Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Opicapone

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    6 result(s) found for: Opicapone. Displaying page 1 of 1.
    EudraCT Number: 2020-001176-15 Sponsor Protocol Number: BIA-91067-405 Start Date*: 2021-05-07
    Sponsor Name:Bial - Portela & Ca, S.A.
    Full Title: 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.
    Medical condition: Parkinson's disease patients with wearing-off motor fluctuations and associated sleep disorders.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-002754-24 Sponsor Protocol Number: BIA-91067-403 Start Date*: 2021-07-06
    Sponsor Name:Bial - Portela & Ca, S.A.
    Full Title: 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 tre...
    Medical condition: Parkinson's Disease (PD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10034005 Parkinson's disease and parkinsonism HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Completed) PT (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005011-52 Sponsor Protocol Number: BIA-91067-303 Start Date*: 2021-05-12
    Sponsor Name:BIAL – Portela & Cª, S.A.
    Full Title: 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 ...
    Medical condition: Early Idiopathic Parkinson’s disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) BG (Completed) PT (Completed) FR (Completed) BE (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001175-32 Sponsor Protocol Number: BIA-91067-404 Start Date*: 2020-09-29
    Sponsor Name:Bial - Portela & Ca, S.A.
    Full Title: 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.
    Medical condition: Parkinson's disease patients with wearing-off motor fluctuations and associated pain.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) PT (Completed) IT (Completed) CZ (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-002391-27 Sponsor Protocol Number: BIA-OPC-401 Start Date*: 2016-10-07
    Sponsor Name:BIAL - Portela & Ca, S.A.
    Full Title: 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...
    Medical condition: Parkinson's disease (PD) patients with wearing-off motor fluctuations
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    20.0 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-021860-13 Sponsor Protocol Number: BIA-91067-301 Start Date*: 2010-11-11
    Sponsor Name:BIAL - Portela & Ca, S.A.
    Full Title: 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, RANDOMIS...
    Medical condition: Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10061536 Parkinson's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) LT (Completed) AT (Completed) LV (Completed) DE (Completed) ES (Completed) PT (Completed) CZ (Completed) SK (Completed) BG (Completed) RO (Completed) IT (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue May 06 07:08:01 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA