Levetiracetam Treatment of Children With Subclinical Sleep-Activated Epileptiform Activity (SSEA) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 27, 2006

Last Updated Date

February 29, 2008

Start Date ^†

May 2007

Current Primary Outcome Measures ^†

24 hour EEG [ Time Frame: End of the study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00393614 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Neuro-psychological testing, [ Time Frame: End of the study ] [ Designated as safety issue: No ]
Health related quality of life [ Time Frame: End of the study ] [ Designated as safety issue: No ]
Behavioral problems [ Time Frame: End of the study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Neuro-phsycolocial testing,
Health related quality of life
Behavioral problems

Descriptive Information

Brief Title ^†

Levetiracetam Treatment of Children With Subclinical Sleep-Activated Epileptiform Activity (SSEA)

Official Title ^†

Levetiracetam Treatment of Children With Subclinical Sleep-Activated Epileptiform Activity (SSEA) - a Placebo Controlled Double-Blind Cross-Over-Study

Brief Summary

In clinical practice at the National centre for epilepsy (SSE) in Norway we see many children who have subclinical epileptiform activity in EEG that increases substantially during slow wave sleep (SSEA; subclinical sleep-activated epileptiform activity). They may or may not have seizures. Hence, according to the definition some children with SSEA do not suffer from epilepsy because they do not experience seizures. Many of these children have symptoms such as: attention deficit hyperactivity disorders (AD/HD), dyslectic problems, sleep problems, tantrums or autistic symptoms . We hypothesize that this subclinical epileptiform activity during slow sleep may act negatively on cognitive functions, language and behaviour in some children; even when the spike-wave discharges are less frequent than in CSWS (continuous spike-waves during slow sleep).

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study

Condition ^†

Subclinical Sleep-Activated Epileptiform Activity
CSWS

Intervention ^†

Drug: levetiracetam

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

December 2009

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria: - Children 5-10 years - IQ > 50

Gender

Both

Ages

5 Years to 10 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Ann-Sofie Eriksson, MD Phd

0047 6750 1000

Ann-Sofie.Eriksson@epilepsy.no

Location Countries ^†

Norway

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00393614

Responsible Party

Ann-Sofie Eriksson, MD Phd, The National Centre for Epilepsy

Secondary IDs ^††

EudraCT number 2006-000795-32, SLV 200604331

Study Sponsor ^†

Rikshospitalet HF

Collaborators ^††

Investigators ^†

Principal Investigator:

Ann-Sofie Eriksson, MD Phd

Rikshospitalet HF

Information Provided By

Rikshospitalet HF

Verification Date

February 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.