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Carisbamate in essential tremor: Brief report of a proof of concept study
Author(s) -
Elble Rodger J.,
Biondi David M.,
Ascher Steve,
Wiegand Frank,
Hulihan Joseph
Publication year - 2010
Publication title -
movement disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.352
H-Index - 198
eISSN - 1531-8257
pISSN - 0885-3185
DOI - 10.1002/mds.22872
Subject(s) - placebo , crossover study , essential tremor , adverse effect , mood , medicine , psychology , rating scale , epilepsy , psychiatry , developmental psychology , alternative medicine , pathology
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