BIA 28-6156 for Parkinson's Disease
(ACTIVATE Trial)
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
The trial requires that participants have been on stable doses of Parkinson's disease medications for at least 30 days (60 days for rasagiline) before starting the study. However, you cannot use certain medications like strong CYP3A4 inhibitors or inducers, BCRP substrates, or specific antipsychotics within 60 days before the trial.
What makes the drug BIA 28-6156 unique for Parkinson's disease?
BIA 28-6156 may be unique in its approach to treating Parkinson's disease by potentially targeting the glutamatergic system, which is different from traditional treatments that primarily focus on the dopaminergic system. This could help manage symptoms and complications like motor fluctuations by modulating glutamate activity.12345
Who Is on the Research Team?
Raquel Costa
Principal Investigator
Bial R&D Investments, S.A.
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Genetic Screening
Identify individuals with a PD risk-associated variant in the GBA1 gene for potential enrolment
Screening
Participants are screened for eligibility to participate in the trial
Double-Blind Treatment
Participants receive BIA 28-6156 or placebo to assess efficacy, safety, and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BIA 28-6156
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bial R&D Investments, S.A.
Lead Sponsor