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Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)
Sponsor: Denali Therapeutics Inc.
Summary
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.
Official title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)
Key Details
Gender
All
Age Range
30 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-10-24
Completion Date
2028-02-28
Last Updated
2026-02-18
Healthy Volunteers
No
Conditions
Interventions
BIIB122 225 mg
Administered as specified in the treatment arm
BIIB122-Matching Placebo
Administered as specified in the treatment arm
Locations (20)
Cedars-Sinai Department of Neurology
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Parkinson's Disease and Movement Disorders Center
Boca Raton, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center
New York, New York, United States
Evergreen Health Laboratory
Kirkland, Washington, United States
Inland Northwest Research
Spokane, Washington, United States
Technische Universität Dresden
Dresden, Germany
University of Lübeck
Lübeck, Germany
University Hospital Tübingen
Tübingen, Germany
Rabin Medical Center
Petah Tikva, Israel
Movement Disorders Institute, Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Medical Center
Tel Aviv, Israel
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitari General de Catalunya
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Spain
Universitary Hospital La Princesa
Madrid, Spain
IDIVAL/University Hospital Marques de Valdecilla
Santander, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain