Status:
TERMINATED
A Study to Assess if BIIB122 Tablets Are Safe and Can Slow Worsening of Early-Stage Parkinson's Disease in Participants With Specific LRRK2 Genetic Variants Between the Ages of 30 and 80 Using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale
Lead Sponsor:
Biogen
Collaborating Sponsors:
Denali Therapeutics Inc.
Conditions:
Parkinson Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE3
Brief Summary
In this study, researchers will learn more about a study drug called BIIB122 in participants with early-stage Parkinson's disease (PD). The study will focus on participants with a specific genetic var...
Detailed Description
BIIB122 is an investigational central nervous system-penetrant small molecule inhibitor of LRRK2 kinase
Eligibility Criteria
Inclusion
- Key
- Clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria within 5 years of the Screening Visit, inclusive, and at least 30 years of age at the time of diagnosis
- Modified Hoehn and Yahr scale (mHY), Stages 1 to 2.5 (in OFF state), inclusive, at Screening
- MDS-UPDRS Parts II and III (in OFF state) combined score ≤40 at Screening
- Screening genetic test results verifying the presence of a pathogenic leucine-rich repeat kinase 2 (LRRK2) variant
- Key
Exclusion
- Clinically significant neurologic disorder other than PD, including, but not limited to, stroke, dementia, or seizure within 5 years of Screening Visit, in the opinion of the Investigator
- Clinical evidence of atypical parkinsonism (e.g., multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
August 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05418673
Start Date
August 26 2022
End Date
July 27 2023
Last Update
June 26 2024
Active Locations (27)
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1
University of California San Francisco (UCSF)
San Francisco, California, United States, 94143
2
University of Colorado
Aurora, Colorado, United States, 80045
3
Rocky Mountain Movement Disorders Center, PC
Englewood, Colorado, United States, 80113
4
Parkinson's Disease and Movement Disorders Center
Boca Raton, Florida, United States, 33486