drugset / Trial / NCT05819359

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

NCT05819359 ↗

Phase 2 Active not recruiting 237 enrolled Bial R&D Investments, S.A.
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2023-03-31
Primary completion
2026-04-02
Completion
2026-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject BIA 28-6156 Unknown 10 mg Oral
Subject BIA 28-6156 Unknown 60 mg Oral

Indications