Abstract | BACKGROUND: METHODS: In this multicenter, double-blind, placebo-controlled, parallel-design trial, patients with moderate to severe essential tremor of the upper limbs were randomized to 24 weeks of treatment with placebo or topiramate (target dose, 400 mg/day) as monotherapy or as an adjunct to one antitremor medication. The primary efficacy variable was the final visit tremor score based on the Fahn-Tolosa-Marin Tremor Rating Scale (TRS). RESULTS: The intent-to-treat population was 208 patients ( topiramate, 108; placebo, 100). The final visit score (last observation carried forward) was lower in the topiramate group than with placebo (p < 0.001). Mean percentage improvement in overall TRS scores was 29% with topiramate at a mean final dose of 292 mg/day and 16% with placebo (p < 0.001). Topiramate was associated with greater improvement in function and disability (p = 0.001). A between-group difference (p < 0.001) was observed at the first on-treatment visit at 4 weeks when the target topiramate dose was 100 mg/day (mean achieved dose, 62 +/- 9 mg/day). The most common treatment-limiting adverse events in topiramate-treated patients were paresthesia (5%), nausea (3%), concentration/attention difficulty (3%), and somnolence (3%). Adverse events were treatment limiting in 31.9% of topiramate patients and 9.5% of placebo patients. CONCLUSIONS:
Topiramate was effective in the treatment of moderate to severe essential tremor. Tremor reduction was accompanied by functional improvements, such as in motor tasks, writing, and speaking.
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Authors | W G Ondo, J Jankovic, G S Connor, R Pahwa, R Elble, M A Stacy, W C Koller, L Schwarzman, S-C Wu, J F Hulihan, Topiramate Essential Tremor Study Investigators |
Journal | Neurology
(Neurology)
Vol. 66
Issue 5
Pg. 672-7
(Mar 14 2006)
ISSN: 1526-632X [Electronic] United States |
PMID | 16436648
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Neuroprotective Agents
- Placebos
- Topiramate
- Fructose
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Topics |
- Adult
- Aged
- Double-Blind Method
- Essential Tremor
(drug therapy)
- Fructose
(adverse effects, analogs & derivatives, therapeutic use)
- Functional Laterality
- Humans
- Middle Aged
- Neuroprotective Agents
(adverse effects, therapeutic use)
- Placebos
- Posture
- Topiramate
- Treatment Outcome
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