPONE | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 27 | Finland;Sweden | |||
| 141 | NCT01229332 (ClinicalTrials.gov) | January 2011 | 3/10/2010 | A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients | A Phase I/II, Single-center, Randomized, Cross-over, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Administration of Subcutaneous Continuously-delivered Carbidopa Solution (ND0611) on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease | Drug: Saline;Drug: Carbidopa | NeuroDerm Ltd. | NULL | Completed | 30 Years | N/A | Both | 24 | Phase 1/Phase 2 | Israel |
| 142 | EUCTR2009-017238-39-DE (EUCTR) | 16/09/2010 | 28/07/2010 | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson’s Disease | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson’s Disease | Idiopathic Parkinson’s Disease (paralysis agitans) MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax) | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 3 | France;Belgium;Germany;Italy | ||
| 143 | EUCTR2009-017238-39-FR (EUCTR) | 15/09/2010 | 09/07/2010 | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease | Idiopathic Parkinson’s Disease (paralysis agitans) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax) | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 3 | France;Belgium;Germany;Italy | ||
| 144 | EUCTR2009-017238-39-BE (EUCTR) | 27/08/2010 | 14/07/2010 | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease | Idiopathic Parkinson’s Disease (paralysis agitans) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: Nacom 100 INN or Proposed INN: CARBIDOPA | Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax) | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 3 | France;Belgium;Germany;Italy | ||
| 145 | EUCTR2009-017182-38-ES (EUCTR) | 26/07/2010 | 25/05/2010 | Estudio abierto de extensión para evaluar la seguridad y la eficacia de IPX066 en la enfermedad de Parkinson.An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson?s Disease. | Estudio abierto de extensión para evaluar la seguridad y la eficacia de IPX066 en la enfermedad de Parkinson.An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson?s Disease. | Enfermedad de Parkinson idiopática (parálisis agitante) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc. acting through its Impax Pharmaceuticals Division | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Estonia;Poland;Spain;Lithuania;Germany;Latvia | ||
| 146 | EUCTR2009-017182-38-LT (EUCTR) | 10/07/2010 | 26/04/2010 | An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease | An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease | Idiopathic Parkinson´s disease (paralysis agitans) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax) | NULL | Not Recruiting | Female: yes Male: yes | 500 | Germany;Estonia;Spain;Latvia;Poland;Lithuania | |||
| 147 | EUCTR2009-017182-38-DE (EUCTR) | 09/07/2010 | 07/05/2010 | An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease. | An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease. | Idiopathic Parkinson’s disease (paralysis agitans). MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc. acting through its Impax Pharmaceuticals Division | NULL | Not Recruiting | Female: yes Male: yes | 500 | Estonia;Spain;Poland;Lithuania;Latvia;Germany | |||
| 148 | EUCTR2009-017182-38-PL (EUCTR) | 07/07/2010 | 20/05/2010 | An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease. | An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease. | Idiopathic Parkinson’s disease (paralysis agitans). MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Germany;Estonia;Spain;Latvia;Poland;Lithuania | |||
| 149 | NCT01171313 (ClinicalTrials.gov) | July 2010 | 26/7/2010 | A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects | A Phase 2 Efficacy, Safety and Pharmacokinetic Study of XP21279 BL2 and Sinemet® in Parkinson's Disease Subjects With Motor Fluctuations | Parkinson's Disease | Drug: XP21279 and carbidopa (experimental);Drug: Sinemet (comparator);Drug: Placebo for XP21279 and carbidopa;Drug: Placebo for Sinemet | XenoPort, Inc. | NULL | Completed | 30 Years | 80 Years | All | 35 | Phase 2 | United States |
| 150 | EUCTR2009-017238-39-IT (EUCTR) | 21/06/2010 | 13/07/2010 | A Study to Compare IPX066 and Carbidopa / Levodopa / Entacapone (CLE) in Advanced Parkinson’s Disease - ND | A Study to Compare IPX066 and Carbidopa / Levodopa / Entacapone (CLE) in Advanced Parkinson’s Disease - ND | Idiopathic Parkinson’s Disease (paralysis agitans) MedDRA version: 9.1;Level: LLT;Classification code 10061536 | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA LEVODOPA Trade Name: NACOM 100 INN or Proposed INN: Levodopa and decarboxylase inhibitor Trade Name: COMTAN INN or Proposed INN: Entacapone | IMPAX LABORATORIES, INC. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Germany;France;Italy | |||
| 151 | EUCTR2009-017182-38-LV (EUCTR) | 11/06/2010 | 26/04/2010 | An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease | An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease | Idiopathic Parkinson´s disease (paralysis agitans) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax) | NULL | Not Recruiting | Female: yes Male: yes | 500 | Germany;Estonia;Spain;Latvia;Poland;Lithuania | |||
| 152 | EUCTR2009-017182-38-EE (EUCTR) | 14/05/2010 | 26/04/2010 | An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease | An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease | Idiopathic Parkinson´s disease (paralysis agitans) MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax) | NULL | Not Recruiting | Female: yes Male: yes | 500 | Germany;Estonia;Spain;Latvia;Poland;Lithuania | |||
| 153 | NCT01130493 (ClinicalTrials.gov) | May 2010 | 24/5/2010 | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 | A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson's Disease | Parkinson's Disease | Drug: IPX066;Drug: CLE | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 110 | Phase 3 | United States;France;Germany;Italy |
| 154 | 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 |
