Trial record 1 of 1 for:
2020-002754-24
eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs. (ADOPTION)
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ClinicalTrials.gov Identifier: NCT04990284 |
Recruitment Status :
Active, not recruiting
First Posted : August 4, 2021
Last Update Posted : April 13, 2023
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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 4, 2021 | ||||
Last Update Posted Date | April 13, 2023 | ||||
Actual Study Start Date ICMJE | November 29, 2021 | ||||
Estimated Primary Completion Date | June 30, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
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 | eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs. | ||||
Official Title ICMJE | 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. | ||||
Brief Summary | This is a randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study in Parkinson's disease (PD) patients to evaluate the add-on efficacy of opicapone 50 mg or an extra dose of levodopa (L-DOPA) 100 mg as first strategy for the treatment of wearing-off. | ||||
Detailed Description | The study consists of a one-week screening period, four weeks of open-label treatment and two weeks of post-study follow-up. The total study duration for each patient will be approximately 7 weeks | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) 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 | Active, not recruiting | ||||
Actual Enrollment ICMJE |
106 | ||||
Original Estimated Enrollment ICMJE |
100 | ||||
Estimated Study Completion Date ICMJE | June 30, 2023 | ||||
Estimated Primary Completion Date | June 30, 2023 (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 | Germany, Italy, Portugal, Spain, United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04990284 | ||||
Other Study ID Numbers ICMJE | BIA-91067-403 2020-002754-24 ( 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 | April 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |