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

February 4, 2008
July 16, 2014
June 2003
October 2012   (final data collection date for primary outcome measure)
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.
Tremor severity [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00616343 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Zonisamide in the Treatment of Essential Tremor
Pilot Study of Zonisamide in the Treatment of Essential Tremor

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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Essential Tremor
Drug: Zonisamide
100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
Other Name: Zonegran
Active Comparator: Zonisamide
Intervention: Drug: Zonisamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
December 2012
October 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00616343
OSR#53157
Yes
Loma Linda University
Loma Linda University
Not Provided
Principal Investigator: David M Swope, MD Loma Linda University
Loma Linda University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP