NCT00620165

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

April 17, 2009

Status Verified

April 1, 2009

Enrollment Period

3.2 years

First QC Date

February 11, 2008

Last Update Submit

April 16, 2009

Conditions

Essential Tremor

Keywords

tremorwritingfeedingpouring

Outcome Measures

Primary Outcomes (1)

  • Performance on a 16-item tremor rating scale including degree of tremor, writing, pouring and feeding.

    12 weeks per treatment arm

Secondary Outcomes (1)

  • Assessment of adverse side effects.

    12 weeks per arm

Study Arms (2)

1

EXPERIMENTAL
Drug: levetiracetam

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

levetiracetamDRUG

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.

Also known as: keppra
1
placeboDRUG

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.

2

Eligibility Criteria

Age25 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of tremor for 5 or more years
  • No other neurological problems

You may not qualify if:

  • Prior stroke or other neurological disease, psychiatric problems
  • History of renal disease
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

Location

MeSH Terms

Conditions

Essential TremorTremor

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Steven S Schreiber, MD

    Southern California Institute for Research and Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2008

First Posted

February 21, 2008

Study Start

January 1, 2005

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

April 17, 2009

Record last verified: 2009-04

Locations

US(1)