BIA 28-6156 for Parkinson's Disease

(ACTIVATE Trial)

Recruiting in Palo Alto (17 mi)

+130 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Bial R&D Investments, S.A.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called BIA 28-6156 to see if it can slow down movement problems in people with Parkinson's disease who have a specific genetic mutation. The study will compare the drug to another treatment over a period of several months.

Research Team

Raquel Costa

Principal Investigator

Bial R&D Investments, S.A.

Eligibility Criteria

This trial is for adults aged 35-80 with Parkinson's disease (PD) diagnosed between 1 and 7 years, carrying a specific GBA1 gene variant but not Gaucher's disease. They must have mild to moderate PD severity, stable PD medication use, no severe motor issues or surgery plans that could affect the study, and agree to birth control if applicable. Excluded are those with atypical parkinsonism, substance abuse history, certain medical conditions or treatments that might interfere with the study.

Inclusion Criteria

I meet all the requirements for the genetic screening part of the study.

I am between 35 and 80 years old.

My Parkinson's disease is in the early or mid-stage.

Exclusion Criteria

I have Gaucher's disease, confirmed by symptoms or tests showing low GCase activity.

I have a form of parkinsonism that is not typical Parkinson's disease.

I have had or will have major surgery that could affect my participation in the study.

Treatment Details

Interventions

• BIA 28-6156 (Enzyme Inhibitor)
• Placebo (Drug)

Trial Overview The trial tests BIA 28-6156 (10 mg or 60 mg) against a placebo in delaying motor progression over 78 weeks in patients with GBA-PD. It's randomized and double-blind meaning neither participants nor researchers know who receives the drug or placebo during the study.

Participant Groups

Group I: BIA 28-6156 60 mg Experimental Treatment 1 Intervention

Participants will be randomized to receive BIA 28-6156 60 mg during the Treatment Period.

Group II: BIA 28-6156 10 mg Experimental Treatment 1 Intervention

Participants will be randomized to receive BIA 28-6156 10 mg during the Treatment Period.

Group III: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Bial R&D Investments, S.A.

Lead Sponsor

Trials

2

Recruited

240+