A Study to Assess the Safety of BIIB122 Tablets and if it can Slow the Worsening of Early-Stage Parkinson’s Disease in Participants Between the Ages of 30 and 80

Phase 1

Conditions: Parkinson's Disease
MedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2021-004849-20-DE

Lead Sponsor: Biogen Idec Research Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 640

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. Confirmation of this eligibility requirement may come
from an accredited genetic test that includes all exclusionary LRRK2
genetic variants.

NOTE: Other protocol defined Inclusion criteria may apply. See Protocol
section 6.1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 416
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 224

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of BIIB122 225 mg compared with placebo.;Secondary Objective: To evaluate the efficacy, safety and tolerability and of BIIB122 225 mg compared with placebo;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: Minimum 48 weeks, maximum 144 weeks.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Incidence of AEs and SAEs during the treatment period<br>2. Time to confirmed worsening in MDS-UPDRS Part II score over the treatment period<br>3. Change in MDS-UPDRS Parts II and III combined score<br>4. Time to confirmed worsening in Schwab and England Activities of Daily Living Scale (SEADL) over the treatment period<br>5. Change in MDS-UPDRS Parts I, II, and III combined score;Timepoint(s) of evaluation of this end point: 1. Minimum 48 weeks, maximum 144 weeks<br>2. Up to Week 144<br>3. From Baseline to Week 48<br>4. Up to Week 144<br>5. From Baseline to Week 48<br>

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