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

Parkinson's Disease Clinical Trial

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in Subjects With Parkinson's Disease With a Pathogenic Variant in the Glucocerebrosidase (GBA1) Gene

Status Recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

• NCT number: NCT05819359
• Study type: Interventional
• Source: Bial R&D Investments, S.A.
• Contact: Raquel Costa
• Phone: 00351229866100
• Email: raquel.costa@bial.com
• Status: Recruiting
• Phase: Phase 2
• Start date: March 31, 2023
• Completion date: July 31, 2026