| 155 | EUCTR2009-014688-37-PL (EUCTR) | 09/02/2010 | 20/01/2010 | A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson’s Disease - N/A | A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson’s Disease - N/A | Advanced Parkinson’s Disease subjects with motor fluctuations MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: SINEMET®-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA | Impax Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Germany;France;Spain;Poland | |||
| 156 | 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 | ||||
| 157 | EUCTR2008-001329-33-CZ (EUCTR) | 18/01/2010 | 03/12/2009 | Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease | Open-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies. | Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies MedDRA version: 16.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel INN or Proposed INN: levodopa Other descriptive name: Ph. Eur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: carbidopa monohydrate Other descriptive name: Ph. Eur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylprop acid | AbbVie Inc | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 3 | Portugal;Czech Republic;Poland;Thailand;Australia;Russian Federation;Israel;United Kingdom;New Zealand;Italy | ||
| 158 | EUCTR2009-014688-37-ES (EUCTR) | 30/12/2009 | 21/10/2009 | A Study To Evaluate The Safety And Efficacy Of IPX066 in Advanced Parkinsons DiseaseEstudio para evaluar la seguridad y eficacia de IPX066 en la enfermedad de Parkinson avanzada. | A Study To Evaluate The Safety And Efficacy Of IPX066 in Advanced Parkinsons DiseaseEstudio para evaluar la seguridad y eficacia de IPX066 en la enfermedad de Parkinson avanzada. | Advanced Parkinsons Disease subjects with motor fluctuationsEnfermedad de Parkinson avanzada en sujetos con fluctuaciones motoras MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: Sinemet-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA | Impax Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Germany;France;Spain;Poland | |||
| 159 | EUCTR2009-014688-37-DE (EUCTR) | 15/12/2009 | 07/10/2009 | A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease | A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease | Advanced Parkinson’s Disease subjects with motor fluctuations MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: SINEMET®-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA | Impax Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Germany;France;Spain;Poland | |||
| 160 | EUCTR2009-012897-12-RO (EUCTR) | 08/12/2009 | 30/03/2015 | A double-blind, randomised, placebo-controlled study to investigate the tolerability and the effect of three multiple-dose regimens of BIA 9-1067 on the levodopa pharmacokinetics, catechol-0-methyltransferase activity and motor response in parkinson´s disease patients treated with levodopa/dopa-decarboxylaseinhibitor | A double-blind, randomised, placebo-controlled study to investigate the tolerability and the effect of three multiple-dose regimens of BIA 9-1067 on the levodopa pharmacokinetics, catechol-0-methyltransferase activity and motor response in parkinson´s disease patients treated with levodopa/dopa-decarboxylaseinhibitor | Parkinson’s Disease MedDRA version: 17.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 | Product Name: BIA 9-1067 Product Code: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 Trade Name: SINEMET 25/100 INN or Proposed INN: LEVODOPA Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Restex Tabletten INN or Proposed INN: LEVODOPA INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE | BIAL-Portela & Ca, SA | NULL | Not Recruiting | Female: yes Male: yes | 32 | Romania | |||
| 161 | EUCTR2009-014688-37-FR (EUCTR) | 04/12/2009 | 09/10/2009 | A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease | A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease | Advanced Parkinson’s Disease subjects with motor fluctuations MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: SINEMET®-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | France;Poland;Spain;Germany | ||
| 162 | NCT01070628 (ClinicalTrials.gov) | December 2009 | 23/11/2009 | Levodopa Concentration Profile With Stalevo 75/125 mg | Levodopa Concentration Profile After Repeated Doses of Different Stalevo® Strengths With 3.5 Hours Dosing Frequency; an Open, Randomised, Crossover, Levodopa/Carbidopa Controlled Single Centre Study in Healthy Subjects, Two Parallel Groups | Parkinson's Disease | Drug: Stalevo (levodopa/ carbidopa/ entacapone);Drug: Sinemet (levodopa/carbidopa) | Orion Corporation, Orion Pharma | NULL | Completed | 18 Years | 70 Years | Both | 20 | Phase 1 | Finland |
| 163 | NCT00660387 (ClinicalTrials.gov) | December 2009 | 15/4/2008 | Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects | A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations | Advanced Parkinson's Disease | Drug: Levodopa carbidopa intestinal gel (LCIG);Drug: Placebo Gel;Drug: Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets;Drug: Placebo (PBO) oral capsules;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tube | AbbVie (prior sponsor, Abbott) | Quintiles, Inc. | Completed | 30 Years | N/A | All | 35 | Phase 3 | United States;New Zealand |
| 164 | NCT00660673 (ClinicalTrials.gov) | November 13, 2009 | 15/4/2008 | Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced PD | Open-Label Continuation Treatment Study With Levodopa - Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies | Advanced Parkinson's Disease | Drug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pump | AbbVie | IQVIA, formerly Quintiles | Completed | 30 Years | 99 Years | All | 262 | Phase 3 | United States;Australia;Canada;Czechia;Israel;New Zealand;Poland;Portugal;Russian Federation;Thailand;United Kingdom;Czech Republic |
| 165 | EUCTR2008-001329-33-PT (EUCTR) | 02/10/2009 | 19/08/2009 | Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease | Open-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies. | Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel INN or Proposed INN: levodopa Other descriptive name: Ph. Eur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: carbidopa monohydrate Other descriptive name: Ph. Eur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylprop acid | AbbVie Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 275 | Portugal;Czech Republic;Thailand;Poland;Australia;Israel;Russian Federation;Italy;United Kingdom;New Zealand | |||
