Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study) (EPSILON)
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ClinicalTrials.gov Identifier: NCT04978597 |
Recruitment Status :
Active, not recruiting
First Posted : July 27, 2021
Last Update Posted : April 14, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | July 5, 2021 | ||||
First Posted Date ICMJE | July 27, 2021 | ||||
Last Update Posted Date | April 14, 2023 | ||||
Actual Study Start Date ICMJE | May 31, 2021 | ||||
Estimated Primary Completion Date | January 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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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 ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study) | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | Opicapone (OPC) is a third generation catechol O methyltransferase (COMT) inhibitor (COMTi) developed by BIAL-Portela & Cª, S.A. It is approved as adjunctive therapy to preparations of L-DOPA/DDCI in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations. Carbidopa and benserazide are both DDCIs used in association with L DOPA. When OPC is co administered with L DOPA/DDCI, peripheral COMT is inhibited and thus L DOPA plasma levels increase, increasing L DOPA bioavailability. The purpose of this Phase III study is to explore the potential of OPC to enhance the clinical benefit of L-DOPA in L DOPA treated patients in the early stages of Parkinson's Disease (PD) (patients without end-of-dose motor fluctuations, 'non fluctuators'). | ||||
Detailed Description | This is a Phase III study to evaluate the efficacy and safety of OPC in subjects with early idiopathic PD receiving treatment with L DOPA plus a DDCI, and who are without signs of any motor complication (consisting of fluctuations in the motor response and/or involuntary movements or dyskinesias). After a screening period of up to 4 weeks, eligible subjects will be randomized into 1 of 2 treatment arms (OPC 50 mg, or placebo) in a 1:1 ratio, and enter a 24-week placebo-controlled, parallel-group, double blind period. At the end of the double-blind period, subjects may enter an additional 1-year, open-label period, at the discretion of both the Investigator and subject, in which all subjects will be treated with OPC 50 mg. A Post-study Visit (PSV) will be performed approximately 2 weeks after the End of Study Visit (EOS) or Early Discontinuation Visit (EDV). Study treatment will be administered in combination with existing treatment of L-DOPA/DDCI. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
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 | ||||
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 |
410 | ||||
Original Estimated Enrollment ICMJE |
324 | ||||
Estimated Study Completion Date ICMJE | January 2024 | ||||
Estimated Primary Completion Date | January 2024 (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 to 80 Years (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 | Bulgaria | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04978597 | ||||
Other Study ID Numbers ICMJE | BIA-91067-303 2020-005011-52 ( 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 |