Status:
COMPLETED
A Safety/Efficacy Trial of Zonisamide for Essential Tremor
Lead Sponsor:
VA Greater Los Angeles Healthcare System
Collaborating Sponsors:
Ralph M. Parsons Foundation
Conditions:
Essential Tremor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Description
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 s...
Eligibility Criteria
Inclusion
- age 18 or older
- diagnosis of essential tremor
- tremor present in both hands for at least one year
- tremor is bothersome in at least one hand, so that reduction of tremor would improve quality of life
- able to comply with study visits and procedures
- has voluntarily signed consent form
- able to abstain from alcohol for 12 hours prior to each visit, and from caffeine on day prior to visit
- taking no medications or stable doses of anti-tremor medication for 4 weeks prior to the Baseline visit
Exclusion
- medical condition likely to cause hospitalization during the study
- progressive neurological disorder other than essential tremor
- history of serious psychiatric illness
- history of drug or alcohol abuse in past year
- consumes more than two glasses of wine or equivalent per day
- has received botulinum toxin injection in past 6 months
- currently using experimental device
- has taken experimental drug within 5 half lives of its elimination
- has received deep brain stimulation in past two weeks or has potential need for this therapy during the study
- thalamotomy within the past 6 months
- taking medications judged by investigator to exacerbate tremor
- has probable cause of tremor other than essential tremor
- condition likely to interfere with absorption, metabolism or elimination of study drug
- hepatic disease
- renal disease
- history of renal stones
- history of allergy to sulfonamides
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00223743
Start Date
November 1 2004
Last Update
June 22 2012
Active Locations (1)
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1
VA Greater Los Angeles
Los Angeles, California, United States, 90073