| 166 | EUCTR2006-005186-18-NL (EUCTR) | 25/09/2009 | 29/05/2008 | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Solvay Pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy | |||
| 167 | 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 |
| 168 | EUCTR2009-010193-38-LV (EUCTR) | 04/06/2009 | 24/08/2009 | A Placebo-Controlled 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 | Idiopathic Parkinson's disease (paralysis agitans) MedDRA version: 9.1;Level: LLT;Classification code 10034010;Term: Parkinsonism | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA | IMPAX Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Estonia;Latvia;Lithuania | |||
| 169 | EUCTR2009-010193-38-LT (EUCTR) | 02/06/2009 | 26/03/2009 | A Placebo-Controlled 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 | Idiopathic Parkinson's disease (paralysis agitans) MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA | IMPAX Pharmaceuticals a Division of IMPAX Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Estonia;Latvia;Lithuania | |||
| 170 | NCT00360568 (ClinicalTrials.gov) | June 2009 | 3/8/2006 | Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects | Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects | Dyskinesias;Parkinson's Disease;Severe Motor Fluctuations | Drug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tube | AbbVie (prior sponsor, Abbott) | Quintiles, Inc. | Completed | 30 Years | N/A | All | 62 | Phase 3 | United States;Germany;New Zealand |
| 171 | EUCTR2006-000578-53-DE (EUCTR) | 08/05/2009 | 30/10/2008 | Open-Label, 12-Month Safety and Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects | Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 14.1;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: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel Product Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Abbott Laboratories | NULL | Not Recruiting | Female: yes Male: yes | 70 | United States;Germany;New Zealand | |||
| 172 | EUCTR2009-010193-38-EE (EUCTR) | 07/05/2009 | 15/04/2009 | A Placebo-Controlled 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 | Idiopathic Parkinson's disease (paralysis agitans) MedDRA version: 9.1;Level: LLT;Classification code 10034010;Term: Parkinsonism | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA | IMPAX Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Estonia;Latvia;Lithuania | |||
| 173 | NCT00914602 (ClinicalTrials.gov) | May 2009 | 3/6/2009 | An Exploratory Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects | An Exploratory Pharmacokinetic, Pharmacodynamic and Safety Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects With Motor Fluctuations | Parkinson's Disease | Drug: Sinemet 25-100 Oral Tablet;Drug: XP21279;Drug: Carbidopa Pill | XenoPort, Inc. | NULL | Completed | 30 Years | 75 Years | All | 14 | Phase 1/Phase 2 | United States |
| 174 | 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 |
| 175 | NCT01399905 (ClinicalTrials.gov) | March 2009 | 21/7/2011 | High and Low Dose Carbidopa Treatment of Parkinson's Disease | A Randomized Controlled Trial of Four Week Outpatient Treatment of Parkinson's Disease Comparing High and Low Dose Carbidopa. | Parkinson's Disease | Drug: carbidopa | Oregon Health and Science University | NULL | Completed | 35 Years | 85 Years | All | 14 | Phase 2 | United States |
| 176 | EUCTR2006-005186-18-CZ (EUCTR) | 09/02/2009 | 21/11/2007 | Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s Disease | An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 14.1;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: DUODOPA®Intestinal Gel Product Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Abbott Healthcare Products B.V. | NULL | Not Recruiting | Female: yes Male: yes | 320 | United States;Portugal;Finland;Thailand;Spain;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Canada;Poland;Australia;Germany;Netherlands;New Zealand | |||
| 177 | NCT00357994 (ClinicalTrials.gov) | January 2009 | 27/7/2006 | Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects | A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations | Advanced Parkinson's Disease | Drug: Levodopa carbidopa intestinal gel (LCIG);Drug: Placebo gel;Drug: Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets;Drug: Placebo (PBO) oral capsules;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tube | AbbVie (prior sponsor, Abbott) | Quintiles, Inc. | Completed | 30 Years | N/A | All | 36 | Phase 3 | United States;Germany |
| 178 | EUCTR2006-005186-18-GB (EUCTR) | 19/11/2008 | 27/06/2008 | Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s Disease | An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 14.1;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: DUODOPA®Intestinal Gel Product Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Abbott Healthcare Products B.V. | NULL | Not Recruiting | Female: yes Male: yes | 320 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Finland;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Poland;Australia;Netherlands;Germany;New Zealand | ||
| 179 | NCT00869791 (ClinicalTrials.gov) | November 2008 | 24/3/2009 | A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa | A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa | Parkinson's Disease | Drug: IPX066;Drug: IR CD-LD | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 27 | Phase 2 | United States |
| 180 | EUCTR2008-003869-72-PT (EUCTR) | 03/10/2008 | 25/06/2008 | 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 | 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 MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Product Code: BIA 9-1067 Trade Name: SINEMET 25/100 INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Code: BIA 9-1067 | Bial - Portela & Cª, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 12 | Portugal | |||
