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RECRUITING
NCT06602193
PHASE2

Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)

Sponsor: Denali Therapeutics Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

BIIB122 225 mg

Administered as specified in the treatment arm

OTHER

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