Efficacy of Levetiracetam in Essential Tremor

April 16, 2009 updated by: Southern California Institute for Research and Education

Efficacy of Levetiracetam in Patients With Essential Tremor

Essential tremor poses one of the greatest therapeutic challenges to neurologists. This study will examine the effectiveness of the drug, levetiracetam or keppra, for the treatment of essential tremor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Currently available pharmacological treatments for essential tremor are hampered by relatively low efficacy and intolerable side effects. Recent evidence indicates that levetiracetam (LEV) may modulate the dopaminergic system. In this regard LEV has been shown to reduce L-dopa-induced dyskinesias, tardive dyskinesia and myoclonus, and is relatively well-tolerated in the elderly. Previous studies examined the efficacy of LEV for the treatment of essential tremor. However, these were either open label or relatively short duration studies. A longer term study of LEV for the treatment of essential tremor is therefore warranted. In this randomized, double-blind, placebo-controlled crossover study, ten subjects with essential tremor will be randomly assigned to receive either LEV up to a maximum dose of 3000 milligrams (mg) per day or placebo. Study drug will be titrated up over 6 weeks and continued at 1500 mg twice daily for an additional 6 weeks. Following a 4 week washout period subjects will cross over to the other arm and continued for an additional 12 weeks. Subjects will be evaluated monthly by a blinded examining neurologist and research coordinator. At each study visit subjects will receive a neurological examination and will be evaluated using a 16-item scale for tremor and medication side effects. The data derived from study drug vs. placebo groups will be compared using the Mann-Whitney U and Wilcoxon W tests.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90822
        • VA Long Beach Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of tremor for 5 or more years
  • No other neurological problems

Exclusion Criteria:

  • Prior stroke or other neurological disease, psychiatric problems
  • History of renal disease
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: levetiracetam
Subjects will receive levetiracetam titrated up over 6 weeks to a maximum dose of 3000 milligrams (mg) per day, and then continue at 1500 mg twice daily for an additional 6 weeks.
Other Names:
  • keppra
Placebo Comparator: 2
Drug: placebo
Subjects will receive identical placebo titrated up over 6 weeks to a maximum daily dose, and then continue twice daily for an additional 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Performance on a 16-item tremor rating scale including degree of tremor, writing, pouring and feeding.
Time Frame: 12 weeks per treatment arm
12 weeks per treatment arm

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of adverse side effects.
Time Frame: 12 weeks per arm
12 weeks per arm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern California Institute for Research and Education

Investigators

  • Principal Investigator: Steven S Schreiber, MD, Southern California Institute for Research and Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

February 11, 2008

First Submitted That Met QC Criteria

February 20, 2008

First Posted (Estimate)

February 21, 2008

Study Record Updates

Last Update Posted (Estimate)

April 17, 2009

Last Update Submitted That Met QC Criteria

April 16, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00624

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Essential Tremor

Clinical Trials on levetiracetam

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe