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01
Overview
Phase 2, randomised, double-blind trial in Parkinson's disease (PD) comparing BIIB122 225 mg with Placebo (2 arms). Primary endpoint: Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale Parts II and III Combined Score at 144 weeks. Started Apr 2022; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
BIIB122 225 mg
BIIB122 225 mg tablets by mouth once daily
Placebo
Matching placebo tablets by mouth once daily
03
Who it enrols
Adults aged 30-80 with early-stage Parkinson's disease diagnosed within 2 years, Hoehn and Yahr stage 1-2, MDS-UPDRS II+III <= 50, and MoCA >= 24. Excludes atypical parkinsonism and other significant neurological disorders.
04
Endpoints
Primary
Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale Parts II and III Combined Score
Secondary
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Time to Confirmed Worsening in MDS-UPDRS Part II Score
Change From Baseline in MDS-UPDRS Parts II and III Combined Score
Time to Confirmed Worsening in Modified Schwab and England Activities of Daily Living Scale
Change From Baseline in MDS-UPDRS Parts I, II, and III Combined Score
05
Results
Not all primary endpoints met
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