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Clinical Trials in the USA / NCT06602193
Active, not recruiting Phase 2

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

NCT06602193 · tracked via the Priya Life Science USA tracker
Sponsor
Denali Therapeutics Inc.
Phase
Phase 2
Started
2024-10-24
Last updated
2026-05-27

Condition(s) studied

Parkinson Disease

Investigational drug(s) / intervention(s)

BIIB122 225 mgBIIB122-Matching Placebo

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

Sex
ALL
Min age
30 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Have a history of any clinically significant neurological disorder other than PD, including, but not limited to, stroke and dementia, in the opinion of the investigator, within 5 years of the screening visit. * Have clinical evidence of atypical parkinsonism (eg, multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism. * Have previously participated or are currently participating in the BIIB122 LUMA study (Study 283PD201). * Have previously participated or are currently participating in a gene therapy study for PD. * Have a history of brain surgical intervention for PD (eg, deep-brain stimulation, pallidotomy). * Have any physical condition that may confound the motor assessment (MDS-UPDRS) over time (eg, severe arthritis, severe dyskinesias, traumatic injuries with permanent physical disability). * Abnormal vitals including Blood Pressure, Heart Rate, or Body Temperature * Have abnormal PFT results at screening Note: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
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 the USA

Other trials for the same condition

Official registry record

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 the USA