Zonisamide in the Treatment of Essential Tremor

Essential Tremor Clinical Trial

Official title:

Pilot Study of Zonisamide in the Treatment of Essential Tremor

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00616343
• Other study ID #: OSR#53157
• Status: Terminated
• Phase: N/A
• First received: February 4, 2008
• Last updated: July 16, 2014
• Start date: June 2003
• Est. completion date: December 2012

Study information

• Verified date: July 2014
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

Drug:
• Zonisamide
100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tremor Severity	PI has left the institution and we are unable to accurately assess the data from the remaining records.	4 weeks	Yes