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

April 8, 2026 updated by: Bial R&D Investments, S.A.
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.

Study Overview

Status

Available

Conditions

Intervention / Treatment

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.

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy
        • Available
        • IRCCS Istituto Delle Scienze Neurologiche DI
      • Brescia, Italy, 25123
        • Available
        • Spedali Civilia di Brescia
      • Brindisi, Italy, 72100
        • Available
        • Ospedale Antonio Perrino
      • Milan, Italy, 20122
        • Available
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Naples, Italy, 80138
        • Available
        • Universita degli Studi della Campania Luigi Vanvitelli - Clinica Neurologia I
      • Padova, Italy, 35128
        • Available
        • Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Neurologica
      • Roma, Italy, 163
        • Available
        • IRCSS San Raffaele Pisana
      • Salerno, Italy, 84125
        • Available
        • A.O.U. San Giovanni di Dio Ruggi d'Aragona Centro Parkinson- Piano Rialzato Corpo QT
  • Portugal
      • Guimarães, Portugal, 4835-044
        • Available
        • Hospital Senhora da Oliveira de Guimaraes
  • Spain
      • Badalona, Spain, 08916
        • Available
        • Hospital Universitari Germans Trias i Pujol
      • Barakaldo, Spain, 48903
        • Available
        • Hospital Universitario Cruces
      • Barcelona, Spain, 08025
        • Available
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain, 08035
        • Available
        • Hospital Vall D´Hebron
      • Madrid, Spain, 28034
        • Available
        • Hospital Ruber Internacional
      • Madrid, Spain, 28006
        • Available
        • Hospital Universitaio de La Princesa
      • Seville, Spain, 41013
        • Available
        • Hospital Universitario Virgen del Rocio
  • United Kingdom
      • Dundee, United Kingdom
        • Available
        • NHS Tayside-Ninewells Hospital and Medical School
      • London, United Kingdom
        • Available
        • King's College London - David Goldberg Centre
      • Newcastle upon Tyne, United Kingdom
        • Available
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital
      • Plymouth, United Kingdom
        • Available
        • University Hospitals Plymouth NHS Trust
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Available
        • Barrow Neurological Institute
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Available
        • University of Colorado
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Available
        • Parkinson's Center and Movement Disorders of Boca Raton
      • Miami, Florida, United States, 33136
        • Available
        • University of Miami, Dept. of Neurology
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Available
        • Northwestern University
    • Kansas
      • Kansas City, Kansas, United States, 66103
        • Available
        • University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Available
        • University of Kentucky
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Available
        • University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Available
        • Massachusetts General Hospital
    • Minnesota
      • Saint Paul, Minnesota, United States, 55427
        • Available
        • Park Nicollet Struther's Parkinson's Center (Struthers Parkinsons Center at HealthPartners)
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Available
        • Cleveland Clinic Foundation
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Available
        • MUSC
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Available
        • Vanderbilt Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Available
        • Intermountain Healthcare
    • Washington
      • Seattle, Washington, United States, 98195
        • Available
        • University of Washington
      • Spokane, Washington, United States, 99202
        • Available
        • Inland Northwest Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  1. 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.
  2. 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.
  3. A patient's treating physician believes the patient could benefit from treatment with BIA 28-6156.
  4. Patient has received approval from Supplier or its designee following the treating physician request submission.
  5. 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bial R&D Investments, S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIA 28-6156 CUP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on BIA 28-6156

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe