NCT03318523

Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Placebo	Administered as specified in the treatment arm
DRUG	BIIB054	Administered as specified in the treatment arm.

Timeline

• Start date: 2018-01-10
• Primary completion: 2020-10-26
• Completion: 2021-04-29
• First posted: 2017-10-24
• Last updated: 2022-02-28
• Results posted: 2021-11-23

Locations

75 sites across 9 countries: United States, Austria, Canada, France, Germany, Israel, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study