Status:
RECRUITING
Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)
Lead Sponsor:
Denali Therapeutics Inc.
Collaborating Sponsors:
Biogen
Conditions:
Parkinson Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief 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 effect...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06602193
Start Date
October 24 2024
End Date
February 28 2028
Last Update
November 28 2025
Active Locations (16)
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1
Cedars-Sinai Department of Neurology
Los Angeles, California, United States, 90048
2
University of California San Francisco
San Francisco, California, United States, 94158
3
Parkinson's Disease and Movement Disorders Center
Boca Raton, Florida, United States, 33486
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215