A Safety/Efficacy Trial of Zonisamide for Essential Tremor

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Greater Los Angeles Healthcare System
• Collaborator: Ralph M. Parsons Foundation
• Treatments: Zonisamide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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