| 181 | EUCTR2006-005186-18-DE (EUCTR) | 30/09/2008 | 13/11/2008 | Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s Disease | An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 14.1;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: DUODOPA®Intestinal Gel Product Name: Duodopa INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Abbott Healthcare Products B.V. | NULL | Not Recruiting | Female: yes Male: yes | 320 | Portugal;United States;Finland;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Poland;Australia;Netherlands;Germany;New Zealand | |||
| 182 | EUCTR2004-005234-39-DE (EUCTR) | 11/08/2008 | 02/12/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 244 | Finland;United Kingdom;Germany;Denmark;Ireland;Latvia;Lithuania;Sweden | |||
| 183 | NCT00601978 (ClinicalTrials.gov) | August 2008 | 11/1/2008 | Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease (PD) and End-of-dose Wearing Off | A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event-Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease and End-of-Dose Wearing Off | Parkinson's Disease | Drug: carbidopa/levodopa;Drug: Carbidopa/Levodopa/Entacapone | Novartis Pharmaceuticals | NULL | Withdrawn | 45 Years | 75 Years | Both | 0 | Phase 4 | United States |
| 184 | NCT00745277 (ClinicalTrials.gov) | August 2008 | 2/9/2008 | High and Low Dose Treatment of Carbidopa in Parkinson's Disease | A Randomized Controlled Trial of Four Week Outpatient Treatment of Parkinson's Disease Comparing High and Low Dose Carbidopa. | Parkinson's Disease | Drug: Carbidopa-Levodopa;Drug: Carbidopa- Levodopa | Oregon Health and Science University | Parkinson Disease Research, Education and Clinical Center at Portland VA Hospital;RJG Foundation;Oregon Clinical and Translational Research Institute | Completed | 35 Years | 85 Years | Both | 12 | Phase 2 | United States |
| 185 | EUCTR2008-003581-26-SE (EUCTR) | 18/07/2008 | 30/05/2008 | Pharmacokinetics of levodopa using duodenal levodopa/carbidopa infusion with and without oral COMT inhibitors - DuoCOMT | Pharmacokinetics of levodopa using duodenal levodopa/carbidopa infusion with and without oral COMT inhibitors - DuoCOMT | Parkinson's disease (G20.9), advanced, patients presently on Duodopa treatment. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Duodopa INN or Proposed INN: levodopa INN or Proposed INN: carbidopa Trade Name: Comtess INN or Proposed INN: entacapone Trade Name: Tasmar INN or Proposed INN: tolcapone | Dept of Neuroscience, Uppsala University | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Sweden | ||||
| 186 | EUCTR2007-003134-42-DE (EUCTR) | 19/06/2008 | 20/02/2008 | A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off. | A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off. | Idiopathic Parkinson’s disease and end-of-dose wearing off. MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo 100 mg/ 25 mg/ 200 mg Filmtabletten Product Name: Stalevo INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA INN or Proposed INN: ENTACAPONE Trade Name: Nacom 100 Product Name: Nacom INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA MONOHYDRATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Germany | |||
| 187 | EUCTR2007-005033-11-DE (EUCTR) | 27/03/2008 | 04/01/2008 | A Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s Disease | A Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s Disease | Patients with Parkinson's Disease | Product Name: Levodopa-Carbidopa Multilayer Extended Release Tablet Product Code: Levodopa-Carbidopa XL tablet (M) INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet® CR Product Name: Sinemet CR INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | CombinatoRx, Inc | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 188 | EUCTR2006-005186-18-PT (EUCTR) | 07/03/2008 | 14/11/2007 | An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” | An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Abbott Healthcare Products B.V. | NULL | Not Recruiting | Female: yes Male: yes | 320 | Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy | |||
| 189 | NCT00642356 (ClinicalTrials.gov) | March 2008 | 19/3/2008 | Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off | An 8-week, Prospective, Randomized, Double-blind, Double-dummy, Active-controlled, Multi-center Comparison Study of the Effects of Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off | Parkinson's Disease | Drug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopa | Novartis | NULL | Terminated | 30 Years | 85 Years | All | 14 | Phase 4 | United States |
| 190 | EUCTR2006-005186-18-IT (EUCTR) | 08/02/2008 | 14/11/2007 | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa ? Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations - ND | Parkinson Disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Duodopa gel intestinale INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Solvay Pharmaceuticals BV. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Portugal;Finland;Germany;United Kingdom;Czech Republic;Netherlands;Spain;Italy | ||||
| 191 | EUCTR2006-005186-18-ES (EUCTR) | 23/01/2008 | 29/11/2007 | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-FluctuationsEstudio abierto de 6-12 meses de duración que evaluará la seguridad y eficacia de un gel intestinal de Levodopa-Carbidopa en pacientes con enfermedad de Parkinson avanzada que responde a Levodopa y fluctuaciones motoras severas | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-FluctuationsEstudio abierto de 6-12 meses de duración que evaluará la seguridad y eficacia de un gel intestinal de Levodopa-Carbidopa en pacientes con enfermedad de Parkinson avanzada que responde a Levodopa y fluctuaciones motoras severas | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.Tratamiento de la enfermedad de Parkinson avanzada que responde a Levidopa con fluctuaciones motoras severas MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Solvay Pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy | ||
