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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
February 11, 2008
February 21, 2008
October 12, 2017
January 2005
March 2008   (Final data collection date for primary outcome measure)
Performance on a 16-item tremor rating scale including degree of tremor, writing, pouring and feeding. [ Time Frame: 12 weeks per treatment arm ]
Same as current
Complete list of historical versions of study NCT00620165 on ClinicalTrials.gov Archive Site
Assessment of adverse side effects. [ Time Frame: 12 weeks per arm ]
Same as current
Not Provided
Not Provided
 
Efficacy of Levetiracetam in Essential Tremor
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.
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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Essential Tremor
  • 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
  • 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.
  • Experimental: 1
    Intervention: Drug: levetiracetam
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
March 2008
March 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
25 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00620165
00624
No
Not Provided
Not Provided
Steven S. Schreiber, MD, Southern California Institute for Research and Education
Southern California Institute for Research and Education
Not Provided
Principal Investigator: Steven S Schreiber, MD Southern California Institute for Research and Education
Southern California Institute for Research and Education
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP