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Topiramate Effective in Essential Tremor: Presented at AAN

By Jill Stein

SAN FRANCISCO, CA -- May 3, 2004 -- The anti-epileptic drug topiramate is effective as add-on therapy or monotherapy in patients with moderate to severe upper-extremity tremor, researchers reported here on April 27^th at the American Academy of Neurology 56^th Annual Meeting.

The estimated occurrence of essential tremor ranges from 0.4% to 4% in the general population, and is at least 5% in the elderly, making it one of the most common movement disorders.

Aided by colleagues across the United States, William Ondo, Baylor College of Medicine, Houston, Texas, randomised 223 patients with essential tremor to topiramate or placebo. The mean age of the study population was 62 (plus or minus 13.2 years).

After randomisation, doses were titrated over 12 weeks to the dose at which tremor resolved or to the maximum tolerated dose (400 mg/d was the maximum allowed dose). This dose remained the same during the 12-week maintenance phase.

Overall, 108 topiramate patients and 100 placebo subjects received the study medication, and had at least 1 on-treatment efficacy assessment.

Total normalised scores on the Fahn-Tolosa-Marin Tremor Rating Scale (TRS) improved 29% from baseline with topiramate and 16% with placebo (P <.001).

Improvements in scores favouring topiramate over placebo trended towards significance for Tremor Location/Severity (P =.06); between-group score differences for the other two TRS subscales were also significant (P <.001).

Differences between the groups in the Patient and Investigator Global Assessments were significant (P <.001).

Tremor control was rated as "good" or "very good" by 72% of topiramate-treated patients and 69% of investigators versus 15% of placebo-treated patients and 20% of investigators.

The adverse-event profile associated with topiramate was not substantially different either qualitatively or quantitatively from that found in other populations (e.g., epileptics, migraine sufferers), despite the use of a high target dosage in an older population, and the use of concomitant anti-tremor agents in about 50% of the patients.

Dr. Ondo said that additional studies are needed to determine the minimum effective dose warranted.

Topiramate is approved for use as adjunctive therapy in adults and paediatric patients with various seizure types and epilepsy syndromes.

This study was sponsored by Ortho-McNeil Pharmaceuticals.


[Presentation title: "Topiramate in essential tremor: a multicenter, double-blind, placebo-controlled trial." Abstract #LBS. 004]

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