Zonisamide in the Treatment of Essential Tremor

This study is ongoing, but not recruiting participants.

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

MedlinePlus related topics: Tremor

Drug Information available for: Zonisamide

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:

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

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

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
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
Movement Disorders
Benign essential tremor syndrome
Zonisamide

Central Nervous System Diseases
Neurologic Manifestations
Dyskinesias
Tremor

Additional relevant MeSH terms:

Antioxidants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases

Central Nervous System Agents
Protective Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009