A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants with Early Parkinson’s Disease
This research study is looking into a new drug called BHV-8000 for people who have been recently diagnosed with Parkinson's disease. The main goal is to find out if BHV-8000 can help keep daily symptoms of Parkinson's from getting worse as quickly, compared to people taking a placebo (a dummy drug with no active ingredients). Researchers will track how people manage their daily activities over nearly a year using a special questionnaire. They will also check changes in movement symptoms, overall health as seen by a doctor, and brain scans to see how the disease might be progressing. The study aims to gather important information about how effective BHV-8000 might be.
At a glance
What is this study about?
This study is a clinical trial, which means it's a carefully planned research project to test a new medicine called BHV-8000. It's designed for people who are in the early stages of Parkinson's disease. The main question researchers want to answer is whether BHV-8000 can help to slow down the progression of symptoms that affect daily living, such as difficulties with dressing, eating, or walking.
To do this, some participants will receive BHV-8000, while others will receive a placebo. A placebo looks exactly like the real medicine but contains no active drug. Neither the participants nor their doctors will know who is getting which, to ensure the results are as fair and unbiased as possible. Over about 48 weeks (nearly a year), the study team will regularly check how participants are feeling and managing their daily activities.
They will use special questionnaires and medical exams to measure any changes. They will also use brain scans and ask doctors to give their opinion on the participants' overall health. All this information will help them understand if BHV-8000 is effective in managing early Parkinson's disease symptoms.
Key takeaways
- This study is testing a new drug, BHV-8000, for early Parkinson's disease.
- It aims to see if BHV-8000 can slow down daily symptom worsening.
- Participants will receive either BHV-8000 or a dummy drug (placebo).
- The study lasts for nearly one year and involves regular clinic visits and assessments.
- Brain scans and symptom checks will be used to track progress.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
Importantly, participants must have been diagnosed with Parkinson's disease, and it needs to be in its early stages. There will be other medical checks to make sure the study is a good fit for you.
- Are you 18 years old or older?
- Have you been diagnosed with early Parkinson's disease?
- Are you able to attend regular clinic visits?
- Are you willing to take a study medication daily?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you will be in the study for up to 48 weeks, which is about 11 months. You will have regular visits to the clinic where doctors and nurses will check your health and how you're feeling. During these visits, you'll answer questionnaires about your daily life and movement, and doctors will perform examinations to assess your symptoms.
You will be given either the study drug, BHV-8000, or a placebo to take regularly. You will also have a special type of scan called a DaT-SPECT scan, usually at the beginning and near the end of the study, which helps doctors look at certain brain cells. All these assessments help the researchers understand how the study drug is working.
Potential risks and benefits
Locations (10)
- —Germany
- —France
- —Italy
- —Belgium
- —Czechia
- —Poland
- —Austria
- —Netherlands
- —Spain
- —Portugal
Common questions
What is Parkinson's disease?
Parkinson's disease is a condition that affects the brain, causing problems with movement like shaking, stiffness, and balance.
What is a 'placebo'?
A placebo is a dummy pill or treatment that looks like the real medicine but doesn't contain any active drug. It helps researchers compare the new medicine fairly.
What is a DaT-SPECT scan?
It's a special type of brain scan that can help doctors see how certain brain cells involved in movement are working.
How long will I be in the study?
You would be in the study for up to 48 weeks, which is almost a year.
Will I know if I'm getting the real drug or the placebo?
No, neither you nor your doctor will know if you're taking BHV-8000 or the placebo until the study is over. This is called 'double-blind'.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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