| 192 | NCT00562198 (ClinicalTrials.gov) | January 2008 | 19/11/2007 | PET-Study: Effects of Single Doses of Stalevo and Levodopa/Carbidopa on Striatal 11C-Raclopride Binding | Effects of Single Doses of Stalevo 200 and Levodopa/Carbidopa 200/50mg on Striatal 11C-Raclopride Binding Potential in Parkinson's Disease Patients With Wearing-Off Symptoms;an Open, Randomised, Active-Controlled,Two-Period Crossover Study. | Parkinson´s Disease | Drug: entacapone and carbidopa;Drug: Sinemet 200mg/50mg | Orion Corporation, Orion Pharma | NULL | Terminated | 45 Years | 80 Years | Both | 16 | Phase 2 | Finland |
| 193 | NCT00335153 (ClinicalTrials.gov) | January 2008 | 8/6/2006 | Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease | An Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Subjects With Advanced Parkinson's Disease and Severe Motor Fluctuations Despite Optimized Treatment With Available Parkinson's Disease Medications | Advanced Parkinson's Disease | Drug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tube | AbbVie (prior sponsor, Abbott) | Quintiles, Inc. | Completed | 30 Years | N/A | All | 354 | Phase 3 | United States;Australia;Canada;Czech Republic;Finland;Germany;Israel;Italy;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Spain;Thailand;United Kingdom;Greece |
| 194 | EUCTR2004-000185-12-GB (EUCTR) | 13/12/2007 | 11/02/2005 | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 740 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Finland;Austria;Italy;United Kingdom;Sweden | ||
| 195 | EUCTR2007-004985-41-SE (EUCTR) | 29/11/2007 | 10/10/2007 | Different dyskinesias in Parkinson's disease and their relation to levodopa pharmacokinetics - The dyskinesia study | Different dyskinesias in Parkinson's disease and their relation to levodopa pharmacokinetics - The dyskinesia study | Parkinson's disease, G20.9. Different dyskinesias related to advanced Parkinson's disease will be investigated. | Trade Name: Duodopa INN or Proposed INN: levodopa INN or Proposed INN: carbidopa | Department of Neuroscience, neurology | NULL | Not Recruiting | Female: yes Male: yes | Sweden | ||||
| 196 | EUCTR2006-005186-18-FI (EUCTR) | 16/11/2007 | 04/10/2007 | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations | Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid | Solvay Pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy | |||
| 197 | EUCTR2007-002496-14-FI (EUCTR) | 05/11/2007 | 14/09/2007 | Effects of single doses of Stalevo 200 and levodopa/carbidopa 200/50 mg on striatal 11C-raclopride binding potential in Parkinson’s disease patients with wearing-off symptoms. An open, randomised, active-controlled, two-period crossover study. | Effects of single doses of Stalevo 200 and levodopa/carbidopa 200/50 mg on striatal 11C-raclopride binding potential in Parkinson’s disease patients with wearing-off symptoms. An open, randomised, active-controlled, two-period crossover study. | Parkinson’s disease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: Stalevo® INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet® INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Product Name: 11C-Raclopride Other descriptive name: 11C-Raclopride | Orion Corporation Orion Pharma | NULL | Not Recruiting | Female: yes Male: yes | Finland | ||||
| 198 | NCT00558337 (ClinicalTrials.gov) | November 2007 | 12/11/2007 | Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Study of L-Dopa/Carbidopa To Treat Parkinson's Disease | An Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Relationship Study of L-Dopa/Carbidopa in a Novel Release Formulation in Parkinson's Disease Patients | Parkinson's Disease | Drug: levodopa-carbidopa | Osmotica Pharmaceutical Corp. | NULL | Completed | 30 Years | 80 Years | Both | 78 | Phase 2 | Argentina |
| 199 | NCT00547911 (ClinicalTrials.gov) | October 2007 | 19/10/2007 | Augmenting Effects of L-DOPS With Carbidopa and Entacapone | L-Dihydroxyphenylserine (L-DOPS) for Norepinephrine Deficiency: Interactions With Carbidopa and Entacapone | Parkinson Disease;Multiple System Atrophy;Autonomic Nervous System Diseases | Drug: Droxidopa;Drug: Carbidopa;Drug: Entacapone | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Terminated | 18 Years | N/A | All | 14 | Phase 1/Phase 2 | United States |
| 200 | NCT00460954 (ClinicalTrials.gov) | June 2007 | 16/4/2007 | A Multiple-Dose Study of Sinemet® CR (Carbidopa/Levodopa) in Healthy Subjects | An Open Label, Multiple-Dose Study ot Determine the Plasma Levodopa Profiles of Sinemet® CR (Carbidopa/Levodopa) at 4 Daily Dose Levels in Healthy Subjects | Parkinson's Disease | Drug: Sinemet® controlled release (Carbidopa/levodopa) | Bristol-Myers Squibb | NULL | Completed | 50 Years | 75 Years | Both | 20 | N/A | Canada |
| 201 | NCT00505843 (ClinicalTrials.gov) | May 2007 | 24/7/2007 | A Study of MK0657 in Parkinson's Disease Patients (0657-006) | A Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover Study to Evaluate Effectiveness of Single-Dose MK0657 in Combination With Levodopa on Motor Symptoms and Dyskinesias in Patients With Parkinson's Disease | Parkinson's Disease | Drug: MK0657;Drug: Comparator: Placebo (unspecified);Drug: Comparator: levodopa;Drug: Comparator: carbidopa | Merck Sharp & Dohme Corp. | NULL | Completed | 40 Years | 80 Years | Both | 18 | Phase 1 | United States |
| 202 | EUCTR2006-000577-29-DE (EUCTR) | 27/04/2007 | 12/10/2006 | Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson’s Subjects | A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson’s Subjects Receiving Optimized Treatments with Parkinson Medicinal Products who Continue toExperience Persistent Motor Fluctuations | Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. MedDRA version: 14.0;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: DUODOPA®Intestinal Gel INN or Proposed INN: Levodopa Other descriptive name: 3-(3,4-Dihydroxyphenyl)-L-alanine; L-3-(3,4-Dihydroxyphenyl)alanine; L-DOPA INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: (minus)-L-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid monohydrate Trade Name: Sinemet®25-100 INN or Proposed INN: Levodopa Other descriptive name: 3-(3,4-Dihydroxyphenyl)-L-alanine; L-3-(3,4-Dihydroxyphenyl)alanine; L-DOPA INN or Proposed INN: Carbidopa Monohydrate Other descriptive name: (minus)-L-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid monohydrate | Abbott Products, Inc (Abbott Products Inc. is part of the parent company, Abbott Laboratories) | NULL | Not Recruiting | Female: yes Male: yes | 31 | United States;Germany | |||
