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Published on: December 13, 2017
Carisbamate in essential tremor: brief report of a proof of concept study
Rodger J Elble1, David M Biondi, Steve Ascher
1Southern Illinois University School of Medicine, Springfield, Illinois 62794-9643, USA. relble@siumed.edu
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.
Insights
Carisbamate, a neuromodulator for epilepsy, did not show significant benefits for essential tremor patients compared to placebo. The investigational drug was well-tolerated, with similar adverse events to placebo.
Area of Science:
- Neurology
- Clinical Pharmacology
Background:
- Essential tremor (ET) is a common neurological disorder.
- Current treatments for ET have limitations, necessitating novel therapeutic approaches.
Purpose of the Study:
- To evaluate the efficacy and safety of carisbamate in patients with essential tremor.
- To assess carisbamate's impact on tremor severity, mood, and quality of life.
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled, crossover study.
- Sixty-two patients received carisbamate 400 mg/day or placebo for two 21-day periods.
- The Fahn-Tolosa-Marín Tremor Rating Scale (TRS) was the primary outcome measure.
Main Results:
- No significant difference was observed between carisbamate and placebo in improving TRS scores (P = 0.94).
- Carisbamate did not demonstrate superiority over placebo in affecting mood or quality of life measures.
- The adverse event profile of carisbamate was comparable to placebo, indicating good tolerability.
Conclusions:
- Carisbamate did not prove effective in treating essential tremor in this study population.
- Further research may be needed to explore other potential indications or dosages for carisbamate.
- Carisbamate appears to be a safe investigational neuromodulator with a tolerability profile similar to placebo.
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