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Sponsored by: |
Southern California Institute for Research and Education |
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Information provided by: | Southern California Institute for Research and Education |
ClinicalTrials.gov Identifier: | NCT00620165 |
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 |
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Essential Tremor |
Drug: levetiracetam Drug: placebo |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of Levetiracetam in Patients With Essential Tremor |
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 |
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1: Experimental |
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.
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2: Placebo Comparator |
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.
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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.
Ages Eligible for Study: | 25 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
VA Long Beach Healthcare System | |
Long Beach, California, United States, 90822 |
Principal Investigator: | Steven S Schreiber, MD | Southern California Institute for Research and Education |
Responsible Party: | Southern California Institute for Research and Education ( Steven S. Schreiber, MD ) |
Study ID Numbers: | 00624 |
Study First Received: | February 11, 2008 |
Last Updated: | June 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00620165 |
Health Authority: | United States: Institutional Review Board |
tremor writing feeding pouring |
Signs and Symptoms Essential Tremor Movement Disorders Benign essential tremor syndrome Central Nervous System Diseases |
Neurologic Manifestations Etiracetam Dyskinesias Tremor |
Nootropic Agents Therapeutic Uses Nervous System Diseases |
Central Nervous System Agents Pharmacologic Actions Anticonvulsants |