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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
US Biogen Clinical Trial Center
866-633-4636
clinicaltrials@biogen.com
Global Biogen Clinical Trial Center
clinicaltrials@biogen.com
Parkinson Disease
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
In this study, researchers will learn more about BIIB122 in participants with early-stage Parkinson's disease (PD). The study will include adults aged 30 to 80 who were diagnosed with PD within 2 years of starting the study.
The main objective of the study is to learn about the effect BIIB122 has on slowing down the worsening of PD symptoms. The main question researchers want to answer is:
- How long does it take for PD symptoms to worsen during BIIB122 treatment?
Researchers will answer this and other questions by measuring the symptoms of PD over time using a variety of scoring tools. These include the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and the modified Schwab and England Activities of Daily Living Scale (mSE-ADL).
The MDS-UPDRS is used to measure symptoms of PD. It has 4 parts: Part I, II, III, and IV. Each part measures different aspects of motor and non-motor symptoms. The mSE-ADL measures a participant's ability to perform daily activities or personal chores.
Researchers will also learn more about the safety of BIIB122. They will check participants for adverse events. Adverse events are unwanted health problems that may or may not be caused by the study drug.
The study will be done as follows:
* Participants will be randomly assigned to take either BIIBB122 or placebo. A placebo looks like the study drug but contains no real medicine.
* Neither the researchers nor the participants will know if the participants are receiving BIIB122 or placebo.
* Participants will take BIIB122 or placebo tablets by mouth once a day.
* The treatment period for each participant will last between 48 and 144 weeks.
* There will be a safety follow-up period for 2 weeks after the last dose of BIIB122.
* In total, participants will have up to 29 study visits.
* Participants will stay in the study for at least 1 year, up to about 3 years.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
This is in the inclusion criteria above
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Global Biogen Clinical Trial Center
clinicaltrials@biogen.com
US Biogen Clinical Trial Center
866-633-4636
clinicaltrials@biogen.com
The study is sponsored by Biogen and is in collaboration with Denali Therapeutics Inc..
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
