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

Available (expanded access)

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID

NCT07522606

Run by

Bial R&D Investments, S.A.

Last updated by the study team

2026-04-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A patient who completes Part B (Double Blind Treatment arm) of the ACTIVATE study supplied by BIAL R\&D Investments, S.A., and falls within one week of completing the safety follow up visit from the ACTIVATE study.
• A patient is willing to provide written informed consent prior to initiating treatment, in accordance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. A patient who, in the opinion of the treating physician will likely adhere to the program.
• A patient's treating physician believes the patient could benefit from treatment with BIA 28-6156.
• Patient has received approval from Supplier or its designee following the treating physician request submission.
• If a sexually active man or a woman of childbearing potential, the patient agrees to use highly effective birth control or to remain abstinent during the program and for 30 days after the last dose of BIA 28-6156. Acceptable (highly effective) methods of contraception for this study include hormonal contraceptives (combined oral contraceptive, patch, vaginal ring, injectable, or implant); intrauterine device or system; complete abstinence from sexual intercourse if this is the patient's usual and preferred lifestyle; or sexual partner with surgical sterilization (e.g., tubal ligation, hysterectomy and/or bilateral oophorectomy.

You may not qualify if…

• A patient that has previously discontinued for any reason from the BIA 28-6156-201 clinical study.
• A patient who is pregnant, may be pregnant, lactating, or planning to be pregnant.

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• University of Colorado — Aurora, Colorado, United States
• Parkinson's Center and Movement Disorders of Boca Raton — Boca Raton, Florida, United States
• University of Miami, Dept. of Neurology — Miami, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Park Nicollet Struther's Parkinson's Center (Struthers Parkinsons Center at HealthPartners) — Saint Paul, Minnesota, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• MUSC — Charleston, South Carolina, United States
• Vanderbilt Medical Center — Nashville, Tennessee, United States
• Intermountain Healthcare — Salt Lake City, Utah, United States
• University of Washington — Seattle, Washington, United States
• Inland Northwest Research — Spokane, Washington, United States
• IRCCS Istituto Delle Scienze Neurologiche DI — Bologna, Italy
• Spedali Civilia di Brescia — Brescia, Italy
• Ospedale Antonio Perrino — Brindisi, Italy
• Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico — Milan, Italy
• Universita degli Studi della Campania Luigi Vanvitelli - Clinica Neurologia I — Naples, Italy
• Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Neurologica — Padova, Italy
• IRCSS San Raffaele Pisana — Roma, Italy
• A.O.U. San Giovanni di Dio Ruggi d'Aragona Centro Parkinson- Piano Rialzato Corpo QT — Salerno, Italy
• Hospital Senhora da Oliveira de Guimaraes — Guimarães, Portugal

Full record on ClinicalTrials.gov

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