Phase 2b Study of BIIB122 in Participants with Parkinson's Disease
- Conditions
- Parkinson's disease
- Registration Number
- JPRN-jRCT2031220519
- Lead Sponsor
- Tsuda Hiroshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 640
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 <= 40 at Screening.
-Screening genetic test results verifying the absence of a pathogenic LRRK2 variant. Confirmation of this eligibility requirement may come from an accredited genetic test that includes all exclusionary LRRK2 genetic variants.
-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.
-MoCA score < 24 at the Screening Visit.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to confirmed worsening in MDS-UPDRS Parts II and III combined score over the treatment period
- Secondary Outcome Measures
Name Time Method -Incidence of AEs and SAEs during the treatment period<br><br>-Time to confirmed worsening in MDS-UPDRS Part II score over the treatment period<br><br>-Change in MDS-UPDRS Parts II and III combined score from Baseline to Week 48<br><br>-Time to confirmed worsening on SE-ADL over the treatment period<br><br>-Change in MDS-UPDRS Parts I, II, and III combined score from Baseline to Week 48
Related Research Topics
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