NCT07522606

Compassionate Use for BIA 28-6156 in Patients With Parkinson's Disease (PD) Who Have a Pathogenic Variant in the GBA1 Gene (GBA-PD) and Completed the ACTIVATE Study

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Bial R&D Investments, S.A. · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

This Program is designed to provide continued access BIA 28-6156, free and compassionately for an eligible patient previously enrolled in the BIA 28-6156-201 (ACTIVATE) clinical study and that had completed the study.

Detailed description

A patient taking part in this program will be provided with a 60mg dosage of BIA 28-6156. This will be taken orally once daily (OD) for the duration of the program, currently scheduled to run for 27 months. Patients will visit the site approximately every 3 months for a drug re-supply. At these visits, the treating physician will reassess if the patient should continue with the treatment. In case of tolerability concerns, the dose of BIA 28-6156 will be stopped per the treating physician's assessment. The treating physician should discontinue treatment for the patient and/or withdraw the patient from this program if he/she believes that continuation would be detrimental to the patient's well-being. Patients may voluntarily withdraw from treatment at any time, for any reason.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	BIA 28-6156	60mg dosage of BIA 28-6156 taken orally once daily

Timeline

• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

36 sites across 5 countries: United States, Italy, Portugal, Spain, United Kingdom