Zonisamide in the Treatment of Essential Tremor

This study is ongoing, but not recruiting participants.

First Received: February 4, 2008 Last Updated: September 11, 2008 History of Changes

Sponsored by:	Loma Linda University
Information provided by:	Loma Linda University
ClinicalTrials.gov Identifier:	NCT00616343

Purpose

The purpose of this study is to determine if Zonisamide is effective in reducing tremors in patients with Essential Tremor.

Condition	Intervention
Essential Tremor	Drug: Zonisamide

Genetics Home Reference related topics: essential tremor familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Tremor

Drug Information available for: Zonisamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind (Outcomes Assessor), Single Group Assignment, Efficacy Study
Official Title:	Pilot Study of Zonisamide in the Treatment of Essential Tremor

Further study details as provided by Loma Linda University:

Primary Outcome Measures:

Tremor severity [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	June 2003
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Zonisamide 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Known history of psychiatric disorder, major depression, dementia, aplastic anemia, or Stevens-Johnson syndrome.
Known alcohol or substance abuse in previous 12 months.
Positive pregnancy test.
Unwillingness to use adequate contraceptive methods if of childbearing potential.
Known allergy to sulfonamides.
Laboratory abnormalities prior to onset of trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616343

Sponsors and Collaborators

Loma Linda University

Investigators

Principal Investigator:

David M Swope, MD

Loma Linda University

More Information

No publications provided

Responsible Party:	Loma Linda University ( David Swope, MD )
Study ID Numbers:	OSR#53157
Study First Received:	February 4, 2008
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00616343 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Loma Linda University:

Study placed in the following topic categories:

Signs and Symptoms
Essential Tremor
Antioxidants
Movement Disorders
Zonisamide
Central Nervous System Diseases

Neurologic Manifestations
Benign Essential Tremor Syndrome
Dyskinesias
Tremor
Anticonvulsants

Additional relevant MeSH terms:

Essential Tremor
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Zonisamide
Central Nervous System Diseases
Tremor
Dyskinesias

Protective Agents
Pharmacologic Actions
Signs and Symptoms
Movement Disorders
Therapeutic Uses
Neurologic Manifestations
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009