paralysis agitans primary parkinsonism
Conditions
Interventions
Eligible participants will be randomly assigned in a 1:1 ratio to receive
BIIB122 225 mg or matching placebo tablets orally QD during the double-blind,
placebo-controlled treatment period.
Sponsors
Biogen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Key Inclusion Criteria: • 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 • MDS-UPDRS Parts II and III (in OFF state) combined score less than or equal to (
Exclusion criteria
Exclusion criteria: Key Exclusion Criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to confirmed worsening in Movement Disorder Society Unified Parkinson*s Disease Rating Scale (MDS-UPDRS) Parts II and III combined score over the treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Incidence of AEs and SAEs during the treatment period • Time to confirmed worsening in MDS-UPDRS Part II score over the treatment period • Change in MDS-UPDRS Parts II and III combined score • Time to confirmed worsening in Schwab and England Activities of Daily Living Scale (SEADL) over the treatment period • Change in MDS-UPDRS Parts I, II, and III combined score | — |
Countries
Netherlands
Outcome results
None listed