A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, With an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects With Parkinson's Disease
Who is this study for? Patients with Parkinson's disease
What treatments are being studied? BIIB054
Status: Terminated
Location: See all (75) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The primary objective of the study is 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. The secondary objectives of the study are 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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
• 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.
Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Arizona
St. Joseph's Hopsital & Medical Center- Barrow Neurological Institute
Phoenix
California
Research Site
La Jolla
Cedars Sinai
Los Angeles
University of California San Francisco Medical Center
San Francisco
Research Site
Stanford
Colorado
University of Colorado Health
Aurora
Rocky Mountain Movement Disorders Center, PC
Englewood
Florida
Parkinson's Disease and Movement Disorders Centerf
Boca Raton
Mayo Clinic Hospital
Jacksonville
Bioclinica Research
Orlando
USF Health Byrd Institute
Tampa
Illinois
Northwestern University PD and Movement Disorders Center
Chicago
Research Site
Chicago
Kansas
University of Kansas Medical Center Research Institute
Kansas City
Louisiana
Ochsner Health System
New Orleans
Massachusetts
Boston University Medical Center
Boston
Massachusetts General Hospital
Boston
Michigan
Quest Research Institute
Farmington Hills
North Carolina
Research Site
Durham
Wake Forest Baptist Health
Winston-salem
New York
NYU Langone Health Center
New York
Research Site
New York
Ohio
The Cleveland Clinic Foundation
Cleveland
Pennsylvania
Research Site
Philadelphia
University of Pittsburgh Medical Center Health System
Pittsburgh
South Carolina
Medical University of South Carolina
Charleston
Tennessee
Research Site
Nashville
Texas
Research Site
Houston
Washington
Booth Gardner Parkinson's Care Center at Evergreen Health
Kirkland
Inland Northwest Research
Spokane
Wisconsin
Medical College of Wisconsin
Milwaukee
Other Locations
Austria
Research Site
Innsbruck
Canada
Montreal Neurological Institute Clinical Research Unit
I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo
Pozzilli
IRCCS San Raffaele
Roma
Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
Salerno
Azienda Ospedaliera Santa Maria di Terni
Terni
Spain
Biocruces Health Research Institute
Barakaldo
Hospital Clinic De Barcalona
Barcelona
Hospital Santa Creu i Sant Pau
Barcelona
Research Site
Madrid
Research Site
Madrid
Research Site
Madrid
Research Site
Móstoles
Clinica Universidad de Navarra
Pamplona
Hospital General de Catalunya
Sant Cugat Del Vallés
Research Site
Sevilla
United Kingdom
Research Site
Cambridge
Research Site
London
Clinical Ageing Research Unit
Newcastle Upon Tyne
Research Site
Oxford
Salford Royal
Salford
Royal Hallamshire Hospital
Sheffield
Time Frame
Start Date:2018-01-10
Completion Date:2021-04-29
Participants
Target number of participants:357
Treatments
Placebo_comparator: Placebo
Year 1: Participants will receive matching placebo to BIIB054 on Day 1 and then every 4 weeks.~Year 2: Participants who received placebo in year 1 will be randomized into one of the active treatment arms in year 2 and will receive BIIB054 intravenous (IV) infusion on Week 52 and then every 4 weeks.
Experimental: BIIB054 250 mg
Participants will receive BIIB054 250 milligrams (mg) intravenous (IV) infusion on Day 1 and then every 4 weeks.
Experimental: BIIB054 1250 mg
Participants will receive BIIB054 1250 mg IV infusion on Day 1 and then every 4 weeks.
Experimental: BIIB054 3500 mg
Participants will receive BIIB054 3500 mg IV infusion on Day 1 and then every 4 weeks.