A Safety/Efficacy Trial of Zonisamide for Essential Tremor
Completed · Phase 2
Conditions studied: Essential Tremor
In brief
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.
Key facts
- Study ID
- NCT00223743
- Run by
- VA Greater Los Angeles Healthcare System
- People needed
- 25
- Starts
- 2004-11-01
- Last updated by the study team
- 2012-06-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- VA Greater Los Angeles — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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