Parkinson's disease
Conditions
Interventions
Research Name: BIIB122 (also known as DNL151)
Generic Name: Not applicable
Trade Names: Not applicable
Participants will receive either BIIB122 225 mg or placebo QD orally for up to 144 weeks.
Sponsors
Matsuda Naoto
Eligibility
Sex/Gender
All
Inclusion criteria
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, 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.
Exclusion criteria
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. -MoCA score < 24 at the Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to confirmed worsening in 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 from Baseline to Week 48 -Time to confirmed worsening on SE-ADL over the treatment period -Change in MDS-UPDRS Parts I, II, and III combined score from Baseline to Week 48 | — |
Countries
Canada, China, Israel, Japan, United Kingdom, United States
Contacts
Public ContactBiogen Japan Medical Information
Biogen Japan Ltd.
Outcome results
None listed