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Clinical trial

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

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Last updated:10th Jan 2018
Identifier: NCT03318523

To evaluate the dose-related safety of BIIB054, to evaluate the pharmacodynamic effects of BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals, to assess the pharmacokinetic (PK) profile of BIIB054 and to evaluate the immunogenicity of BIIB054.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 311 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, With an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects With Parkinson's Disease
Actual Study Start Date: January 10, 2018
Estimated Primary Completion Date: March 4, 2021
Estimated Study Completion Date: April 6, 2022

Arms:
- Placebo Comparator:
Placebo
- Experimental: BIIB054 250 mg
- Experimental: BIIB054 1250 mg
- Experimental: BIIB054 3500 mg

Category Value
Date last updated at source 2019-05-29
Study type(s) Interventional
Expected enrolment 311
Study start date 2018-01-10
Estimated primary completion date 2021-03-04

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