| 203 | EUCTR2006-005714-12-IT (EUCTR) | 27/02/2007 | 03/08/2007 | A randomized, double blind, placebo-controlled study to investigate the effect of E2007 on pharmacodynamic responses to levodopa among patients with Parkinson's disease who experience dyskinesia and motor fluctuations. - E2007-E044-213 | A randomized, double blind, placebo-controlled study to investigate the effect of E2007 on pharmacodynamic responses to levodopa among patients with Parkinson's disease who experience dyskinesia and motor fluctuations. - E2007-E044-213 | Patients with idiopathic Parkinson's disease who respond to levodopa treatment but who experience peak-effect levodopa-induced dyskinesia and end-of-dose 'wearing-off' motor fluctuations MedDRA version: 6.1;Level: HLT;Classification code 10034005 | Product Name: E2007 Product Code: E2007 INN or Proposed INN: OTHER NERVOUS SYSTEM DRUGS Trade Name: SINEMET INN or Proposed INN: levodopa-carbidopa | EISAI LTD UK | NULL | Not Recruiting | Female: yes Male: yes | 24 | Italy | |||
| 204 | EUCTR2006-002408-32-ES (EUCTR) | 27/02/2007 | 07/02/2007 | Modulación dopaminérgica de las funciones cognitivas y afectivas por el tratamiento con diferentes métodos de estimulación dopaminérgica en la enfermedad de Parkinson . Implicaciones para el tratamiento con levodopa. | Modulación dopaminérgica de las funciones cognitivas y afectivas por el tratamiento con diferentes métodos de estimulación dopaminérgica en la enfermedad de Parkinson . Implicaciones para el tratamiento con levodopa. | Fluctuaciones motoras, cognitivas y del humor en la enfermedad de Parkinson. MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo 150 Product Name: Levodopa-carbidopa-entacapone Trade Name: Sinemet Product Name: Levodopa/Carbidopa | Institut de Recerca del Hospital de la Santa Creu i Sant Pau | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Spain | |||
| 205 | EUCTR2005-002654-21-NO (EUCTR) | 28/12/2006 | 06/11/2006 | A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE | A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE | Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. | Trade Name: Duodopa intestinalgel INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Solvay Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 75 | Norway;Sweden | |||
| 206 | EUCTR2006-001755-36-GB (EUCTR) | 20/11/2006 | 29/09/2006 | Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE | Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE | Parkinson’s disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone | Orion Corporation Orion Pharma | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Germany;United Kingdom;Sweden | ||
| 207 | EUCTR2006-004112-51-IT (EUCTR) | 14/11/2006 | 04/12/2006 | A randomised, double-blind, double-dummy, two-period, cross-over study to determine the pharmacokinetics, pharmacodynamics and safety of multiple doses of V1512 effervescent tablets in Parkinson s Disease PD patients compared to standard levodopa/carbidopa Sinemet oral tablets - ND | A randomised, double-blind, double-dummy, two-period, cross-over study to determine the pharmacokinetics, pharmacodynamics and safety of multiple doses of V1512 effervescent tablets in Parkinson s Disease PD patients compared to standard levodopa/carbidopa Sinemet oral tablets - ND | Parkinson s disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: SIRIO*30CPR EFF 25MG+100MG INN or Proposed INN: Melevodopa and decarboxylase inhibitor Trade Name: SINEMET*50CPR 100MG+25MG INN or Proposed INN: LEVODOPA DC.IT FU INN or Proposed INN: CARBIDOPA FU | VERNALIS DEVELOPMENT LIMITED | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 208 | NCT00590122 (ClinicalTrials.gov) | October 2006 | 28/12/2007 | Parcopa Versus Carbidopa-Levodopa in a Single Dose Cross-Over Comparison Study | COMPARISON OF ORALLY DISSOLVING LEVODOPA (PARCOPA®) TO CONVENTIONAL ORAL LEVODOPA: A SINGLE DOSE, DOUBLE-BLIND, PLACEBO CONTROLLED, CROSS-OVER TRIAL | Parkinson's Disease | Drug: Parcopa;Drug: carbidopa-levodopa | Baylor College of Medicine | UCB Pharma | Completed | 31 Years | 80 Years | Both | 20 | Phase 4 | United States |
| 209 | EUCTR2004-005234-39-LV (EUCTR) | 06/09/2006 | 29/09/2006 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 244 | Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden | |||
| 210 | EUCTR2006-001755-36-SE (EUCTR) | 09/08/2006 | 30/06/2006 | Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE | Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE | Parkinson’s disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone | Orion Corporation Orion Pharma, FI-02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 100 | United Kingdom;Germany;Sweden | |||
| 211 | EUCTR2006-000680-28-ES (EUCTR) | 07/07/2006 | 22/05/2006 | Estudio multicéntrico, doble ciego, aleatorizado y de tres meses de seguimiento para evaluar la eficacia de levodopa/carbidopa/entacapona frente a levodopa/carbidopa en pacientes con enfermedad de Parkinson y wearing-off”A 3-months, multicenter, double-blind, randomized study to evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in Parkinson's disease patients with 'wearing-off' - DERBI | Estudio multicéntrico, doble ciego, aleatorizado y de tres meses de seguimiento para evaluar la eficacia de levodopa/carbidopa/entacapona frente a levodopa/carbidopa en pacientes con enfermedad de Parkinson y wearing-off”A 3-months, multicenter, double-blind, randomized study to evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in Parkinson's disease patients with 'wearing-off' - DERBI | Enfermedad de Parkinson (Parkinson Disease) | Trade Name: Stalevo 100 Product Name: Stalevo (levodopa/carbidopa/entacapona) INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA INN or Proposed INN: ENTACAPONA Trade Name: Sinemet plus Product Name: Sinemet plus (levodopa/carbidopa) INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Trade Name: Stalevo 150 Product Name: Stalevo (levodopa/carbidopa/entacapona) INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA INN or Proposed INN: ENTACAPONA | NOVARTIS FARMACEUTICA, S.A | NULL | Not Recruiting | Female: yes Male: yes | 200 | Spain | |||
