283PD201 (LUMA): A Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of BIIB122 in participants with Parkinson’s Disease
This study, called LUMA, is researching a new medicine for people with Parkinson's disease, named BIIB122. We’re aiming to find out if this new drug can help to slow down how quickly Parkinson’s affects people’s movement and their ability to do everyday tasks. To do this, some participants will receive the active medication, BIIB122, while others will receive a 'dummy pill' (placebo) that looks the same but contains no active drug. This helps us to see if any improvements are genuinely from the new medicine. We'll be closely monitoring everyone's progress to understand how safe BIIB122 is and how well it works. This is an important step in trying to find better treatments for Parkinson's disease.
At a glance
What is this study about?
This research study, known as LUMA, is focused on finding new ways to help people living with Parkinson's disease. Parkinson's is a condition that affects the brain and can cause problems with movement, balance, and daily activities. We are testing a new medicine called BIIB122 to see if it can slow down these changes.
Our main goal is to measure how long it takes for someone's Parkinson's symptoms to worsen, specifically focusing on movement and everyday tasks. We'll be comparing those who take BIIB122 with those who take a placebo, which is a pill that looks identical but contains no active medicine. This comparison is very important because it helps us truly understand if BIIB122 is having a real effect, rather than changes that might happen anyway or from simply taking a pill.
We will also be looking closely at how safe BIIB122 is by monitoring any side effects. Additionally, we’ll check how it affects other aspects of daily life and overall Parkinson's symptoms. This study is an important step in developing new and more effective treatments to help people manage their Parkinson's disease.
Key takeaways
- This study tests a new medicine, BIIB122, for Parkinson's disease.
- It aims to see if BIIB122 can slow down Parkinson's effects on movement and daily life.
- Some participants will get the new medicine, others a dummy pill (placebo).
- We will closely monitor your health and any side effects.
- Participation involves regular clinic visits for checks and assessments.
- This is an early-stage study to understand effectiveness and safety.
Who may be eligible?
To join this study, you must be 18 years old or older. There is no upper age limit. Both men and women are welcome to take part.
Beyond these basic requirements, the study team will need to do a more detailed check to make sure the study is a good fit for you. This will involve looking at your medical history and current health carefully. This is to ensure your safety and that the study results are as clear as possible.
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.
- Are you 18 years old or older?
- Do you have a confirmed diagnosis of Parkinson's disease?
- Are you willing to attend regular clinic visits and follow study instructions?
- Are you comfortable potentially receiving a placebo (dummy pill)?
What does participation involve?
If you decide to take part in this study, you would be assigned to either receive the new medication, BIIB122, or a matching dummy pill (placebo). Neither you nor your study doctor will know which one you are receiving – this is called a 'double-blind' study and helps ensure fair results.
You would need to attend regular visits to the study clinic over a period of time. During these visits, doctors and nurses would perform various checks. This includes physical examinations, asking questions about your symptoms and how you're feeling, and potentially some tests like blood tests. You would also be asked to keep track of any changes in your health or any side effects you experience.
The medication will be provided to you, and you will receive instructions on how and when to take it. There will be continuous follow-up to monitor your health and progress throughout the study duration. The exact number of visits and the total length of your participation would be explained in full detail by the study team.
Potential risks and benefits
Locations (7)
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedAustria
- —UnverifiedSpain
- —UnverifiedNetherlands
- —UnverifiedItaly
- —UnverifiedPoland
Common questions
What is a 'dummy pill' (placebo)?
A dummy pill, or placebo, looks exactly like the study drug but contains no active medicine. We use it to compare the new drug's effects against, to see if any changes are truly due to the medicine.
Will I know if I'm getting the new medicine or the dummy pill?
No, during the study, neither you nor your study doctor will know whether you are receiving BIIB122 or the dummy pill. This is done to keep the study fair and unbiased.
What does 'Phase II' mean for a study?
Phase II means this is an early stage of research. We're testing the safety of the new medicine and getting a better idea of how well it might work and what dose could be best.
What kind of tests will I have during the study?
You'll have regular checks of your movement and daily activities, similar to what your doctor already does. There might also be physical exams and potentially blood tests to monitor your health.
Can I stop participating in the study at any time?
Yes, absolutely. You are free to withdraw from the study at any point, for any reason, and it will not affect your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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