Nimodipine in poor-grade aneurysm patients

Completed

Phase N/A Results

Trial Description

To study the effects of nimodipine in poor-grade aneurysm patients.

Interventions

  • Nimodipine (NimotopĀ®)Drug
    Intervention Desc: Calcium channel blocker (L-type calcium channels)

Trial Design

Randomized, placebo-controlled, double-blind study of 188 patients at 17 Canadian hospitals.

Patient Involvement

Patients were randomly assigned to receive 90 mg of nimodipine orally or placebo every 4 hours. All patients were required to have repeat angiogram on the 8th day following SAH and were also required to have repeat CT scan at 3-month assessment. Detailed neurological assessment was performed upon admission and at day 21 and at 3 months.

Outcomes

Type Measure Time Frame Safety Issue
Primary Reduction of poor outcomes (as determined by Glasgow Outcome Scale) due to the development of delayed ischemic deficits from vasospasm alone, reduction in incidence of severe diffuse or moderate diffuse vasospasm based on angiogram obtained on day 8, comparison of incidence and size of hypodense areas on 3-month CT scan, mortality.

Sponsors

Miles Pharmaceuticals, West Haven, Connecticut.