| 212 | EUCTR2004-005234-39-LT (EUCTR) | 09/05/2006 | 24/03/2006 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 244 | Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Sweden;Lithuania | |||
| 213 | EUCTR2005-001032-72-PT (EUCTR) | 23/03/2006 | 11/11/2005 | A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step | A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step | Parkinson disease | Trade Name: Stalevo Product Code: ELC200 INN or Proposed INN: levodopa/carbidopa/entacapone Trade Name: SINEMET Product Name: sinemet INN or Proposed INN: levodopa/carbidopa | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 424 | Portugal;Czech Republic;Italy | |||
| 214 | NCT00141518 (ClinicalTrials.gov) | March 2006 | 30/8/2005 | Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact | A Long-term Health Economics Study of Intraduodenal Levodopa (Duodopa®) in Routine Care for Patients With Advanced Idiopathic Parkinson's Disease With Severe Motor Fluctuations and Hyper-/Dyskinesia | Advanced Idiopathic Parkinson's Disease | Drug: Levodopa-carbidopa intestinal gel (LCIG);Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: percutaneous endoscopic gastrostomy tube (PEG tube);Device: jejunal extension tube (J-tube) | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | 99 Years | All | 77 | Phase 4 | Norway;Sweden |
| 215 | EUCTR2005-001032-72-CZ (EUCTR) | 16/02/2006 | 12/01/2006 | A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step | A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step | Trade Name: Stalevo 100 mg/25 mg / 200 mg Product Code: ELC200 Trade Name: SINEMET CR Product Name: SINEMET CR | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 424 | Portugal;Czech Republic;Italy | ||||
| 216 | NCT00279825 (ClinicalTrials.gov) | January 2006 | 18/1/2006 | Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Compare IPX054 200 mg and 250 mg to CD-LD IR 200 (2x100) mg Tablets and CD-LD CR 200 mg Tablet in Subjects With Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: IPX054 200 mg;Drug: IPX054 250 mg;Drug: CD-LD IR;Drug: CD-LD CR;Drug: IPX054 200 mg Placebo;Drug: IPX054 250 mg Placebo;Drug: CD-LD IR Placebo;Drug: CD-LD CR Placebo | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 16 | Phase 2 | United States |
| 217 | EUCTR2005-001032-72-IT (EUCTR) | 25/11/2005 | 26/03/2007 | A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 t.i.d. vs. immediate release carbidopa/levodopa t.i.d. in Parkinsons disease patients requiring levodopa. | A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 t.i.d. vs. immediate release carbidopa/levodopa t.i.d. in Parkinsons disease patients requiring levodopa. | Parkinson s Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Trade Name: Stalevo INN or Proposed INN: ENTACAPONE INN INN or Proposed INN: LEVODOPA INN INN or Proposed INN: CARBIDOPA INN Trade Name: Sinemet INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA ANIDRA | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 424 | Portugal;Czech Republic;Italy | |||
| 218 | NCT00253084 (ClinicalTrials.gov) | November 2005 | 11/11/2005 | Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease | A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: IPX054 200 mg;Drug: CD-LD IR;Drug: IPX054 Placebo;Drug: CD-LD IR Placebo | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 12 | Phase 2 | United States |
| 219 | EUCTR2004-005234-39-IE (EUCTR) | 20/10/2005 | 16/08/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Finland;Ireland;Lithuania;Denmark;Latvia;Germany;United Kingdom;Sweden | ||
| 220 | EUCTR2004-005234-39-FI (EUCTR) | 22/09/2005 | 03/06/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 240 | Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden | |||
| 221 | EUCTR2005-002654-21-SE (EUCTR) | 08/08/2005 | 14/06/2005 | A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE | A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE | Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. | Trade Name: Duodopa intestinal gel INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Solvay Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | Sweden | ||||
| 222 | EUCTR2004-005234-39-DK (EUCTR) | 04/08/2005 | 31/05/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 240 | Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden | |||
| 223 | NCT00134966 (ClinicalTrials.gov) | August 2005 | 23/8/2005 | A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa | A 39 Week Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Effect of Fixed Dose Carbidopa/Levodopa/Entacapone 100 mg t.i.d. vs. Immediate Release Carbidopa/Levodopa 25/100 mg (t.i.d.) in Parkinson's Disease Patients Requiring Levodopa | Parkinson's Disease | Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg) | Novartis | NULL | Completed | 30 Years | 80 Years | All | 493 | Phase 3 | United States;Canada;Czechia;Israel;Italy;Poland;Portugal;Turkey;Czech Republic |
| 224 | 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 | |||
| 225 | NCT00143026 (ClinicalTrials.gov) | July 2005 | 31/8/2005 | Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United States | Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. | Parkinson's Disease | Drug: carbidopa, levodopa, entacapone | Novartis | NULL | Completed | 30 Years | N/A | All | 184 | Phase 4 | Australia;Philippines;Taiwan;Thailand |
| 226 | EUCTR2004-005234-39-SE (EUCTR) | 08/06/2005 | 02/05/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 240 | Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden | |||
| 227 | EUCTR2004-005234-39-GB (EUCTR) | 27/05/2005 | 22/03/2005 | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet | Orion Corporation, ORION PHARMA, Finland | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Finland;Ireland;Lithuania;Denmark;Latvia;Germany;United Kingdom;Sweden | ||
| 228 | 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 | |||
| 229 | 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 | |||
