Acasti Announces Poster Detailing GTX-104 STRIVE-ON Trial
$ACST
Biotechnology: Pharmaceutical Preparations
Health Care
The poster, Safety and Tolerability of Intravenous Versus Enteral Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage, will be presented Thursday February 8th during the Ongoing Clinical Trials session of the conference.
The STRIVE-ON trial is a prospective, open-label, randomized (1:1 ratio), parallel group trial of GTX-104 compared with oral nimodipine, in patients hospitalized for aSAH. Key trial design features include:
- 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.