Overview

This trial is active, not recruiting.

Conditions subclinical sleep-activated epileptiform activity, csws
Treatment levetiracetam
Phase phase 4
Sponsor Oslo University Hospital
Start date May 2007
End date March 2010
Trial size 30 participants
Trial identifier NCT00393614, EudraCT number 2006-000795-32, S06080, SLV 200604331

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (caregiver, investigator)
Primary purpose treatment

Primary Outcomes

Measure
24 hour EEG
time frame: End of the study

Secondary Outcomes

Measure
Neuro-psychological testing,
time frame: End of the study
Health related quality of life
time frame: End of the study
Behavioral problems
time frame: End of the study

Eligibility Criteria

Male or female participants from 5 years up to 10 years old.

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

Additional Information

Official title Levetiracetam Treatment of Children With Subclinical Sleep-Activated Epileptiform Activity (SSEA) - a Placebo Controlled Double-blind Cross-over-study
Principal investigator Ann-Sofie Eriksson, MD Phd
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by Oslo University Hospital.