NCT00181116

Brief Summary

This study is designed to test if the language problems commonly seen in children with benign rolandic epilepsy would improve by switching anticonvulsants to levetiracetam.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2005

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

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

March 27, 2009

Status Verified

March 1, 2009

First QC Date

September 10, 2005

Last Update Submit

March 26, 2009

Conditions

Epilepsy

Keywords

EpilepsyBenign rolandicLevetiracetam

Outcome Measures

Primary Outcomes (1)

  • Language improvement

Secondary Outcomes (1)

  • Seizure control

Interventions

LevetiracetamDRUG

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Ages 6-12
  • Benign rolandic epilepsy
  • Language difficulties as reported by parents or teachers
  • On another anticonvulsant other than levetiracetam

You may not qualify if:

  • Prior use of levetiracetam
  • On 2 or more anticonvulsants
  • Language problems prior to epilepsy
  • Another seizure disorder
  • Status epilepticus within the past 6 months
  • Significant psychiatric disease
  • Progressive neurologic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

  • Bello-Espinosa LE, Roberts SL. Levetiracetam for benign epilepsy of childhood with centrotemporal spikes-three cases. Seizure. 2003 Apr;12(3):157-9. doi: 10.1016/s1059-1311(03)00004-9.

    PMID: 12651081BACKGROUND

  • Kossoff EH, Boatman D, Freeman JM. Landau-Kleffner syndrome responsive to levetiracetam. Epilepsy Behav. 2003 Oct;4(5):571-5. doi: 10.1016/s1525-5050(03)00171-9.

    PMID: 14527502BACKGROUND

MeSH Terms

Conditions

Epilepsy

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Eric H Kossoff, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 16, 2005

Study Start

March 1, 2005

Study Completion

September 1, 2006

Last Updated

March 27, 2009

Record last verified: 2009-03

Locations

US(1)