---
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"
nct_id: NCT07522606
overall_status: AVAILABLE
sponsor: Bial R&D Investments, S.A.
study_type: EXPANDED_ACCESS
primary_condition: Parkinson Disease
countries: United States, Italy, Portugal, Spain, United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07522606.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07522606"
ct_last_update_post_date: 2026-04-13
last_seen_at: "2026-05-12T06:40:31.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT07522606](https://clinicaltrials.gov/study/NCT07522606)

## Key Facts

- **Status:** AVAILABLE
- **Study Type:** EXPANDED_ACCESS
- **Lead Sponsor:** Bial R&D Investments, S.A.
- **Conditions:** Parkinson Disease
- **CT.gov Last Update:** 2026-04-13

## Brief 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.

## Eligibility

- **Sex:** ALL

```
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.
```

## Interventions

- **BIA 28-6156** (DRUG) — 60mg dosage of BIA 28-6156 taken orally once daily

## Locations (36)

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.barrow neurological institute|phoenix|arizona|united states` — added _(2026-05-12)_
- `locations.university of colorado|aurora|colorado|united states` — added _(2026-05-12)_
- `locations.parkinson's center and movement disorders of boca raton|boca raton|florida|united states` — added _(2026-05-12)_
- `locations.university of miami, dept. of neurology|miami|florida|united states` — added _(2026-05-12)_
- `locations.northwestern university|chicago|illinois|united states` — added _(2026-05-12)_
- `locations.university of kansas medical center|kansas city|kansas|united states` — added _(2026-05-12)_
- `locations.university of kentucky|lexington|kentucky|united states` — added _(2026-05-12)_
- `locations.university of maryland medical center|baltimore|maryland|united states` — added _(2026-05-12)_
- `locations.massachusetts general hospital|boston|massachusetts|united states` — added _(2026-05-12)_
- `locations.park nicollet struther's parkinson's center (struthers parkinsons center at healthpartners)|saint paul|minnesota|united states` — added _(2026-05-12)_
- `locations.cleveland clinic foundation|cleveland|ohio|united states` — added _(2026-05-12)_
- `locations.musc|charleston|south carolina|united states` — added _(2026-05-12)_
- `locations.vanderbilt medical center|nashville|tennessee|united states` — added _(2026-05-12)_
- `locations.intermountain healthcare|salt lake city|utah|united states` — added _(2026-05-12)_
- `locations.university of washington|seattle|washington|united states` — added _(2026-05-12)_
- `locations.inland northwest research|spokane|washington|united states` — added _(2026-05-12)_
- `locations.irccs istituto delle scienze neurologiche di|bologna||italy` — added _(2026-05-12)_
- `locations.spedali civilia di brescia|brescia||italy` — added _(2026-05-12)_
- `locations.ospedale antonio perrino|brindisi||italy` — added _(2026-05-12)_
- `locations.fondazione irccs ca granda ospedale maggiore policlinico|milan||italy` — added _(2026-05-12)_
- `locations.universita degli studi della campania luigi vanvitelli - clinica neurologia i|naples||italy` — added _(2026-05-12)_
- `locations.universita degli studi di padova - azienda ospedaliera di padova - clinica neurologica|padova||italy` — added _(2026-05-12)_
- `locations.ircss san raffaele pisana|roma||italy` — added _(2026-05-12)_
- `locations.a.o.u. san giovanni di dio ruggi d'aragona centro parkinson- piano rialzato corpo qt|salerno||italy` — added _(2026-05-12)_
- `locations.hospital senhora da oliveira de guimaraes|guimarães||portugal` — added _(2026-05-12)_
- `locations.hospital universitari germans trias i pujol|badalona||spain` — added _(2026-05-12)_
- `locations.hospital universitario cruces|barakaldo||spain` — added _(2026-05-12)_
- `locations.hospital de la santa creu i sant pau|barcelona||spain` — added _(2026-05-12)_
- `locations.hospital vall d´hebron|barcelona||spain` — added _(2026-05-12)_
- `locations.hospital universitaio de la princesa|madrid||spain` — added _(2026-05-12)_
- `locations.hospital ruber internacional|madrid||spain` — added _(2026-05-12)_
- `locations.hospital universitario virgen del rocio|seville||spain` — added _(2026-05-12)_
- `locations.nhs tayside-ninewells hospital and medical school|dundee||united kingdom` — added _(2026-05-12)_
- `locations.king's college london - david goldberg centre|london||united kingdom` — added _(2026-05-12)_
- `locations.the newcastle upon tyne hospitals nhs foundation trust, freeman hospital|newcastle upon tyne||united kingdom` — added _(2026-05-12)_
- `locations.university hospitals plymouth nhs trust|plymouth||united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07522606.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07522606*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*