Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2008

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.

Intervention(s) in this Clinical Trial

• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Performance on a 16-item tremor rating scale including degree of tremor, writing, pouring and feeding.
  • Time Frame: 12 weeks per treatment arm
    Safety Issue?: No

Secondary Measures

• Assessment of adverse side effects.
  • Time Frame: 12 weeks per arm
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 25 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Southern California Institute for Research and Education

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on August 27, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00620165

Study ID Number: 00624

ClinicalTrials.gov Identifier: NCT00620165

Health Authority: United States: Institutional Review Board