Zonisamide in the Treatment of Essential Tremor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00616343
Recruitment Status : Terminated (Principal Investigator left the study site on December 28, 2012.)
First Posted : February 15, 2008
Results First Posted : July 17, 2014
Last Update Posted : July 17, 2014
Information provided by (Responsible Party):
Loma Linda University

February 4, 2008
February 15, 2008
June 12, 2014
July 17, 2014
July 17, 2014
June 2003
October 2012   (Final data collection date for primary outcome measure)
Tremor Severity [ Time Frame: 4 weeks ]
PI has left the institution and we are unable to accurately assess the data from the remaining records.
Tremor Severity [ Time Frame: 4 weeks ]
Complete list of historical versions of study NCT00616343 on Archive Site
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Zonisamide in the Treatment of Essential Tremor
Pilot Study of Zonisamide in the Treatment of Essential Tremor
The purpose of this study is to determine if Zonisamide is effective in reducing tremors in patients with Essential Tremor.
The subjects will remain on their usual medication and a baseline assessment using the Fahn Tolosa Marin tremor rating scale will be performed and will be video taped.
Not Applicable
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Essential Tremor
Drug: Zonisamide
100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
Other Name: Zonegran
Active Comparator: Zonisamide
Intervention: Drug: Zonisamide
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2012
October 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Diagnosis of Essential Tremor based on the Tremor Investigational Group criteria for definite or probable Essential Tremor.
  2. Age: 18 years or over.
  3. Willingness and ability to comply with the study requirements and give informed consent.

Exclusion Criteria:

  1. Known history of psychiatric disorder, major depression, dementia, aplastic anemia, or Stevens-Johnson syndrome.
  2. Known alcohol or substance abuse in previous 12 months.
  3. Positive pregnancy test.
  4. Unwillingness to use adequate contraceptive methods if of childbearing potential.
  5. Known allergy to sulfonamides.
  6. Laboratory abnormalities prior to onset of trial.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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United States
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Loma Linda University
Loma Linda University
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Principal Investigator: David M Swope, MD Loma Linda University
Loma Linda University
July 2014

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