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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

This special programme is designed for individuals with Parkinson's disease linked to a specific change in their GBA1 gene. It allows continued access to a medicine called BIA 28-6156 for those who have already finished taking part in an earlier study (called ACTIVATE). The aim is to provide this treatment compassionately and free of charge. Participants will take a 60mg dose once daily and attend regular check-ups every three months for drug resupply. Doctors will review if the treatment should continue and patients can stop at any time. This programme is for those who might benefit and have met specific criteria from the previous study.

At a glance

Status

Available

Sponsor

Bial R&D Investments, S.A.

Parkinson Disease

What is this study about?

This programme offers continued access to a study drug called BIA 28-6156 for people living with Parkinson's disease. Specifically, it's for those whose Parkinson's is linked to a particular genetic change in the GBA1 gene, who have also successfully completed an earlier clinical trial of this drug, known as the ACTIVATE study.

Often, when a clinical trial ends, participants no longer have access to the experimental medicine. This 'compassionate use' programme aims to bridge that gap, allowing eligible individuals who experienced potential benefits in the previous study to continue receiving BIA 28-6156. It essentially provides a way for people to keep taking a medicine that might be helping them, while more research or regulatory reviews are still underway.

The programme ensures that this potential treatment remains available to those who qualify, free of charge, acknowledging the serious nature of Parkinson's disease and the desire to continue care for patients who have already invested their time in research. It’s important to remember this is still an investigational medicine, meaning it's not yet widely available or fully approved.

Key takeaways

This programme offers continued access to BIA 28-6156 for eligible Parkinson's patients.
It's for those who have completed the previous ACTIVATE study and have a specific genetic link (GBA1 gene).
The medicine is provided free of charge on compassionate grounds.
You'll take a daily dose and have regular check-ups every three months.
Your doctor will monitor your health, and you can stop participating at any time.
This is for continued treatment, not a new study participation.

Who may be eligible?

To be considered for this programme, you must have successfully completed the previous ACTIVATE study involving BIA 28-6156. This means you finished both parts of that study, including the follow-up safety checks, and applied to this programme shortly after.

Your doctor must believe that continuing to take BIA 28-6156 would be beneficial for you, and you need to be willing to follow the programme rules, including attending regular appointments. Formal approval from the drug's supplier is also required.

If you are a man or woman who could have children, you must agree to use reliable birth control or avoid sexual activity during the programme and for 30 days afterwards. If you stopped the original ACTIVATE study for any reason, or if you are pregnant, planning to become pregnant, or breastfeeding, you would not be able to join this programme.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Did you complete the entire ACTIVATE study for BIA 28-6156?
Does your doctor believe this treatment is good for you?
Are you able to attend regular clinic visits (about every 3 months)?
If you could have children, are you willing to use reliable birth control (or abstain) during the programme and for 30 days after stopping?
Are you NOT pregnant, planning pregnancy, or breastfeeding?
Did you NOT stop the original ACTIVATE study early for any reason?

Answer every question to see your result.

What does participation involve?

If you join this programme, you will receive a 60mg dose of BIA 28-6156, which you will take once daily by mouth. The programme is currently planned to last for about 27 months.

You will need to visit the clinic or your doctor about every three months to pick up more medicine. During these visits, your doctor will check on your health and decide if it's still beneficial and safe for you to continue with the treatment.

If you experience any concerning side effects or issues, your doctor may decide to stop the treatment. Your doctor can also withdraw you from the programme if they believe it's no longer in your best interest. You are completely free to withdraw from the programme yourself at any time, for any reason you choose.

Potential risks and benefits

The potential benefit of this programme is the continued access to BIA 28-6156, which may be helping to manage your Parkinson's symptoms if you found it beneficial in the previous ACTIVATE study. As with any medicine, there are potential risks, including side effects, which your doctor will monitor closely. Your doctor will regularly assess your safety and well-being, and you can stop participating in the programme at any time, for any reason.

Locations (36)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Barrow Neurological Institute
Verified postcode
Phoenix, United States· Available
University of Colorado
Verified postcode
Aurora, United States· Available
Parkinson's Center and Movement Disorders of Boca Raton
Verified postcode
Boca Raton, United States· Available
University of Miami, Dept. of Neurology
Verified postcode
Miami, United States· Available
Northwestern University
Verified postcode
Chicago, United States· Available
University of Kansas Medical Center
Verified postcode
Kansas City, United States· Available
University of Kentucky
Verified postcode
Lexington, United States· Available
University of Maryland Medical Center
Verified postcode
Baltimore, United States· Available
Massachusetts General Hospital
Verified postcode
Boston, United States· Available
Park Nicollet Struther's Parkinson's Center (Struthers Parkinsons Center at HealthPartners)
Verified postcode
Saint Paul, United States· Available
Cleveland Clinic Foundation
Verified postcode
Cleveland, United States· Available
MUSC
Verified postcode
Charleston, United States· Available

Common questions

What is BIA 28-6156?

BIA 28-6156 is a medicine being studied for Parkinson's disease, specifically for people with a genetic link (GBA1 gene).

Why is this programme called 'compassionate use'?

It's called compassionate use because it allows eligible patients continued access to a study drug after a trial has ended, usually because the drug may be helping them and more time is needed for development or approval.

How long will I take the medicine?

The programme is currently planned to last for about 27 months, during which you will take the medicine once a day, as long as it's safe and beneficial.

Do I have to pay for the medicine?

No, the medicine is provided free of charge through this compassionate use programme.

Can I stop taking the medicine whenever I want?

Yes, you can choose to stop your treatment and leave the programme at any time, for any reason.

How to find out more

Raquel Costa

raquel.costa@bial.com 00351229866100 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.