Back to resultsZonisamide in the Treatment of Essential Tremor
Primary Purpose
Essential Tremor
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Zonisamide
Sponsored by
About this trial
This is an interventional treatment trial for Essential Tremor focused on measuring ET
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Essential Tremor based on the Tremor Investigational Group criteria for definite or probable Essential Tremor.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Zonisamide
Arm Description
Outcomes
Primary Outcome Measures
Tremor Severity
PI has left the institution and we are unable to accurately assess the data from the remaining records.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00616343
Brief Title
Zonisamide in the Treatment of Essential Tremor
Official Title
Pilot Study of Zonisamide in the Treatment of Essential Tremor
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Why Stopped
Principal Investigator left the study site on December 28, 2012.
Study Start Date
June 2003 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if Zonisamide is effective in reducing tremors in patients with Essential Tremor.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
ET
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zonisamide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Zonisamide
Other Intervention Name(s)
Zonegran
Intervention Description
100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
Primary Outcome Measure Information:
Title
Tremor Severity
Description
PI has left the institution and we are unable to accurately assess the data from the remaining records.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Essential Tremor based on the Tremor Investigational Group criteria for definite or probable Essential Tremor.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Swope, MD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Zonisamide in the Treatment of Essential Tremor
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