Efficacy of Levetiracetam in Essential Tremor
Information source: Southern California Institute for Research and Education
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Essential Tremor
Intervention: levetiracetam (Drug); placebo (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Southern California Institute for Research and Education Official(s) and/or principal investigator(s): Steven S Schreiber, MD, Principal Investigator, Affiliation: Southern California Institute for Research and Education
Summary
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.
Clinical Details
Official title: Efficacy of Levetiracetam in Patients With Essential Tremor
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Performance on a 16-item tremor rating scale including degree of tremor, writing, pouring and feeding.
Secondary outcome: Assessment of adverse side effects.
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
Minimum age: 25 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
VA Long Beach Healthcare System, Long Beach, California 90822, United States
Additional Information
Starting date: January 2005
Last updated: April 16, 2009
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