Parkinson DiseaseNCT07522606
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
A study testing BIA 28-6156 in people with Parkinson Disease, run by Bial R&D Investments, S.A. at 36 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- BIA 28-6156
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 36 sitesin 5 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
36 sites in 5 countries.
36 sites in 5 countries
United States16 sites
University of Colorado
Aurora, Colorado, 80045
University of Maryland Medical Center
Baltimore, Maryland, 21201
Parkinson's Center and Movement Disorders of Boca Raton
Boca Raton, Florida, 33486
Massachusetts General Hospital
Boston, Massachusetts, 02114
MUSC
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Kansas Medical Center
Kansas City, Kansas, 66103
University of Kentucky
Lexington, Kentucky, 40536
University of Miami, Dept. of Neurology
Miami, Florida, 33136
Vanderbilt Medical Center
Nashville, Tennessee, 37232
Barrow Neurological Institute
Phoenix, Arizona, 85013
Park Nicollet Struther's Parkinson's Center (Struthers Parkinsons Center at HealthPartners)
Saint Paul, Minnesota, 55427
Intermountain Healthcare
Salt Lake City, Utah, 84107
University of Washington
Seattle, Washington, 98195
Inland Northwest Research
Spokane, Washington, 99202
Italy8 sites
IRCCS Istituto Delle Scienze Neurologiche DI
Bologna
Spedali Civilia di Brescia
Brescia, 25123
Ospedale Antonio Perrino
Brindisi, 72100
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122
Universita degli Studi della Campania Luigi Vanvitelli - Clinica Neurologia I
Naples, 80138
Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Neurologica
Padova, 35128
IRCSS San Raffaele Pisana
Roma, 163
A.O.U. San Giovanni di Dio Ruggi d'Aragona Centro Parkinson- Piano Rialzato Corpo QT
Salerno, 84125
Spain7 sites
Hospital Universitari Germans Trias i Pujol
Badalona, 08916
Hospital Universitario Cruces
Barakaldo, 48903
Hospital de la Santa Creu I Sant Pau
Barcelona, 08025
Hospital Vall D´Hebron
Barcelona, 08035
Hospital Universitaio de La Princesa
Madrid, 28006
Hospital Ruber Internacional
Madrid, 28034
Hospital Universitario Virgen del Rocio
Seville, 41013
United Kingdom4 sites
NHS Tayside-Ninewells Hospital and Medical School
Dundee
King's College London - David Goldberg Centre
London
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital
Newcastle upon Tyne
University Hospitals Plymouth NHS Trust
Plymouth
About this study
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.
Read the 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
- Being tested
- BIA 28-6156
- Keywords
- Parkinson's disease, Neurodegenerative Diseases, Central Nervous System Diseases, Parkinsonian Disorders, Movement Disorders, GBA1 gene, BIA 28-6156, ACTIVATE, Compassionate Use
- Medical subject headings
- Parkinson Disease, Neurodegenerative Diseases, Central Nervous System Diseases, Parkinsonian Disorders, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIA 28-6156Drug
60mg dosage of BIA 28-6156 taken orally once daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Bial R&D Investments, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522606
- Sponsor's protocol ID
- BIA 28-6156 CUP
- Status last verified
- Aug 2026
- First submitted
- 26 Mar 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07522606
- Acronym / sponsor ID
- BIA 28-6156 CUP
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Neurodegenerative Diseases, Central Nervous System Diseases, Parkinsonian Disorders, Movement Disorders, GBA1 gene, BIA 28-6156, ACTIVATE
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Bial R&D Investments, S.A.Industry (pharma, biotech, devices)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIA 28-615660mg dosage of BIA 28-6156 taken orally once daily | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIA 28-6156 in people with Parkinson Disease, run by Bial R&D Investments, S.A. at 36 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Italy, Spain, United Kingdom, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.