Parkinson's Disease MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Biogen Idec Research Limited
Eligibility
Sex/Gender
All
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 (=)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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Incidence of AEs and SAEs during the treatment period 2. Time to confirmed worsening in MDS-UPDRS Part II score over the treatment period 3. Change in MDS-UPDRS Parts II and III combined score 4. Time to confirmed worsening in Schwab and England Activities of Daily Living Scale (SEADL) over the treatment period 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 2. Up to Week 144 3. From Baseline to Week 48 4. Up to Week 144 5. From Baseline to Week 48 | — |
Countries
Austria, Canada, China, France, Germany, Israel, Italy, Japan, Netherlands, Poland, Spain, United Kingdom, United States
Outcome results
None listed