Opicapone (DrugBank: Opicapone)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 6 | Parkinson disease | 16 |
| 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 | EUCTR2020-001175-32-GB (EUCTR) | 29/09/2020 | 07/08/2020 | Clinical study to evaluate the effect of opicapone 50 mg in the pain associated to Parkinson’s disease. | Randomised, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated pain. - OpiCapone Effect on motor fluctuations and pAiN (OCEAN) | Parkinson's disease patients with wearing-off motor fluctuations andassociated pain. 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: Ongentys INN or Proposed INN: Opicapone | Bial - Portela & Ca, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 176 | Phase 4 | Portugal;Spain;Germany;Italy;United Kingdom | ||
| 2 | NCT03959540 (ClinicalTrials.gov) | September 2019 | 23/4/2019 | Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease | A Multinational, Multicentre, Prospective Non-interventional Study to Assess Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease | Parkinson Disease | Drug: Opicapone;Drug: Levodopa (L-DOPA) + Standard care | Bial - Portela C S.A. | NULL | Not yet recruiting | 75 Years | N/A | All | 100 | NULL | |
| 3 | NCT03820037 (ClinicalTrials.gov) | March 2019 | 25/1/2019 | Relative Bioavailability and Bioequivalence of Opicapone | A Phase I, Open-Label, Randomised, Three-Period, Three-Sequence, Partial Replicate Crossover Study to Investigate the Relative Bioavailability and Bioequivalence of Opicapone Obtained From Two Different Sources, Under Fasting Conditions After Single-dose Administration in Healthy Subjects | Parkinson Disease | Drug: Ongentys;Drug: BIA 9-1067 (test) | Bial - Portela C S.A. | NULL | Not yet recruiting | 18 Years | 55 Years | All | 45 | Phase 1 | United Kingdom |
| 4 | NCT04265027 (ClinicalTrials.gov) | February 20, 2018 | 7/2/2020 | Bioavailability and Bioequivalence Between Two Active Pharmaceutical Ingredient (API) Sources of Opicapone (OPC) | An Open Label, Randomised, Two Period, Crossover Study to Assess Bioavailability, Bioequivalence and S COMT Activity Between Two Active Pharmaceutical Ingredient Sources of Opicapone at Two Different Dosage Strengths (50 mg and 25 mg) After Single and Multiple Dose Administrations Under Fasting Conditions in Healthy Volunteers. | Parkinson Disease | Drug: 50 mg BIA 9 1067;Drug: 25 mg BIA9 1067;Drug: 50 mg Ongentys;Drug: 25 mg Ongentys | Bial - Portela C S.A. | NULL | Completed | 18 Years | 55 Years | All | 72 | Phase 1 | United Kingdom |
| 5 | 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 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT03116295 (ClinicalTrials.gov) | June 20, 2017 | 12/4/2017 | Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone | A Comparative, Randomized, Open-label, Fasted, Single-dose, 2-way Crossover Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone in Healthy Subjects | Parkinson Disease | Drug: Opicapone (OPC) | Bial - Portela C S.A. | NULL | Completed | 18 Years | 55 Years | All | 56 | Phase 1 | Germany |
| 7 | NCT02847442 (ClinicalTrials.gov) | November 23, 2016 | 21/7/2016 | Efficacy and Safety of Opicapone in Clinical Practice | Efficacy and Safety of Opicapone in Clinical Practice in Parkinson's Disease Patients With Wearing-off Motor Fluctuations | Parkinson's Disease With Wearing-off Motor Fluctuations | Drug: BIA 9-1067;Drug: levodopa/dopa decarboxylase inhibitor | Bial - Portela C S.A. | NULL | Completed | 30 Years | N/A | All | 518 | Phase 4 | Germany |
| 8 | EUCTR2016-002391-27-GB (EUCTR) | 07/10/2016 | 04/08/2016 | Opicapone in clinical practice (OPTIPARK) | This action will amend the information submitted in this data field for all relevant applications. Please refer to the guidance under the Amendment tab and consider whether further notification to review bodies is required. - Opicapone in clinical practice (OPTIPARK)_V1 | Parkinson's disease (PD) patients with wearing-off motor fluctuations MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 4 | Germany;United Kingdom | |||
| 9 | EUCTR2016-002391-27-DE (EUCTR) | 05/10/2016 | 05/08/2016 | OPTIPARK | Efficacy and safety of opicapone in clinical practice in Parkinson’s Disease patients with wearing-off motor fluctuations | Parkinson's disease (PD) patients with wearing-off motor fluctuations;Therapeutic area: Not possible to specify | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 4 | Germany;United Kingdom | |||
| 10 | JPRN-JapicCTI-153112 | 22/1/2016 | 25/12/2015 | ONO-2370 Phase 2 study(ONO-2370-02) | ONO-2370 a Phase 2 Double-Blind, Randomised, Placebo-Controlled, Parallel-Group study, and an Open-Label, Uncontrolled, Multicenter, Long-term, Extension study(ONO-2370-02) | Parkinson's disease | Intervention name : ONO-2370 INN of the intervention : Opicapone Dosage And administration of the intervention : ONO-2370 once-daily Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Once-daily placebo equivalent to active control | ONO PHARMACEUTICAL CO.,LTD. | NULL | complete | 30 | 83 | BOTH | 399 | Phase 2 | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT03116308 (ClinicalTrials.gov) | November 21, 2014 | 12/4/2017 | Effect of Food on Opicapone | Effect of Food on Opicapone Bioavailability and Pharmacodynamics in Healthy Subjects | Parkinson Disease | Drug: Opicapone (OPC) | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 28 | Phase 1 | NULL |
| 12 | NCT02305017 (ClinicalTrials.gov) | March 2014 | 28/11/2014 | Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers | Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers | Parkinson's Disease | Drug: BIA 9-1067;Drug: Paracetamol | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 28 | Phase 1 | NULL |
| 13 | NCT02305030 (ClinicalTrials.gov) | March 2014 | 28/11/2014 | Effect of Opicapone at Steady State on Warfarin Pharmacokinetics | Effect of Opicapone at Steady State on Warfarin Pharmacokinetics in Healthy Volunteers | Parkinson's Disease | Drug: BIA 9-1067;Drug: Warfarin | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Both | 20 | Phase 1 | NULL |
| 14 | NCT02305316 (ClinicalTrials.gov) | February 2014 | 28/11/2014 | Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone | Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone in Healthy Volunteers | Parkinson Disease | Drug: BIA 9-1067 non-micronized;Drug: BIA 9-1067 micronized | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 28 | Phase 1 | NULL |
| 15 | NCT01851850 (ClinicalTrials.gov) | May 2013 | 1/5/2013 | Continuation Treatment Protocol for Patient Who Participated in the BIA 9-1067-302 Clinical Trial | Continue Providing Care for Patient Who Participated in the BIA 9-1067-302 Clinical Trial | Parkinson Disease | Drug: Opicapone | Rabin Medical Center | NULL | Completed | 30 Years | 80 Years | All | 1 | Phase 3 | Israel |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | EUCTR2010-021860-13-DE (EUCTR) | 09/03/2011 | 18/10/2010 | 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: 18.0;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: 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: Opicapone Product Code: BIA 9-1067 INN or Proposed INN: BIA 9-1067 Other descriptive name: BIA 9-1067 Product Name: Opicapone 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 |