Zonisamide in the Treatment of Essential Tremor

This study has been terminated.
(Principal Investigator left the study site on December 28, 2012.)
Sponsor:
Information provided by (Responsible Party):
Loma Linda University
ClinicalTrials.gov Identifier:
NCT00616343
First received: February 4, 2008
Last updated: July 16, 2014
Last verified: July 2014
  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: 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:


Further study details as provided by Loma Linda University:

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


Enrollment: 9
Study Start Date: June 2003
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Zonisamide Drug: Zonisamide
100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
Other Name: Zonegran

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.

  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
ClinicalTrials.gov Identifier: NCT00616343     History of Changes
Other Study ID Numbers: OSR#53157
Study First Received: February 4, 2008
Results First Received: June 12, 2014
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014