Flunarizine in Stroke Treatment "FIST"

Completed

Phase N/A Results

Trial Description

To determine the effect of a large dose of flunarizine in the treatment of acute ischemic stroke in the territory of the middle cerebral artery.

Interventions

  • Flunarizine (Sibelium┬«)Drug
    Intervention Desc: Ion channel blocker (calcium channels)

Trial Design

International, multicenter, double-blind, placebo-controlled trial with two parallel groups involving 331 patients.

Patient Involvement

According to a random schedule, the patients were assigned to a 4-week double-blind treatment with either flunarizine (n = 166) or placebo (n = 165), one week intravenous administration (50 mg daily), followed by 3 weeks oral treatment (week 2, 21 mg daily; week 3-4, 7 mg daily). Patients were followed for 24 weeks.

Outcomes

Type Measure Time Frame Safety Issue
Primary Percentage of patients who were dead or dependent (modified Rankin score 3-5), Orgogozo Stroke Scale, modified Barthel Index after 24 weeks of treatment.

Sponsors

Janssen Pharmaceutica