Zonisamide in the Treatment of Essential Tremor

July 16, 2014 updated by: Loma Linda University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Zonisamide
Drug: Zonisamide
100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
Other Names:
  • Zonegran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tremor Severity
Time Frame: 4 weeks
PI has left the institution and we are unable to accurately assess the data from the remaining records.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: David M Swope, MD, Loma Linda University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 4, 2008

First Submitted That Met QC Criteria

February 13, 2008

First Posted (Estimate)

February 15, 2008

Study Record Updates

Last Update Posted (Estimate)

July 17, 2014

Last Update Submitted That Met QC Criteria

July 16, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSR#53157

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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