Neurology
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
A dose-comparison trial of topiramate as monotherapy in recently diagnosed partial epilepsy.
To evaluate topiramate as monotherapy in adults and children with recently diagnosed, localization-related epilepsy, comparing two dosages of topiramate in a multicenter, randomized, double-blind study. ⋯ Although the primary efficacy analysis was negative, time-to-exit analyses that included time-to-first-seizure as a covariate, between-group differences in seizure-free rates, and longer time-to-first-seizure with higher serum concentration provide evidence that topiramate is effective as monotherapy in patients with localization-related epilepsy.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Acute migraine treatment with droperidol: A randomized, double-blind, placebo-controlled trial.
The treatment of a migraine attack can be difficult when first-line medication is unsuccessful and options for parenteral "rescue" therapy are limited. ⋯ A total of 331 patients were enrolled; 305 were treated. Headache response at 2 hours was better (p < 0.002) in the treatment groups receiving droperidol IM at doses of 2.75 mg (87%), 5.5 mg (81%), and 8.25 mg (85%) compared with placebo (57%). The percent of patients achieving a pain-free response at 2 hours after treatment was significantly greater than placebo for the droperidol 2.75-mg, 5.5-mg, and 8.25-mg dose groups. The frequency of headache recurrence (within 24 hours) for patients initially responding by 2 hours was lower in patients treated with droperidol than placebo, but differences failed to reach significance. A significantly greater percentage of patients receiving droperidol 2.75 mg reported the elimination of migraine-associated symptoms (nausea, vomiting, photophobia, and phonophobia) than those who received placebo. Although most adverse events were of mild or moderate intensity, anxiety, akathisia, and somnolence were rated as severe in 30% of patients who experienced those symptoms. Hypotension was uncommon. No patient had QT prolongation.