Zonisamide in the Treatment of Essential Tremor

• Sponsor: Loma Linda University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00616343
• Collaborator: (none)
• Enrollment: 9
• Arm: 1
• Duration (Months): 114

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Essential Tremor	Drug: Zonisamide	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pilot Study of Zonisamide in the Treatment of Essential Tremor
• Study Start Date: Jun 1, 2003
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Zonisamide	Drug: Zonisamide; 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.; Other Names: Zonegran

Outcome Measures

Primary Outcome Measures

1. Tremor Severity [4 weeks]

   PI has left the institution and we are unable to accurately assess the data from the remaining records.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Loma Linda University

Investigators

• Principal Investigator: David M Swope, MD, Loma Linda University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Loma Linda University
• ClinicalTrials.gov Identifier: NCT00616343
• Other Study ID Numbers: OSR#53157
• First Posted: Feb 15, 2008
• Last Update Posted: Jul 17, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Loma Linda University: ET
• Additional relevant MeSH terms: Tremor; Essential Tremor; Zonisamide

Study Results

Participant Flow

Arm/Group Title	Zonisamide
Arm/Group Description	Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
Period Title: Overall Study
STARTED	9
COMPLETED	9
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Zonisamide
Arm/Group Description	Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
Overall Participants	9
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	66.1 (16.33078)
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	4 44.4%
>=65 years	5 55.6%
Sex: Female, Male (Count of Participants)
Female	3 33.3%
Male	6 66.7%
Region of Enrollment (participants) [Number]
United States	9 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Zonisamide
Arm/Group Description	Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
Measure Participants	0

Adverse Events

Arm/Group Title	Zonisamide
Arm/Group Description	Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
All Cause Mortality
	Zonisamide
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Zonisamide
	Affected / at Risk (%)	# Events
Total	0/9 (0%)
Other (Not Including Serious) Adverse Events
	Zonisamide
	Affected / at Risk (%)	# Events
Total	0/9 (0%)

Limitations/Caveats

PI has left the institution and we are unable to accurately assess the data from the remaining records.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.