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

NCT05819359 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2026-05-13

No results posted yet for this study

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).

Conditions

Interventions

DRUG

BIA 28-6156 10 mg

BIA 28-6156 10 mg, once daily, oral administration.

DRUG

BIA 28-6156 60 mg

BIA 28-6156 60 mg, once daily, oral administration.

DRUG

Placebo

Placebo, once daily, oral administration.

Sponsors & Collaborators

  • Bial R&D Investments, S.A.

    lead INDUSTRY

Principal Investigators

  • Raquel Costa · Bial R&D Investments, S.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2026-04-02
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05819359 on ClinicalTrials.gov