Trial record 1 of 1 for:
2020-001175-32
OpiCapone Effect on Motor Fluctuations and pAiN (OCEAN)
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ClinicalTrials.gov Identifier: NCT04986982 |
Recruitment Status : Unknown
Verified July 2021 by Bial - Portela C S.A..
Recruitment status was: Recruiting
First Posted : August 3, 2021
Last Update Posted : August 3, 2021
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Sponsor:
Bial - Portela C S.A.
Information provided by (Responsible Party):
Bial - Portela C S.A.
Tracking Information | |||||
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First Submitted Date ICMJE | July 27, 2021 | ||||
First Posted Date ICMJE | August 3, 2021 | ||||
Last Update Posted Date | August 3, 2021 | ||||
Actual Study Start Date ICMJE | February 25, 2021 | ||||
Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change from baseline in Domain 3 (fluctuation-related pain) of King's Parkinson's Disease Pain Scale (KPPS) [ Time Frame: Up to 24 weeks ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | OpiCapone Effect on Motor Fluctuations and pAiN | ||||
Official Title ICMJE | 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. | ||||
Brief Summary | The aim of this study is to investigate the efficacy of 50 mg opicapone when administered with the existing treatment of levodopa (L-dopa) plus a dopa decarboxylase inhibitor (DDCI), in Parkinson's disease (PD) patients with end-of-dose motor fluctuations and associated pain | ||||
Detailed Description | This is a randomised, double-blind, placebo-controlled, multi-centre, parallel group, interventional clinical study in PD patients with end-of-dose motor fluctuations and associated pain. The study consists of a 1-week screening period, a 24-week double-blind treatment period and 2 weeks of follow-up period. The duration of treatment for the individual patient is expected to be up to 24 weeks. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Parkinson Disease | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
140 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2022 | ||||
Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 30 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04986982 | ||||
Other Study ID Numbers ICMJE | BIA-91067-404 2020-001175-32 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Bial - Portela C S.A. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Bial - Portela C S.A. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Bial - Portela C S.A. | ||||
Verification Date | July 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |