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