Clinical Trial: A Safety/Efficacy Trial of Zonisamide for Essential Tremor
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Novel Therapies for Essential Tremor - Zonisamide Pilot Study
Brief Summary: The purpose of this pilot study is to obtain information whether the medication zonisamide reduces tremor in persons with essential tremor and is well tolerated.
Detailed Summary:
Essential tremor is common, affecting about four percent of the population above age 40 years. Of these, about half have troublesome tremor that warrants medical therapy, but only half of these find satisfactory treatment. Thus it can be estimated that about one million Americans have not been able to find adequate therapy for their essential tremor. Presently used medications may fail due to lack of efficacy or tolerance. After encountering anecdotal experience of zonisamide's efficacy for essential tremor we decided to conduct a single-site open-treatment rising-dose study with blinded videotape ratings of tremor. Zonisamide is presently on the market in the United States for epilepsy. Its use in other conditions is experimental.
Healthy participants with bilateral hand tremor will initially sign an IRB-approved informed consent form, then have assessments in a Screening Visit to determine that they are healthy (physical and neurological examinations, routine blood tests, electrocardiogram) and tremor assessments with rating scales. Tremor at each visit will be videotaped, as well as assessed openly by a rater. If participants meet eligibility criteria, they will return to a Baseline Visit (Visit 1) for repeat tremor assessment and the initial dispensation of zonisamide.
The study drug initially will taken as one 50-mg tablet a day, then the dose increased by one tablet each two weeks, to no more than 3 tablets (150 mg) taken twice a day. During this 12-week dose adjustment phase, the participant will be seen in clinic each 4 weeks for tremor assessments and review of health status. In addition, the participant will be contacted by telephone each week. If any symptom occurs suggestive of side effects, the escalation will be stopped or the dose reduced in order to resolve the symptom.
Original Secondary Outcome:
- Quality of life.
- Degree of tremor at the end of the extension phase compared to the beginning of the extension phase.
Information By: VA Greater Los Angeles Healthcare System
Dates:
Date Received: September 15, 2005
Date Started: November 2004
Date Completion:
Last Updated: June 20, 2012
Last Verified: June 2012
