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

Evaluating BIA 28-6156's effects and safety in GBA-PD patients.

Recruiting
35-80 years
All
Phase 2

This study tests a new drug, BIA 28-6156, for Parkinson's disease in people with a specific gene change called GBA-PD. Parkinson's disease is a brain disorder that affects movement. This study checks if the drug works and is safe. There are two main parts: genetic screening and treatment. First, they check if you have the GBA1 gene change. If yes, you might join the treatment part. You'll either get BIA 28-6156 (10 mg or 60 mg) or a placebo, which is a harmless pill that looks like the real drug, but has no effect. The study lasts for 78 weeks with a follow-up of 4 weeks to check safety. You will keep taking your usual Parkinson's medicine.

  • Must have Parkinson's for at least 1 year, but not more than 7 years.
  • Need to attend multiple visits over the 78 weeks.
  • No severe motor problems or major surgeries planned.

Consider joining if you meet the criteria and are okay with the study length.

Study details
    Parkinson's Disease

NCT05819359

Bial R&D Investments, S.A.

27 June 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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