Clinical Trial

Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in GBA-PD

Study acronym: ACTIVATE
Active, Not Recruiting Phase 2
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Summary
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).
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2023-04-18; most recent amendment 2026-05-12.
Status change: Recruiting → Active, Not Recruiting 2024-08-20
Trial Details
NCT Number NCT05819359
Lead Sponsor Bial R&D Investments, S.A.
Conditions Parkinson's Disease
Enrollment 237 participants
Start Date 2023-03-31
Primary Completion 2026-04-02 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-13