Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)
Condition(s) studied
Investigational drug(s) / intervention(s)
BIIB122 225 mg: Administered as specified in the treatment arm
BIIB122-Matching Placebo: Administered as specified in the treatment arm
Study 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
Primary outcome measure(s)
- Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) with BIIB122 compared with placebo over the 12-week double-blind period — 12 weeks
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| Cedars-Sinai Department of Neurology | Los Angeles | California | |
| University of California San Francisco | San Francisco | California | |
| Parkinson's Disease and Movement Disorders Center | Boca Raton | Florida | |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | |
| Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center | New York | New York | |
| Evergreen Health Laboratory | Kirkland | Washington | |
| Inland Northwest Research | Spokane | Washington | |
| 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 |
More Denali Therapeutics Inc. trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06602193 on ClinicalTrials.gov ↗ ← All trials in Spain