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Clinical Trial Details

Title
CSPC-NBP-2001: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Add-On to Standard-of-Care Study of n-Butylphthalide (NBP) Softgel Capsules for Treatment of Mild to Moderate Acute Ischemic Stroke in Adult Subjects
Study Description

The main purpose of this study is to learn the how safe is the study drug when it is added to your routine care. Other purposes of the study are to determine how the study drug is absorbed, distributed, broken down, and removed from the body, 2522and how well it works compared to placebo as measured by improvement of your disability, recovery of your stroke, and your physical function. A placebo is an inactive material that looks like the study drug but does not contain any active study drug. Researchers use a placebo to see if the study drug works better or is safer than not taking anything. .

The study is divided into 3 time periods: a screening/randomization period, a treatment period, and a follow up period. During each study period you will have 1 or more visits with your study doctor. Your screening visit, randomization, and first dose of the study drug might be on the same day, so you can receive the study medicine within the first 12 hours of the onset of your stroke. You will be given at least the first 2 days (4 doses) of study drug while you are hospitalized so that the study doctor can monitor your response. You will continue taking study medication every 12 hours for a total of 30 days after your stroke. You or your caregiver will be given instructions and study medication for the period, after you are discharged from the hospital. Your length of stay in the hospital will be determined by your health and routine care for your stroke. You will be asked to visit the study site on Days 252215, 30, and 90. You will be contacted via telephone on Days 8, 23, and 60 by the study staff. You will be followed up to Day 90. At each visit, you will spend almost 1-2 hours at the study site.

Investigators

Principal Investigator
Scott L. Silliman, M.D.
Neurology