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Efficacy of Levetiracetam in Essential Tremor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00620165
First Posted: February 21, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Southern California Institute for Research and Education
  Purpose
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.

Condition Intervention Phase
Essential Tremor Drug: levetiracetam Drug: placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Levetiracetam in Patients With Essential Tremor

Resource links provided by NLM:


Further study details as provided by Southern California Institute for Research and Education:

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

Secondary Outcome Measures:
  • Assessment of adverse side effects. [ Time Frame: 12 weeks per arm ]

Enrollment: 10
Study Start Date: January 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00620165


Locations
United States, California
VA Long Beach Healthcare System
Long Beach, California, United States, 90822
Sponsors and Collaborators
Southern California Institute for Research and Education
Investigators
Principal Investigator: Steven S Schreiber, MD Southern California Institute for Research and Education
  More Information

Responsible Party: Steven S. Schreiber, MD, Southern California Institute for Research and Education
ClinicalTrials.gov Identifier: NCT00620165     History of Changes
Other Study ID Numbers: 00624
First Submitted: February 11, 2008
First Posted: February 21, 2008
Last Update Posted: October 12, 2017
Last Verified: April 2009

Keywords provided by Southern California Institute for Research and Education:
tremor
writing
feeding
pouring

Additional relevant MeSH terms:
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Etiracetam
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs