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Randomized Controlled Trial Multicenter Study Clinical Trial
Carisbamate in essential tremor: brief report of a proof of concept study.
- Rodger J Elble, David M Biondi, Steve Ascher, Frank Wiegand, and Joseph Hulihan.
- Southern Illinois University School of Medicine, Springfield, Illinois 62794-9643, USA. relble@siumed.edu
- Mov. Disord. 2010 Apr 15;25(5):634-8.
AbstractThe efficacy and safety of carisbamate, an investigational neuromodulator currently in development for epilepsy, were examined in a multicenter, randomized, double-blind, cross-over, placebo-controlled study of essential tremor. Sixty-two patients (intent-to-treat analysis set; mean age 64 years; 66% men) received carisbamate 400 mg/day or matching placebo in a crossover study design with two 21-day treatment periods. The Fahn-Tolosa-Marín Tremor Rating Scale (TRS) was the primary assessment tool. Carisbamate and placebo treatment did not differ in their effect on the TRS (P = 0.94) or on measures of affect, mood, or quality of life. Carisbamate was generally well tolerated and had an adverse event profile comparable to that of placebo.(c) 2010 Movement Disorder Society.
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