About aneurysmal subarachnoid hemorrhage (aSAH)

aSAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain. A primary cause of such bleeding is the rupture of an aneurysm. Approximately 70% of aSAH patients experience death or dependence, and more than 30% die within one month of hemorrhage. Approximately 50,000 patients in the United States are affected by aSAH per year, based on market research.

STRIVE-ON Phase 3 Trial

STRIVE-ON (NCT05995405) will study a parallel group of 100 patients hospitalized aSAH in a randomized (1:1 ratio) open-label comparison between oral nimodipine and intravenous (IV) GTX-104.

  • Approximately 100 patients are expected to be enrolled at an estimated 25 hospitals in the U.S.
  • The primary endpoint is safety and will be measured as comparative adverse events, including hypotension, between the two groups.
  • GTX-104 will be administered as a continuous IV infusion of 0.15 mg/hour, and a 30-minute IV bolus of 4 mg every 4 hours. Oral nimodipine will be administered as 60 mg (two 30 mg capsules) every 4 hours.
  • Both groups will receive their assigned GTX-104 or oral nimodipine for up to 21 consecutive days and will be evaluated from commencement of patient treatment through a 90-day follow-up period.

STRIVE-ON Phase 3 Trial Patient Enrollment Timeline

Flowchart showing STRIVE-ON Phase 3 Trial patient enrollment and trial timeline.