| 230 | NCT00129181 (ClinicalTrials.gov) | January 2005 | 9/8/2005 | Study of the Effects of Dopaminergic Medications on Dopamine Transporter Density in 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 | Parkinson Disease;Parkinsonian Syndrome | Drug: cabergoline;Drug: carbidopa/levodopa;Procedure: DATscan and SPECT imaging | Institute for Neurodegenerative Disorders | Pfizer;GE Healthcare | Completed | 40 Years | N/A | Both | 30 | N/A | Austria;Germany;Italy;Spain;United Kingdom |
| 231 | NCT00219284 (ClinicalTrials.gov) | January 2005 | 30/6/2005 | Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease | A Prospective, Multi-center, Randomized, Open-label Study With Blinded Raters to Evaluate the Effects of Immediate Versus Delayed Switch to Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease With End-of-dose Wearing Off | Parkinson's Disease With End of Dose Wearing Off | Drug: Carbidopa/levodopa/entacapone | Novartis Pharmaceuticals | NULL | Completed | 30 Years | 85 Years | All | 359 | Phase 4 | United States;Puerto Rico |
| 232 | EUCTR2004-000185-12-IT (EUCTR) | 02/12/2004 | 27/06/2005 | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo in patients with Parkinson's disease | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo in patients with Parkinson's disease | Parkinson's Disease MedDRA version: 6.1;Level: PT;Classification code 10061536 | Trade Name: Stalevo Product Name: NA Product Code: NA INN or Proposed INN: carbidopa INN or Proposed INN: levodopa INN or Proposed INN: entecapone Trade Name: Sinemet Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA (DC.IT) (FU) INN or Proposed INN: CARBIDOPA (FU) Trade Name: Stalevo Product Name: NA Product Code: NA INN or Proposed INN: carbidopa INN or Proposed INN: levodopa INN or Proposed INN: entecapone Trade Name: Sinemet Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA (DC.IT) (FU) INN or Proposed INN: CARBIDOPA (FU) Trade Name: Sinemet Product Name: NA Product Code: NA INN or Proposed INN: LEVODOPA (DC.IT) (FU) INN or Proposed INN: CARBIDOPA (FU) | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 740 | Finland;United Kingdom;Italy;Sweden | |||
| 233 | EUCTR2004-000185-12-AT (EUCTR) | 25/11/2004 | 21/10/2004 | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 740 | Finland;Austria;Italy;United Kingdom;Sweden | |||
| 234 | EUCTR2004-000185-12-SE (EUCTR) | 11/11/2004 | 03/09/2004 | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet Product Name: | Orion Corporation, ORION PHARMA, 02200 Espoo, Finland | NULL | Not Recruiting | Female: yes Male: yes | 740 | Finland;United Kingdom;Italy;Sweden | |||
| 235 | EUCTR2004-000185-12-FI (EUCTR) | 21/09/2004 | 23/07/2004 | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD | Parkinson's disease MedDRA version: 7.0;Level: LLT;Classification code 10061536 | Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Trade Name: Sinemet INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa | Orion Corporation, ORION PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 740 | Finland;United Kingdom;Italy;Sweden | |||
| 236 | NCT00099268 (ClinicalTrials.gov) | September 2004 | 10/12/2004 | Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy | A Long Term, Double-blind, Randomized, Parallel-group, Carbidopa/Levodopa Controlled, Multi-center Study to Evaluate the Effect of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy | Parkinson's Disease | Drug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopa | Novartis Pharmaceuticals | Orion Corporation, Orion Pharma | Completed | 30 Years | 70 Years | All | 747 | Phase 3 | United States;Austria;Belgium;Canada;Finland;France;Germany;Greece;Italy;Spain;Sweden;Switzerland;Turkey;United Kingdom |
| 237 | NCT00174239 (ClinicalTrials.gov) | July 2004 | 9/9/2005 | Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease. | A Double-Blind, Randomized, Comparative Study of Cabaser and Sinemet CR For The Treatment Of Nocturnal Disability In Levodopa -Treated Parkinson's Disease Patients. | Parkinson Disease | Drug: cabergoline;Drug: controlled-release levodopa / carbidopa | Pfizer | NULL | Terminated | 18 Years | 80 Years | Both | 220 | Phase 4 | Australia;Italy;Spain;United Kingdom |
| 238 | NCT00200447 (ClinicalTrials.gov) | March 2004 | 12/9/2005 | An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN) | Assessment of Carbidopa/l-Dopa and Carbidopa/l Dopa/Entacapone on Synaptic Dopamine in Parkinson's Patients: An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN) | Parkinson's Disease | Drug: carbidopa/l-dopa;Drug: carbidopa/l-dopa/entacapone;Drug: Stalevo;Procedure: [123I]-IBZM imaging | Molecular NeuroImaging | NULL | Completed | 30 Years | N/A | Both | 3 | Phase 2 | NULL |
| 239 | NCT00139867 (ClinicalTrials.gov) | January 2004 | 29/8/2005 | A Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease | A Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease | Parkinson's Disease | Drug: PARCOPA | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | Phase 3 | United States | |
| 240 | EUCTR2010-022200-46-DE (EUCTR) | 13/04/2011 | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Pakinson’s disease. | Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC | Parkinson's disease MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ODM-101 Product Code: 75 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 100 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na INN or Proposed INN: ENTACAPONE Other descriptive name: na Product Name: ODM-101 Product Code: 125 INN or Proposed INN: LEVODOPA Other descriptive name: na INN or Proposed INN: CARBIDOPA Other descriptive name: na | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Finland;Lithuania;Latvia;Germany | ||||
| 241 | EUCTR2006-001755-36-DE (EUCTR) | 15/08/2006 | Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE | Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE | Parkinson’s disease MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone Trade Name: Stalevo Product Name: Stalevo INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa INN or Proposed INN: Entacapone | Orion Corporation Orion Pharma | NULL | Not Recruiting | Female: yes Male: yes | 100 | United Kingdom;Germany;Sweden |