Randomized, Double-Blind, Placebo-Controlled Trial of Nimodipine in Acute Stroke "TRUST"
Completed
Phase 3 ResultsTrial Description
To determine the value of oral nimodipine 120 mg per day for acute stroke.
Interventions
- Nimodipine (NimotopĀ®)Drug
Other Names: The treatment group Intervention Desc: Calcium channel blocker (L-type calcium channels)
Trial Design
Randomized, double-blind, placebo-controlled multicenter study of 1215 patients at 17 British centers.
Patient Involvement
Patients were randomized to receive 120 mg oral nimodipine (n=608) or placebo (n=607).
Outcomes
Type | Measure | Time Frame | Safety Issue |
---|---|---|---|
Primary | Independence after 6 months, defined as a score of 60 or more on the Barthel index. | ||
Secondary | Mortality, Nottingham ADL score, change in Orgogozo neurological score. |
Recruitment
- Gender: Both
- Minimum Age: 40
- Study Size: 1,215
- Number of Centers: 17
- Max Time from Onset: 48 Hours
- Follow Up: 6 Months
Principal Investigator
- J.J. Murphy
Locations
- Britain