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Free drug access for Parkinson's patients with specific gene mutation

NCT ID NCT07522606

Disease control Sponsor: Bial R&D Investments, S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended) This study
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This program offers continued free access to the experimental drug BIA 28-6156 for people with Parkinson's disease who have a specific change in the GBA1 gene and have already completed the ACTIVATE study. Participants take one 60mg pill daily. The goal is to provide ongoing treatment while more data is collected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BIA 28-6156 (a drug taken orally once daily)
What this could lead to
If it works, this could provide ongoing symptom control for people with a specific genetic form of Parkinson's disease.
What could go wrong
This is a small compassionate-use program, not a formal trial, so results may not apply broadly. The drug's long-term benefits and risks are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

central nervous system disorder GBA1-related Parkinson disease, susceptibility movement disorder neurodegenerative disease Parkinson disease parkinsonian disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson disease

Contacts and locations

Locations

  • A.O.U. San Giovanni di Dio Ruggi d'Aragona Centro Parkinson- Piano Rialzato Corpo QT

    Salerno, 84125, Italy

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Hospital Ruber Internacional

    Madrid, 28034, Spain

  • Hospital Senhora da Oliveira de Guimaraes

    Guimarães, 4835-044, Portugal

  • Hospital Universitaio de La Princesa

    Madrid, 28006, Spain

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916, Spain

  • Hospital Universitario Cruces

    Barakaldo, 48903, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital Vall D´Hebron

    Barcelona, 08035, Spain

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, 08025, Spain

  • IRCCS Istituto Delle Scienze Neurologiche DI

    Bologna, Italy

  • IRCSS San Raffaele Pisana

    Roma, 163, Italy

  • Inland Northwest Research

    Spokane, Washington, 99202, United States

  • Intermountain Healthcare

    Salt Lake City, Utah, 84107, United States

  • King's College London - David Goldberg Centre

    London, United Kingdom

  • MUSC

    Charleston, South Carolina, 29425, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • NHS Tayside-Ninewells Hospital and Medical School

    Dundee, United Kingdom

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ospedale Antonio Perrino

    Brindisi, 72100, Italy

  • Park Nicollet Struther's Parkinson's Center (Struthers Parkinsons Center at HealthPartners)

    Saint Paul, Minnesota, 55427, United States

  • Parkinson's Center and Movement Disorders of Boca Raton

    Boca Raton, Florida, 33486, United States

  • Spedali Civilia di Brescia

    Brescia, 25123, Italy

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital

    Newcastle upon Tyne, United Kingdom

  • Universita degli Studi della Campania Luigi Vanvitelli - Clinica Neurologia I

    Naples, 80138, Italy

  • Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Neurologica

    Padova, 35128, Italy

  • University Hospitals Plymouth NHS Trust

    Plymouth, United Kingdom

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66103, United States

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Miami, Dept. of Neurology

    Miami, Florida, 33136, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Vanderbilt Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

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