Colorado Springs Neurological Associates | Colorado Springs, CO
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).
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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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