Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD) (NCT06602193)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (9 items).
Location: Cedars-Sinai Department of Neurology — Los Angeles, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (20 Sites)
- 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,
- University of Lübeck — Lübeck,
- University Hospital Tübingen — Tübingen,
- Rabin Medical Center — Petah Tikva,
- Movement Disorders Institute, Sheba Medical Center — Ramat Gan,
- Tel Aviv Medical Center — Tel Aviv,
- Hospital Clinic de Barcelona — Barcelona,
- Hospital Universitari General de Catalunya — Barcelona,
- Hospital Universitari Vall d'Hebron — Barcelona,
- Hospital Universitario Donostia — Donostia / San Sebastian,
- Universitary Hospital La Princesa — Madrid,
- IDIVAL/University Hospital Marques de Valdecilla — Santander,
- Hospital Universitario Virgen del Rocio — Seville,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.