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Trial record 18 of 52 for:    "Benign essential tremor syndrome"
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Zonisamide in the Treatment of Essential Tremor

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Loma Linda University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Loma Linda University
ClinicalTrials.gov Identifier:
NCT00616343
First received: February 4, 2008
Last updated: September 11, 2008
Last verified: September 2008
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Zonisamide in the Treatment of Essential Tremor

Resource links provided by NLM:

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

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
Active Comparator: 1 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:

  1. Diagnosis of Essential Tremor based on the Tremor Investigational Group criteria for definite or probable ET.
  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
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: David Swope, MD, Loma Linda University
ClinicalTrials.gov Identifier: NCT00616343     History of Changes
Other Study ID Numbers: OSR#53157
Study First Received: February 4, 2008
Last Updated: September 11, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
ET

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

ClinicalTrials.gov processed this record on May 22, 2013