Trial ID or NCT#

NCT03318523

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 40 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Laurice Yang
Laurice Yang
Movement disorders specialist
Clinical Assistant Professor, Neurology & Neurological Sciences

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