This Phase 2a, multicenter, randomized, 12-week double-blind, placebo-controlled, parallel-group study, followed by an OLE, is designed to evaluate the safety, tolerability, and pharmacodynamic effects of BIIB122 in participants with LRRK2-PD. LRRK2-PD is defined as Parkinson's Disease (PD) in individuals who are heterozygous or homozygous carriers of a pathogenic LRRK2 variant that increases LRRK2 kinase activity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Cedars-Sinai Department of Neurology
Los Angeles, California, United States
RECRUITINGUniversity of California San Francisco
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) with BIIB122 compared with placebo over the 12-week double-blind period
Time frame: 12 weeks
Change from baseline in whole-blood pS935 LRRK2 with BIIB122 compared with placebo at Week 12
Time frame: 12 weeks
Change from baseline in urine BMP with BIIB122 compared with placebo at Week 12
Time frame: 12 weeks
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San Francisco, California, United States
Parkinson's Disease and Movement Disorders Center
Boca Raton, Florida, United States
RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGIchan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center
New York, New York, United States
RECRUITINGEvergreen Health Laboratory
Kirkland, Washington, United States
RECRUITINGInland Northwest Research
Spokane, Washington, United States
RECRUITINGTechnische Universität Dresden
Dresden, Germany
RECRUITINGUniversity of Lübeck
Lübeck, Germany
RECRUITINGUniversity Hospital Tübingen
Tübingen, Germany
RECRUITING...and 6 more locations