A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants with Parkinson*s Disease

Phase 2

Conditions: paralysis agitans
primary parkinsonism
10028037

Registration Number: NL-OMON51537

Lead Sponsor: Biogen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 13

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 (<=)40 at screening
• Screening genetic test results verifying the absence of a pathogenic
leucine-rich repeat kinase 2 (LRRK2) variant (i.e., G2019S, N1437H, R1441G,
R1441C, R1441H, Y1699C, or I2020T). Participants with additional LRRK2 variants
may be excluded if data emerge to convincingly support an association of the
variants with LRRK2-PD pathogenicity.

NOTE: Other protocol defined Inclusion criteria may apply. See Protocol section
6.1.

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 <24 at the screening visit

NOTE: Other protocol defined Exclusion criteria may apply. See Protocol section
6.2

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Time to confirmed worsening in Movement Disorder Society Unified Parkinson*s<br /><br>Disease Rating Scale (MDS-UPDRS) Parts II and III combined score over the<br /><br>treatment period.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Incidence of AEs and SAEs during the treatment period<br /><br>• Time to confirmed worsening in MDS-UPDRS Part II score over the treatment<br /><br>period<br /><br>• Change in MDS-UPDRS Parts II and III combined score<br /><br>• Time to confirmed worsening in Schwab and England Activities of Daily Living<br /><br>Scale (SEADL) over the treatment period<br /><br>• Change in MDS-UPDRS Parts I, II, and III combined score</p><br>