Controlled trial of nimodipine in subarachnoid hemorrhage

Completed

Phase N/A Results

Trial Description

To determine whether treatment with nimodipine would prevent or reduce the severity of ischemic neurologic deficits from arterial spasm.

Interventions

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

Trial Design

Prospective, double-blind, randomized, stratified, placebo-controlled trial of 125 patients at 5 centers. Patients stratified by center and treating physician.

Patient Involvement

Patients were randomized to receive a gelatin capsule containing either nimodipine or placebo. When patients could not take the capsules orally, the liquid within the capsules was delivered by nasogastric tube. The initial dose was 0.7 mg/ kg. Subsequent doses were 0.35 mg/kg every four hours for 21 days. Amount of blood in basal subarachnoid spaces on CAT scan prior to entry was measured.

Outcomes

Type Measure Time Frame Safety Issue
Primary Persistent and severe neurological deficit caused by cerebral arterial spasm at the end of 21-day treatment period.
Secondary Severity of spasm as determined by angiogram performed within 48 hours of onset of neurologic deficit.

Sponsors

Miles Pharmaceuticals.