A Safety/Efficacy Trial of Zonisamide for Essential Tremor

NCT00223743 | Completed Phase 2

• 1 other identifier: 0030
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to obtain information whether the medication zonisamide reduces tremor in persons with essential tremor and is well tolerated.

Conditions

Essential Tremor

Keywords

essential tremor; zonisamide; clinical trial

Outcome Measures

Primary Outcomes (1)

• The degree of tremor at the end of the dose adjustment phase compared to baseline.

  3 months

Secondary Outcomes (2)

• Quality of life.

  6 months

• Degree of tremor at the end of the extension phase compared to the beginning of the extension phase.

  5 months

Study Arms (1)

Zonisamide

EXPERIMENTAL

Zonisamide administration and tremor assessment to assess efficacy in reducing essential tremor

Drug: Zonisamide

Interventions

Zonisamide DRUG

study drug initially will taken as one 50-mg tablet a day, then the dose increased by one tablet each two weeks, to no more than 3 tablets (150 mg) taken twice a day.

Zonisamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 or older
• diagnosis of essential tremor
• tremor present in both hands for at least one year
• tremor is bothersome in at least one hand, so that reduction of tremor would improve quality of life
• able to comply with study visits and procedures
• has voluntarily signed consent form
• able to abstain from alcohol for 12 hours prior to each visit, and from caffeine on day prior to visit
• taking no medications or stable doses of anti-tremor medication for 4 weeks prior to the Baseline visit

You may not qualify if:

• medical condition likely to cause hospitalization during the study
• progressive neurological disorder other than essential tremor
• history of serious psychiatric illness
• history of drug or alcohol abuse in past year
• consumes more than two glasses of wine or equivalent per day
• has received botulinum toxin injection in past 6 months
• currently using experimental device
• has taken experimental drug within 5 half lives of its elimination
• has received deep brain stimulation in past two weeks or has potential need for this therapy during the study
• thalamotomy within the past 6 months
• taking medications judged by investigator to exacerbate tremor
• has probable cause of tremor other than essential tremor
• condition likely to interfere with absorption, metabolism or elimination of study drug
• hepatic disease
• renal disease

Sponsors & Collaborators

• VA Greater Los Angeles Healthcare System: lead
• Ralph M. Parsons Foundation: collaborator

Study Sites (1)

VA Greater Los Angeles

Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Essential Tremor

Interventions

Zonisamide

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Adrian Handforth, M.D.

  Veterans Affairs Greater Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Chief, Neurology, VAMC

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 22, 2005
• Study Start: November 1, 2004
• Primary Completion: September 1, 2008
• Last Updated: June 22, 2012

Record last verified: 2012-06

Locations

US (1)