Zonisamide in the Treatment of Essential Tremor

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2012-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Essential Tremor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Zonisamide

Group Type ACTIVE_COMPARATOR

Zonisamide

Intervention Type DRUG

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

Interventions

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Zonisamide

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

Intervention Type DRUG

Other Intervention Names

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Zonegran

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No