Efficacy of Levetiracetam in Essential Tremor

Southern California Institute for Research and Education

Status and phase: Completed; Phase 2; Phase 1

Conditions: Essential Tremor

Treatments: Drug: levetiracetam; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00620165

00624

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 25 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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10 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: levetiracetam

2

Placebo Comparator group

Treatment:

Drug: placebo