OPICAPONE ( DrugBank: Opicapone )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 6 | パーキンソン病 | 35 |
6. パーキンソン病
臨床試験数 : 2,298 / 薬物数 : 2,202 - (DrugBank : 350) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 202
| 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 | NCT04990284 (ClinicalTrials.gov) | November 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 | Not yet recruiting | 30 Years | N/A | All | 100 | Phase 4 | NULL |
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | NCT04821687 (ClinicalTrials.gov) | June 17, 2021 | 25/3/2021 | 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 | A Randomized, Parallel Group, Multicenter, Prospective, Open-label, Exploratory, Phase 4 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: Ongentys 50mg;Drug: Madopar Tab. 125 or Perkin Tab. 25-100mg | SK Chemicals Co., Ltd. | NULL | Recruiting | 30 Years | N/A | All | 200 | Phase 4 | Korea, Republic of |
| 9 | NCT04986995 (ClinicalTrials.gov) | June 9, 2021 | 27/7/2021 | OpicApone Sleep dISorder | Open-label, Single-arm, Pilot Study to Evaluate the Effect of Opicapone 50 mg on Parkinson's Disease Patients With End-of-dose Motor Fluctuations and Associated Sleep Disorders | Parkinson Disease | Drug: Opicapone | Bial - Portela C S.A. | NULL | Recruiting | 30 Years | N/A | All | 30 | Phase 4 | Portugal |
| 10 | 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 |
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | EUCTR2020-001176-15-DE (EUCTR) | 07/05/2021 | 17/12/2020 | Clinical study to investigate if Opicapone 50mg can reduce sleep disorders associated to Parkinson's disease. | Open-label, single-arm, pilot study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated sleep disorders. - OpicApone Sleep dISorder (OASIS) | Parkinson's disease patients with wearing-off motor fluctuations and associated sleep disorders. 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 50 mg hard capsules 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 | 30 | Phase 4 | Portugal;Germany | ||
| 15 | EUCTR2020-001176-15-PT (EUCTR) | 19/03/2021 | 04/01/2021 | Clinical study to investigate if Opicapone 50mg can reduce sleep disorders associated to Parkinson's disease. | Open-label, single-arm, pilot study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated sleep disorders. - OpicApone Sleep dISorder (OASIS) | Parkinson's disease patients with wearing-off motor fluctuations and associated sleep disorders. 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 50 mg hard capsules 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 | 30 | Phase 4 | Portugal;Germany | ||
| 16 | NCT04787965 (ClinicalTrials.gov) | March 1, 2021 | 4/3/2021 | Opicapone Treatment Initiation Open-Label Study | Opicapone Treatment Initiation Open-Label Study | Parkinson Disease | Drug: Opicapone | Neurocrine Biosciences | NULL | Recruiting | 18 Years | N/A | All | 250 | United States | |
| 17 | NCT04986982 (ClinicalTrials.gov) | February 25, 2021 | 27/7/2021 | OpiCapone Effect on Motor Fluctuations and pAiN | 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. | Parkinson Disease | Drug: Opicapone 50 mg;Other: Matching placebo | Bial - Portela C S.A. | NULL | Recruiting | 30 Years | N/A | All | 140 | Phase 4 | United Kingdom |
| 18 | EUCTR2020-001175-32-PT (EUCTR) | 15/01/2021 | 30/09/2020 | Clinical study to investigate if Opicapone 50mg can reduce 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 and associated 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: Opicapone 50 mg hard capsules 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;United Kingdom;Italy | ||
| 19 | EUCTR2020-001175-32-IT (EUCTR) | 17/12/2020 | 15/06/2021 | Clinical study to investigate if Opicapone 50mg can reduce pain associated to Parkinson's disease | Randomized, 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 and associated 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 50 mg capsule rigide 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 | 176 | Phase 4 | Portugal;Spain;Germany;United Kingdom;Italy | ||
| 20 | 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 | ||
| 21 | NCT03959540 (ClinicalTrials.gov) | April 28, 2020 | 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 | Completed | 75 Years | N/A | All | 39 | United Kingdom | |
| 22 | 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 |
| 23 | 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 |
| 24 | 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 |
| 25 | 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 |
| 26 | 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 |
| 27 | 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] | Trade Name: Ongentys Product Name: Ongentys | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Germany;United Kingdom | ||
| 28 | 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 | Trade Name: Ongentys Product Name: Ongentys | BIAL - Portela & Ca, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Germany;United Kingdom | ||
| 29 | 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 |
| 30 | 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 |
| 31 | 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 |
| 32 | 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 |
| 33 | 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 |
| 34 | 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 |
| 35 | 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 |