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A Safety/Efficacy Trial of Zonisamide for Essential Tremor

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ClinicalTrials.gov Identifier: NCT00223743
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : June 22, 2012
Sponsor:
Collaborator:
Ralph M. Parsons Foundation
Information provided by (Responsible Party):
Adrian Handforth, MD, VA Greater Los Angeles Healthcare System

Tracking Information
First Submitted Date  ICMJE September 15, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date June 22, 2012
Study Start Date  ICMJE November 2004
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2012)
The degree of tremor at the end of the dose adjustment phase compared to baseline. [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2005)
The degree of tremor at the end of the dose adjustment phase compared to baseline.
Change History Complete list of historical versions of study NCT00223743 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2012)
  • Quality of life. [ Time Frame: 6 months ]
  • Degree of tremor at the end of the extension phase compared to the beginning of the extension phase. [ Time Frame: 5 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2005)
  • Quality of life.
  • Degree of tremor at the end of the extension phase compared to the beginning of the extension phase.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety/Efficacy Trial of Zonisamide for Essential Tremor
Official Title  ICMJE 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 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 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.

At the end of the 12-week dose adjustment phase, at Visit 4, it will be determined whether meaningful tremor reduction has occurred at the target dose of 300 mg per day or at a lesser but tolerated dose. If not, the participant will discontinue from the study. If benefit has occurred, the subject will be invited to continue taking zonisamide for another 12 weeks, at the conclusion of which the participant will be seen in the final visit (Visit 5).

The videotapes will be coded so that the order they were made is not apparent, and the degree of tremor will be rated by a rater who does not know the study participants.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Essential Tremor
Intervention  ICMJE Drug: Zonisamide
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.
Study Arms  ICMJE Experimental: Zonisamide
Zonisamide administration and tremor assessment to assess efficacy in reducing essential tremor
Intervention: Drug: Zonisamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2005)
25
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00223743
Other Study ID Numbers  ICMJE 0030
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adrian Handforth, MD, VA Greater Los Angeles Healthcare System
Study Sponsor  ICMJE VA Greater Los Angeles Healthcare System
Collaborators  ICMJE Ralph M. Parsons Foundation
Investigators  ICMJE
Principal Investigator: Adrian Handforth, M.D. Veterans Affairs Greater Los Angeles
PRS Account VA Greater Los Angeles Healthcare System
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP