Status and phase
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About
This is a randomized, double-blind study of PIPE-307 or placebo in subjects with relapsing-remitting multiple sclerosis. Subjects will be randomized into 1 of 3 separate cohorts (1:1:1 randomization ratio, PIPE-307 Dose A:PIPE-307 Dose B: Placebo) for a total duration of approximately 30 weeks.
Full description
This is a randomized, double-blind study of PIPE-307 or placebo given to 168 subjects randomized into one of 3 separate cohorts. They will be randomized 1:1:1 (PIPE-307 Dose A:Pipe 307 Dose B: Placebo). There will be a 28-day screening period followed by a 26-week treatment period. Safety will be assessed by periodic measurements of vital signs (VS), physical (PE) and neurological examinations, electrocardiograms (ECG), blood laboratory analyses and occurrence of adverse events (AE).
Enrollment
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Inclusion criteria
If enrolled in the visual evoked potential (VEP) sub-study, an additional inclusion criterion includes:
Exclusion criteria
If enrolled in the visual evoked potential (VEP) sub-study, an additional exclusion criterion includes:
Primary purpose
Allocation
Interventional model
Masking
168 participants in 3 patient groups, including a placebo group
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Central trial contact
Nancy Maack; Jules Lee
Data sourced from clinicaltrials.gov
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