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Carisbamate in essential tremor: Brief report of a proof of concept study
Authors:Rodger J Elble MD  PhD  David M Biondi DO  Steve Ascher PhD  Frank Wiegand MD  PhD  Joseph Hulihan MD
Institution:1. Southern Illinois University School of Medicine, Springfield, Illinois, USA;2. Ortho‐McNeil Janssen Scientific Affairs, LLC, Raritan, New Jersey, USA;3. Johnson & Johnson Pharmaceutical Services, LLC, Raritan, New Jersey, USA
Abstract:The 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. © 2010 Movement Disorder Society
Keywords:carisbamate  essential tremor  adults  RWJ‐333369
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