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)
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: f
View:
• For heterozygous pathogenic LRRK2 mutation carriers: ≥ 30 to ≤ 80 years
• For homozygous pathogenic LRRK2 mutation carriers: ≥ 30 years
• Have screening genetic test results verifying the presence of a pathogenic LRRK2 variant.
• Have a clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria.
Locations
United States
California
Cedars-Sinai Department of Neurology
RECRUITING
Los Angeles
University of California San Francisco
RECRUITING
San Francisco
Florida
Parkinson's Disease and Movement Disorders Center
RECRUITING
Boca Raton
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
New York
Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center
RECRUITING
New York
Washington
Evergreen Health Laboratory
RECRUITING
Kirkland
Inland Northwest Research
RECRUITING
Spokane
Other Locations
Germany
Technische Universität Dresden
RECRUITING
Dresden
University of Lübeck
RECRUITING
Lübeck
University Hospital Tübingen
RECRUITING
Tübingen
Spain
Hospital Universitari General de Catalunya
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario Donostia
RECRUITING
Donostia / San Sebastian
Universitary Hospital La Princesa
RECRUITING
Madrid
IDIVAL/University Hospital Marques de Valdecilla
RECRUITING
Santander
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Contact Information
Primary
Clinical Trials at Denali Therapeutics
clinical-trials@dnli.com
Time Frame
Start Date: 2024-10-24
Estimated Completion Date: 2028-02-28
Participants
Target number of participants: 50
Treatments
Experimental: BIIB122 225 mg
Oral 225 mg dose, once daily (QD)
Placebo_comparator: BIIB122 Matching Placebo
Oral BIIB122 matching placebo, once daily (QD)
Related Therapeutic Areas
Sponsors
Leads: Denali Therapeutics Inc.
Collaborators: Biogen