BIAL
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About
The purpose of this randomized, double-blind, placebo-controlled study is to assess the efficacy of BIA 28-6156 over placebo in delaying clinical meaningful motor progression over 78 weeks in subjects with Parkinson's disease who have a pathogenic variant in the glucocerebrosidase 1 (GBA1) gene (GBA-PD).
Full description
This is a 2-part (Part A [Genetic Screening] and Part B [Double-Blind Treatment]), Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics of 2 fixed dose levels of BIA 28-6156 (10 and 60 mg/day) in approximately 237 subjects with genetically confirmed GBA-PD.
Part A (Genetic Screening) will identify individuals with a PD risk-associated variant in the GBA1 gene for potential enrolment into Part B (Double-Blind Treatment) of the study. Part B will consist of a screening period to ensure that all protocol inclusion/exclusion criteria for Part B of the study are met (up to 5 weeks). After screening period, eligible subjects will be randomized into 1 of 3 treatment arms (BIA 28-6156 10 mg/day, BIA 28-6156 60 mg/day, or placebo) in a 1:1:1 ratio, and enter a double-blind treatment period up to 78 weeks, followed by a 30-day (4 weeks) of safety follow-up period.
Subjects must be receiving a stable dose of PD medication for at least 30 days before screening (for Part B [Double-Blind Treatment]) and will continue to receive their usual PD medications throughout the study.
Enrollment
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Inclusion criteria
Subjects who satisfy all of the following criteria will be eligible for Part A (Genetic Screening) of the study:
Subjects who satisfy all the following criteria will be eligible for Part B (Double-Blind Treatment) of the study:
Exclusion criteria
• Individuals who do not satisfy the inclusion criteria for Part A (Genetic Screening) will be excluded.
Subjects who meet any of the following criteria for Part B (Double-Blind Treatment) are not eligible for the study.
Primary purpose
Allocation
Interventional model
Masking
237 participants in 3 patient groups, including a placebo group
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Central trial contact
Raquel Costa; Miguel M Fonseca, PhD
Data sourced from clinicaltrials.gov
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