Levetiracetam for Benign Rolandic Epilepsy

NCT ID: NCT00181116

Last Updated: 2009-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-09-30

Brief Summary

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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.

Detailed Description

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This is a 6 month study in which children on another anticonvulsant would have EEG, language testing, and a clinic visit at baseline. They would then be rapidly transitioned off of their current anticonvulsant and onto levetiracetam (Keppra). Repeat EEG and language testing would be done after 6 months to evaluate for improvement.

Conditions

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Epilepsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Levetiracetam

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Principal Investigators

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Eric H Kossoff, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12651081 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14527502 (View on PubMed)

Other Identifiers

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05-02-18-06

Identifier Type: -

Identifier Source: org_study_id

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