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From the Baylor College of Medicine (W.G.O., J.J.), Houston, TX; Neurological Center of Oklahoma (G.S.C.), Tulsa; University of Kansas Medical Center (R.P.), Kansas City; Southern Illinois University School of Medicine (R.E.), Springfield; Duke University Medical Center (M.A.S.), Durham, NC; University of North Carolina (W.C.K.), Chapel Hill; and Ortho-McNeil Neurologics, Inc. (L.S., SC.W., J.F.H.), Titusville, NJ.
Address correspondence and reprint requests to Dr Ondo at Parkinson’s Disease and Movement Disorders Center, Baylor College of Medicine, 6550 Fannin St., Suite 1801, Houston, TX 77030; e-mail: wondo{at}bc.tmc.edu.
Background: Essential tremor is most prevalent and most disabling in older patients. Additional therapies are required for patients with an inadequate response or intolerable side effects. In small trials, topiramate appeared to be beneficial in essential tremor.
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.
This article was previously published in electronic format as an Expedited E-Pub on January 25, 2006, at www.neurology.org.
*See the Appendix for a list of Group members.
Deceased.
Sponsored by Ortho-McNeil Neurologics, Inc., Titusville, NJ.
Disclosure: William G. Ondo, MD, Joseph Jankovic, MD, Gregory S. Connor, MD, Rajesh Pahwa, MD, Rodger Elble, MD, PhD, Mark A. Stacy, MD, and William C. Koller, MD, PhD, all received grant support for participating in the study. Additional industry affiliations include William Ondo, MD: speaker bureau/consulting—GlaxoSmithKline, Allergan, Pfizer, Novartis, TEVA, grant support—Orphan Medical, Boehringer Ingelheim, Titan Pharmaceuticals, Novartis; Joseph Jankovic, MD: speaker bureau/consulting—GlaxoSmithKline, Allergan, Novartis, Pfizer, grant support—Allergan, Medtronic, Cephalon, Novartis; Gregory S. Connor, MD: speaker bureau/consulting—Ortho-McNeil, GlaxoSmithKline, Pfizer; Rajesh Pahwa, MD: speaker bureau/consulting—GlaxoSmithKline, UCB Pharma, Medtronic, Novartis, grant support—GlaxoSmithKline, Pfizer, Novartis, Cephalon, TEVA, UCB Pharma, Boehringer Ingelheim; Rodger Elble, MD, PhD: speaker bureau/consulting—GlaxoSmithKline, Kinetics, UCB Pharma, Schlesinger Associates, Ortho-McNeil, stock—Pfizer, Eli Lilly, Merck, GlaxoSmithKline; Mark A. Stacy, MD: speaker bureau/consulting—Amersham, Berteck, Guilford Medical Safety Board, advisory committees for Kyowa, GlaxoSmithKline, grant support—Ipsen, GlaxoSmithKline, Amgen, Novartis; William C. Koller, MD, PhD: speaker bureau/consulting—GlaxoSmithKline, Novartis, Valient, Pfizer. Lesley Schwarzman, MBA, Shu-Chen Wu, PhD, and Joseph F. Hulihan, MD are employees of Ortho-McNeil Pharmaceutical, Raritan, NJ. Shu-Chen Wu, PhD, and Joseph F. Hulihan, MD, have an equity interest or ownership interest in Ortho-McNeil Pharmaceutical in excess of $10,000.
Received April 26, 2005. Accepted in final form October 5, 2005.
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