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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.
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine if Zonisamide is effective in reducing tremors in patients with Essential Tremor.

Condition or disease Intervention/treatment
Essential Tremor Drug: Zonisamide

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Zonisamide in the Treatment of Essential Tremor
Study Start Date : June 2003
Primary Completion Date : October 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor
Drug Information available for: Zonisamide
U.S. FDA Resources

Arms and Interventions

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 Name: Zonegran


Outcome Measures

Primary Outcome Measures :
  1. Tremor Severity [ Time Frame: 4 weeks ]
    PI has left the institution and we are unable to accurately assess the data from the remaining records.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616343


Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: David M Swope, MD Loma Linda University
More Information

Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT00616343     History of Changes
Other Study ID Numbers: OSR#53157
First Posted: February 15, 2008    Key Record Dates
Results First Posted: July 17, 2014
Last Update Posted: July 17, 2014
Last Verified: July 2014

Keywords provided by Loma Linda University:
ET

Additional relevant MeSH terms:
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Zonisamide
Anticonvulsants
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs