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 | NCT04990284 (ClinicalTrials.gov) | November 29, 2021 | 27/7/2021 | eArly levoDopa With Opicapone in Parkinson's paTients wIth 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. | Parkinson Disease | Drug: Opicapone;Drug: L-DOPA/DDCI | Bial - Portela C S.A. | NULL | Recruiting | 30 Years | N/A | All | 100 | Phase 4 | Germany;Italy;Portugal;Spain;United Kingdom |
| 2 | EUCTR2020-005011-52-PT (EUCTR) | 03/09/2021 | 29/03/2021 | Efficacy and Safety of Opicapone, as an Add-on to Stable L-DOPA Plus DDCI Therapy, in Early Idiopathic Parkinson’s Disease Patients: The EPSILON Study | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson’s Disease Patients, with an Open-Label ExtensionThe EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone - EPSILON | Early Idiopathic 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: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: OPICAPONE | BIAL – Portela & Cª, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 324 | Phase 3 | Portugal;Serbia;Czechia;Spain;Ukraine;Turkey;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Bulgaria;Germany | ||
| 3 | EUCTR2020-005011-52-BE (EUCTR) | 19/07/2021 | 07/04/2021 | Efficacy and Safety of Opicapone, as an Add-on to Stable L-DOPA Plus DDCI Therapy, in Early Idiopathic Parkinson’s Disease Patients: The EPSILON Study | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson’s Disease Patients, with an Open-Label ExtensionThe EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone - EPSILON | Early Idiopathic 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: Ongentys Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: OPICAPONE | BIAL – Portela & Cª, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 324 | Phase 3 | Serbia;Portugal;Czechia;Spain;Ukraine;Turkey;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Bulgaria;Germany | ||
| 4 | EUCTR2020-005011-52-FR (EUCTR) | 23/06/2021 | 01/04/2021 | Efficacy and Safety of Opicapone, as an Add-on to Stable L-DOPA Plus DDCI Therapy, in Early Idiopathic Parkinson’s Disease Patients: The EPSILON Study | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson’s Disease Patients, with an Open-Label ExtensionThe EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone - EPSILON | Early Idiopathic 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: Ongentys Product Name: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: OPICAPONE | BIAL – Portela & Cª, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 324 | Phase 3 | Serbia;Portugal;Czechia;Spain;Ukraine;Turkey;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Bulgaria;Germany | ||
| 5 | NCT04978597 (ClinicalTrials.gov) | May 31, 2021 | 5/7/2021 | Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study) | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel-Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add-on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson's Disease Patients, With an Open-Label Extension | Parkinson | Drug: Opicapone 50 mg;Drug: Placebo | Bial - Portela C S.A. | NULL | Recruiting | 30 Years | 80 Years | All | 324 | Phase 3 | Bulgaria |
| 6 | EUCTR2020-005011-52-IT (EUCTR) | 28/05/2021 | 04/06/2021 | Efficacy and Safety of Opicapone, as an Add-on to Stable L-DOPA Plus DDCI Therapy, in Early Idiopathic Parkinson's Disease Patients: The EPSILON Study | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson's Disease Patients, with an Open- Label ExtensionThe EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone - EPSILON | Early Idiopathic 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: Ongentys Product Name: Opicapone Product Code: [BIA 9-1067] INN or Proposed INN: OPICAPONE | BIAL-Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 324 | Phase 3 | Serbia;Portugal;Czechia;Spain;Ukraine;Turkey;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Bulgaria;Germany | ||
| 7 | EUCTR2020-005011-52-BG (EUCTR) | 17/05/2021 | 22/03/2021 | Efficacy and Safety of Opicapone, as an Add-on to Stable L-DOPA Plus DDCI Therapy, in Early Idiopathic Parkinson’s Disease Patients: The EPSILON Study | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson’s Disease Patients, with an Open-Label ExtensionThe EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone - EPSILON | Early Idiopathic 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: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: OPICAPONE | BIAL – Portela & Cª, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 324 | Phase 3 | Serbia;Portugal;Czechia;Spain;Ukraine;Turkey;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Bulgaria;Germany | ||
| 8 | EUCTR2020-005011-52-CZ (EUCTR) | 12/05/2021 | 04/03/2021 | Efficacy and Safety of Opicapone, as an Add-on to Stable L-DOPA Plus DDCI Therapy, in Early Idiopathic Parkinson’s Disease Patients: The EPSILON Study | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson’s Disease Patients, with an Open-Label ExtensionThe EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone - EPSILON | Early Idiopathic 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: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: OPICAPONE | BIAL – Portela & Cª, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 324 | Phase 3 | Serbia;Portugal;Czechia;Spain;Ukraine;Turkey;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Bulgaria;Germany | ||
| 9 | EUCTR2010-021860-13-CZ (EUCTR) | 24/06/2011 | 09/11/2010 | 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 | 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 - BIPARK STUDY I | Adjunct to levodopa L-DOPA/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations. MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Trade Name: Comtan® Product Name: Over-encapsulated Entacapone Tablets Product Code: Over-encapsulated Entacapone Tablets INN or Proposed INN: ENTACAPONE Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: BIA 9-1067 Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina |