RecruitingPhase 2NCT06602193

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

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)


Sponsor

Denali Therapeutics Inc.

Enrollment

50 participants

Start Date

Oct 24, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and biological effects of a new drug called BIIB122 in people with Parkinson's disease who carry a mutation in the LRRK2 gene — a known genetic cause of Parkinson's. This drug aims to slow or modify how the disease progresses. **You may be eligible if...** - You are between 30 and 80 years old (or 30 or older if you carry two copies of the LRRK2 mutation) - You have been confirmed to carry a pathogenic (disease-causing) LRRK2 gene mutation through genetic testing - You have been clinically diagnosed with Parkinson's disease meeting standard diagnostic criteria **You may NOT be eligible if...** - You have another significant neurological disorder (such as stroke or dementia) in the past 5 years - You show signs of atypical parkinsonism (e.g., multiple system atrophy or progressive supranuclear palsy) - You have previously had brain surgery for Parkinson's (e.g., deep brain stimulation) - You have previously participated in the BIIB122 LUMA study or any gene therapy trial for Parkinson's - You have physical conditions that would interfere with motor assessments over time (such as severe arthritis or serious injuries) - You have abnormal vital signs or abnormal lung function test results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBIIB122 225 mg

Administered as specified in the treatment arm

OTHERBIIB122-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

View Full Details on ClinicalTrials.gov

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NCT06602193


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