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: -Diagnosed with Parkinson's disease (PD) within a maximum of 3 years prior to Screening. -Score of =2.5 on the Modified Hoehn and Yahr Scale. -Has not received any medication for the treatment of the motor symptoms of PD for at least 12 weeks prior to Day 1 and, in the opinion of the Investigator, is not expected to require PD treatment for at least 6 months following Day 1. Maximum total duration of prior PD regimens should not exceed 30 days. Stable (at least 8 weeks) dosages of medications that are used to treat conditions other than PD tremor are allowed. Further guidance will be provided by the study’s Medical Monitor on a case by case basis. -Screening dopamine transporter (DaT)/ single-photon emission computed tomography (SPECT) results consistent with neurodegenerative Parkinsonism (central reading). -All women of childbearing potential and all men must practice highly effective contraception during the study and for 6 months after their last dose of study treatment. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 203 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 154
Exclusion criteria
Exclusion criteria: - Presence of freezing of gait. - Montreal cognitive assessment (MOCA) score <23 or other significant cognitive impairment or clinical dementia that, in the opinion of the Investigator, would interfere with study evaluation. - History of or screening brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality, as read by central reader. - History of severe allergic or anaphylactic reactions, or history of hypersensitivity to BIIB054 or any of the inactive ingredients in the drug product or to radioligands or iodine used in the study. - Participation in any active immunotherapy study targeting alpha-synuclein. - Use of allowed medications not previously specified at doses that have not been stable for at least 8 weeks before Day 1, and/or that are not expected to remain stable for the duration of the study. - Clinically significant abnormal laboratory test values at Screening, as determined by the Investigator. - Blood donation (1 unit or more) within 8 weeks before Day 1 (must also refrain from donating blood for the duration of the study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - To evaluate the dose-related safety of BIIB054, -To evaluate the clinical efficacy of BIIB054 via MDS-UPDRS total score, -To assess the pharmacokinetic (PK) profile of BIIB054, -To evaluate the clinical efficacy of BIIB054 based on MDS-UPDRS subparts, -To evaluate the pharmacodynamic effects of BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals, and -To evaluate the immunogenicity of BIIB054. ;Main Objective: To evaluate the clinical efficacy of BIIB054 via dose response using the change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score.;Primary end point(s): Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I, II, and III) at Week 52 and Week 72) ;Timepoint(s) of evaluation of this end point: Baseline, Week 52, Week 72 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage of Participants With Adverse Event (AEs) and Serious Adverse Event (SAEs) - Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale MDS-UPDRS Total Score (Sum of Parts I, II, and III) at End of Study - Serum Concentration of BIIB054 - Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale MDS-UPDRS Subparts I, II and III at Week 52, Week 72 and End of Study - Change From Baseline in Striatal Binding Ratio (SBR) in Putamen, Striatum, and Caudate - Percentage of Participants With Anti-BIIB054 Antibodies in the Serum ;Timepoint(s) of evaluation of this end point: - Up to 178 weeks - Baseline, Week 178 - Baseline up to Week 144 - Baseline, Week 52, Week 72 and Week 178 - Baseline, Week 52 - Baseline up to Week 144 | — |
Countries
Austria, Canada, France, Germany, Israel, Italy, Spain, United Kingdom, United States
Contacts
Public ContactMedical Director
Biogen
Outcome results
None listed