A European multicenter randomized double-blind clinical trial of nimodipine versus placebo was conducted to evaluate the efficacy of nimodipine in acute middle cerebral artery stroke. Eight hundred and eighty patients were randomized with oral administration of 120 mg nimodipine daily or placebo for 21 days. A statistically significant difference in mortality, neurological or functional outcome was not found for either the group of all randomized patients or for patients complying with the protocol. Among the various subgroup analyses performed, only the one concerning patients treated with nimodipine within 12 h after onset of symptoms indicated a better but not statistically significant functional outcome at 3 months. The improved outcome in patients treated early is consistent with the findings of a recent meta-analysis of nimodipine stroke trials.

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