OBJECTIVE: To analyze the effect of nimodipine in patients with intractable epilepsy. DESIGN: We conducted a double-blind placebo-controlled crossover study in 95 patients. MATERIAL AND METHODS: The dihydropyridine calcium antagonist nimodipine was used as add-on therapy (60 mg four times a day) in a 1-year placebo-controlled crossover study in 71 patients with localization-related epilepsy and 24 with generalized seizure disorders. Of the 95 patients, 81 were receiving two or more antiepileptic drugs. Patients diaries were used to record the number of seizures and any side effects. RESULTS:Nimodipine seemed to be well tolerated during the study; only two patients were unable to complete the study because of probable adverse effects. The trial demonstrated no significant crossover effect and no significant effect of nimodipine on either the mean or the median number of seizures or seizure days. The peak median serum nimodipine level was less than 5 ng/mL in the 78 patients who completed the study. CONCLUSION: This clinical trial found no beneficial effect with use of nimodipine as add-on therapy for intractable epilepsy. Potential reasons for the absence of efficacy of nimodipine may be the inclusion of patients with very refractory seizure disorders or the relatively low serum nimodipine concentrations related to the pharmacokinetic effect of concurrent antiepileptic medication.
RCT Entities:
OBJECTIVE: To analyze the effect of nimodipine in patients with intractable epilepsy. DESIGN: We conducted a double-blind placebo-controlled crossover study in 95 patients. MATERIAL AND METHODS: The dihydropyridine calcium antagonist nimodipine was used as add-on therapy (60 mg four times a day) in a 1-year placebo-controlled crossover study in 71 patients with localization-related epilepsy and 24 with generalized seizure disorders. Of the 95 patients, 81 were receiving two or more antiepileptic drugs. Patients diaries were used to record the number of seizures and any side effects. RESULTS:Nimodipine seemed to be well tolerated during the study; only two patients were unable to complete the study because of probable adverse effects. The trial demonstrated no significant crossover effect and no significant effect of nimodipine on either the mean or the median number of seizures or seizure days. The peak median serum nimodipine level was less than 5 ng/mL in the 78 patients who completed the study. CONCLUSION: This clinical trial found no beneficial effect with use of nimodipine as add-on therapy for intractable epilepsy. Potential reasons for the absence of efficacy of nimodipine may be the inclusion of patients with very refractory seizure disorders or the relatively low serum nimodipine concentrations related to the pharmacokinetic effect of concurrent antiepileptic medication.