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n-Butylphthalide (NBP) Softgel Capsules in Stroke Patients

Title 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
Therapeutic Area Stroke
Principal Investigator David E. Thaler, MD, PhD
Min Age 18 Years
Max Age 80 Years
Gender All
Contact Sarah Gans
617-636-7606
More Information https://www.clinicaltrials.gov/ct2/show/NCT#02905565

Overview

The main purpose of this study is to learn the how safe the study drug, n-butylphthalide (NBP) is when 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, how well it works compared to placebo as measured by improvement of disability, recovery, and physical function after a stroke. Patients are randomized to either the study drug or a placebo and take pills twice daily for a month starting 12 hours from last-known well after stroke.

Study Details

Inclusion Criteria

  • A clinical diagnosis of mild to moderate cortical or subcortical AIS
  • Able to swallow the softgel capsules as assessed by a swallowing evaluation
  • Completes screening procedures such that study treatment is first administered within 12 hours of stroke onset. The stroke onset time will be defined as the last time when the individual did not experience current acute stroke symptoms

Exclusion Criteria

  • History of intracranial hemorrhage
  • Seizure at onset of stroke
  • Rapidly improving or resolving symptoms, suggesting a possible transient ischemic attack (TIA) rather than a qualifying stroke

Study Requirements

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 15 and 30. 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.