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Title: Levetiracetam Provides No Benefit in Essential Tremor: Presented at ANA

"Levetiracetam Provides No Benefit in Essential Tremor: Presented at ANA"

By Jill Stein SAN FRANCISCO, CA -- October 24, 2003 -- Levetiracetam is well tolerated but fails to consistently improve tremor, according to the results of a 4-week trial reported here October 19th at the 128th Annual Meeting of the American Neurological Association. Essential tremor is very common, with an estimated prevalence ranging from 0.5 to 5% for the entire population. J. Ernesto Jimenez, BS, and colleagues at Baylor College of Medicine, Houston, Texas, United States, presented the results of the brief, open-label trial of levetiracetam in which the drug was given as adjunctive therapy in 10 patients diagnosed with essential tremor. Levetiracetam is approved as add-on therapy for partial-onset seizures, and has also demonstrated efficacy for multiple seizure types and myoclonus. In the present study, patients evaluated with the Tremor Rating scale reported global impressions and adverse events before treatment, then again after 2 weeks on low-dose 500 mg twice daily, and once more at 4 weeks (after 2 weeks on a high dose of 1500 mg twice daily). All 10 patients completed the trial. Results showed that levetiracetam did not improve tremor at either the low or high dose. Specifically, there was no change in the Activities of Daily Living scores, observed tremor scores, handwriting scores, pouring scores, and drawing scores. Global impressions and Visual Analogue Scale also showed no meaningful improvement. There was no difference between low-dose and high-dose levetiracetam. Drug-induced adverse events were mild, and included dizziness in 2 patients, sedation in 1 patient, and nervousness in 1 patient. There was no difference in adverse events between the low- and high-dose levetiracetam groups. Mr. Jimenez emphasised that open-label studies are subject to biases of both the patient and the examiner, and added that several factors or methods may have minimised the potential efficacy of levetiracetam. "First, we are a tertiary-referral center, and tend to treat more refractory patients," he said. "All of these patients had failed prior treatments for essential tremor." Secondly, he noted, the trial has methodological limitations, including a small sample size and short duration. Thirdly, the dosing was based on seizure dosing, and may be inadequate for essential tremor, Mr. Jimenez said. Nevertheless, the results do not support controlled trials at these doses. Finally, Mr. Jimenez noted that future trials may consider a longer treatment duration, different dosing, or testing the drug in de novo subjects. [Study Title: Levetiracetam For Essential Tremor. Abstract 18]

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