Expired Study
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Long Beach, California 90822


Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

00624


NCT ID:

NCT00620165


Secondary ID:


Study Acronym:


Brief Title:

Efficacy of Levetiracetam in Essential Tremor


Official Title:

Efficacy of Levetiracetam in Patients With Essential Tremor


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

25 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Southern California Institute for Research and Education


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:January 2005
Completion Date:March 2008
Completion Type:Actual
Primary Completion Date:March 2008
Primary Completion Type:Actual
Verification Date:April 2009
Last Changed Date:April 16, 2009
First Received Date:February 11, 2008

Study Outcomes

Outcome Type: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Assessment of adverse side effects.
Time Frame:12 weeks per arm
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:levetiracetam
Description: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.
Arm Name:1
Other Name:keppra
Intervention Type:Drug
Name:placebo
Description: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.
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
Study Arm Type:Placebo Comparator
Arm Name:2

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Southern California Institute for Research and Education

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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