A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants With Parkinson's Disease
A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants With Parkinson's Disease
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:
BIIB122 is an investigational central nervous system-penetrant small molecule inhibitor of leucine-rich repeat kinase 2 (LRRK2). Participants who completed the early termination (ET) visit of the study 283PD302 (NCT05418673) would be eligible for screening of this study and if enrolled, these participants are not eligible for the sub studies of 283PD201.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Boca Raton, Florida 33486, United States
Kansas City, Kansas 66160, United States
Loire-Atlantique, Loire-Atlantique 44093, France
Bron, Rhone 69500, France
Diego, Centonze 86077, Italy
Catania, 95123, Italy
Haeburu, Okinawa 901-1105, Japan
Asahikawa-shi, 070-8644, Japan
Himeji-shi, 672-8043, Japan
Santanda, Santanda 38003, Spain