Status:
ACTIVE_NOT_RECRUITING
A Study to Learn About the Safety of BIIB122 Tablets and Whether They Can Slow the Worsening of Early-Stage Parkinson's Disease in Adults Between the Ages of 30 and 80
Lead Sponsor:
Biogen
Collaborating Sponsors:
Denali Therapeutics Inc.
Conditions:
Parkinson Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE2
Brief Summary
In this study, researchers will learn more about BIIB122 in participants with early-stage Parkinson's disease (PD). The study will include adults aged 30 to 80 who were diagnosed with PD within 2 year...
Detailed Description
BIIB122 is an investigational central nervous system-penetrant small molecule inhibitor of leucine-rich repeat kinase 2 (LRRK2). Participants who completed the early termination (ET) visit of the stud...
Eligibility Criteria
Inclusion
- Key
- Clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria within 2 years of the Screening Visit, inclusive, and at least 30 years of age at the time of diagnosis
- Modified Hoehn and Yahr scale stages 1 to 2 (in OFF state), inclusive, at screening
- MDS-UPDRS Parts II and III (in OFF state) combined score less than or equal to (≤)50 at screening
- Key
Exclusion
- Clinically significant neurological 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.
- Montreal Cognitive Assessment (MoCA) score \<24 at the screening visit.
- NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2026
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT05348785
Start Date
April 19 2022
End Date
March 9 2026
Last Update
October 23 2025
Active Locations (113)
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1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
2
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
3
University of Southern California
Los Angeles, California, United States, 90033
4
Cedars Sinai
Los Angeles, California, United States, 90048