46 completed, 1 active not recruiting. 32 Phase 1, 5 Phase 4, 4 Phase 3, 2 Phase 2, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 32 | Completed 32 |
| Phase 4 | 5 | Completed 5 |
| Phase 3 | 4 | Completed 4 |
| Phase 2 | 2 | Completed 2 |
| Not applicable | 1 | Completed 1 |
Follow opicapone: new trials by email Literature Review of opicapone trials Research Report on opicapone
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| REal-life ON PARKinson's - ITaly (REONPARK-IT) Opicapone 50 mg - Parkinson Disease | Active not recruiting | Bial - Portela C S.A. | 200 | 2025-07-08 | 2026-07-13 | |
| Opicapone as Adjunctive Therapy to Levodopa-Carbidopa Intestinal Gel in Parkinson's Disease Opicapone 50 mg, Duodopa - Parkinson Disease, Effect of Drug | Not applicable | Completed | University Hospital of Ferrara | 22 | 2022-07-01 | 2025-03-03 |
| eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs. Opicapone, L-DOPA/DDCI - Parkinson Disease | Phase 4 | Completed | Bial - Portela C S.A. | 106 | 2021-11-29 | 2025-03-12 |
| A Study to Evaluate the add-on Efficacy and Safety of Opicapone 50 mg or an Extra Dose of L-DOPA 100 mg for the Treatment of Wearing-off in Patients With PD Ongentys 50mg, Madopar Tab. 125 or Perkin Tab. 25-100mg - Parkinson Disease | Phase 4 | Completed | SK Chemicals Co., Ltd. | 169 | 2021-06-17 | 2023-06-01 |
| OpicApone Sleep dISorder Opicapone - Parkinson Disease | Phase 4 | Completed | Bial - Portela C S.A. | 22 | 2021-06-09 | 2025-03-12 |
| Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study) Opicapone 50 mg, Placebo - Parkinson | Phase 3 | Completed | Bial - Portela C S.A. | 410 | 2021-05-31 | 2025-03-12 |
| Opicapone Treatment Initiation Open-Label Study Opicapone - Parkinson Disease | Completed | Neurocrine Biosciences | 239 | 2021-03-01 | 2022-11-28 | |
| OpiCapone Effect on Motor Fluctuations and pAiN Opicapone 50 mg, Placebo - Parkinson Disease | Phase 4 | Completed | Bial - Portela C S.A. | 144 | 2021-02-25 | 2025-03-28 |
| Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's Disease Opicapone, Levodopa (L-DOPA) + Standard care - Parkinson Disease | Completed | Bial - Portela C S.A. | 39 | 2020-04-28 | 2021-10-04 | |
| Relative Bioavailability and Bioequivalence of Opicapone Ongentys, BIA 9-1067 (test) - Parkinson Disease | Phase 1 | Completed | Bial - Portela C S.A. | 45 | 2019-03-19 | 2020-12-31 |
| Bioavailability and Bioequivalence Between Two Active Pharmaceutical Ingredient (API) Sources of Opicapone (OPC) 50 mg BIA 9 1067, 25 mg BIA9 1067, 50 mg Ongentys - Parkinson Disease | Phase 1 | Completed | Bial - Portela C S.A. | 72 | 2018-02-20 | 2020-02-11 |
| A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa. Opicapone, Carbidopa Levodopa - Parkinson Disease | Phase 1 | Completed | Neurocrine Biosciences | 16 | 2018-02-08 | 2019-03-22 |
| Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone Opicapone (OPC) - Parkinson Disease | Phase 1 | Completed | Bial - Portela C S.A. | 56 | 2017-06-20 | 2018-10-15 |
| Efficacy and Safety of Opicapone in Clinical Practice BIA 9-1067, levodopa/dopa decarboxylase inhibitor - Parkinson's Disease With Wearing-off Motor Fluctuations | Phase 4 | Completed | Bial - Portela C S.A. | 518 | 2016-11-23 | 2018-10-15 |
| Effect of Food on Opicapone Opicapone (OPC) - Parkinson Disease | Phase 1 | Completed | Bial - Portela C S.A. | 28 | 2014-11-21 | 2017-04-17 |
| Effect of Opicapone at Steady State on Warfarin Pharmacokinetics BIA 9-1067, Warfarin - Parkinson's Disease | Phase 1 | Completed | Bial - Portela C S.A. | 20 | 2014-03-01 | 2014-12-02 |
| Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers BIA 9-1067, Paracetamol - Parkinson's Disease | Phase 1 | Completed | Bial - Portela C S.A. | 28 | 2014-03-01 | 2015-11-18 |
| Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers BIA 9-1067 (clinical micronized, CM), BIA 9-1067 (to-be-marketed, TBM) - Parkinson | Phase 1 | Completed | Bial - Portela C S.A. | 85 | 2014-03-01 | 2025-03-12 |
| Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone BIA 9-1067 non-micronized, BIA 9-1067 micronized - Parkinson Disease | Phase 1 | Completed | Bial - Portela C S.A. | 28 | 2014-02-01 | 2015-08-21 |
| Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation BIA 9-1067 - Epilepsy | Phase 1 | Completed | Bial - Portela C S.A. | 56 | 2014-02-01 | 2015-08-21 |
Showing 20 of 47. Sign in to see all of them.
Parkinson Disease (42) · Dyskinesias (1) · Epilepsy (1)
Bial - Portela C S.A. (42) · Neurocrine Biosciences (2) · Rabin Medical Center (1) · SK Chemicals Co., Ltd. (1) · University Hospital of Ferrara (1)
France (9) · Portugal (9) · Canada (6) · United Kingdom (5) · Germany (3) · Italy (3) · United States (3) · Romania (2) · Ukraine (2) · Bulgaria (1) · Israel (1) · Netherlands (1) · Russia (1) · South Korea (1) · Spain (1)
Eric Sicard, MD (3) · Joaquim Ferreira, MD, PhD (2) · Manuel Vaz-da-Silva, MD, PhD (2) · Dikran Mouradian, MD (1) · Giovanni Fabbrini (1) · Haejung Marr, MD (1) · Kallol Ray Chaudhuri, MD, DSc (1) · Mariachiara Sensi, MD-Phd (1) · Marie-Claude Homery, MD (1) · Nicolas Fauchoux, MD (1) · Olga Klepitskaya, MD, FAAN (1) · Patricio Soares-da-Silva, MD, PhD (1)
PMID 26725544, PMID 28027332, PMID 32345378, PMID 32597817, PMID 35313124, PMID 40979212
2008 (1), 2009 (1), 2016 (1)