Neurology
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Randomized Controlled Trial Multicenter Study
Double-blind placebo-controlled trial of adjunctive levetiracetam in pediatric partial seizures.
To evaluate the efficacy and tolerability of levetiracetam (LEV) as adjunctive therapy in children (4 to 16 years) with treatment-resistant partial-onset seizures. ⋯ Levetiracetam adjunctive therapy administered at 60 mg/kg/day is efficacious and well tolerated in children with treatment-resistant partial seizures.
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Randomized Controlled Trial
Hematoma growth is a determinant of mortality and poor outcome after intracerebral hemorrhage.
Although volume of intracerebral hemorrhage (ICH) is a predictor of mortality, it is unknown whether subsequent hematoma growth further increases the risk of death or poor functional outcome. ⋯ Hematoma growth is an independent determinant of both mortality and functional outcome after intracerebral hemorrhage. Attenuation of growth is an important therapeutic strategy.
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Randomized Controlled Trial Multicenter Study Comparative Study
A Phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses.
Teriflunomide, a dihydro-orotate dehydrogenase inhibitor, has immunomodulatory effects, including the ability to suppress experimental allergic encephalomyelitis. In this randomized, double-blind, placebo-controlled Phase II study, the authors examined the safety and efficacy of oral teriflunomide in multiple sclerosis (MS) with relapses. ⋯ Oral teriflunomide was effective in reducing MRI lesions and was well tolerated in patients with relapsing multiple sclerosis.
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Randomized Controlled Trial Multicenter Study
A randomized, double-blind, futility clinical trial of creatine and minocycline in early Parkinson disease.
Creatine and minocycline were prioritized for testing in Phase II clinical trials based on a systematic evaluation of potentially disease modifying compounds for Parkinson disease (PD). ⋯ Both creatine and minocycline should be considered for definitive Phase III trials to determine if they alter the long term progression of Parkinson disease (PD). Additional factors must be weighed before selecting agents for Phase III trials, including safety, tolerability, activity, cost, and availability of these two agents in comparison with other agents currently in development for PD.
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Randomized Controlled Trial Multicenter Study
Pentoxifylline in ALS: a double-blind, randomized, multicenter, placebo-controlled trial.
To assess the efficacy and safety of pentoxifylline, a US Food and Drug Administration-approved drug, in patients with ALS treated with riluzole. ⋯ Pentoxifylline is not beneficial in ALS and should be avoided in patients treated with riluzole. The discrepancy between survival and measures of functional changes urges caution in equating these end points in phase III trials, and suggests that both survival and function should be used in phase III trials.