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Sponsored by: |
Rikshospitalet HF |
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Information provided by: | Rikshospitalet HF |
ClinicalTrials.gov Identifier: | NCT00393614 |
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).
Condition | Intervention | Phase |
---|---|---|
Subclinical Sleep-Activated Epileptiform Activity CSWS |
Drug: levetiracetam |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Levetiracetam Treatment of Children With Subclinical Sleep-Activated Epileptiform Activity (SSEA) - a Placebo Controlled Double-Blind Cross-Over-Study |
Estimated Enrollment: | 30 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 5 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contact: Ann-Sofie Eriksson, MD Phd | 0047 6750 1000 | Ann-Sofie.Eriksson@epilepsy.no |
Norway | |
Rikshospitalet-Radiumhospitalet HF | Recruiting |
Oslo, Norway, 0027 | |
Contact: Ann-Sofie Eriksson, MD Phd +4767501000 ann-sofie.eriksson@rikshospitalet.no |
Principal Investigator: | Ann-Sofie Eriksson, MD Phd | Rikshospitalet HF |
Responsible Party: | The National Centre for Epilepsy ( Ann-Sofie Eriksson, MD Phd ) |
Study ID Numbers: | S06080, EudraCT number 2006-000795-32, SLV 200604331 |
Study First Received: | October 27, 2006 |
Last Updated: | February 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00393614 |
Health Authority: | Norway: Norwegian Medicines Agency; Norway: The Data Inspectorate; Norway: Directorate for Health and Social Affairs |
CSWS, interiktal epileptiform activity |
Etiracetam |
Nootropic Agents Therapeutic Uses Central Nervous System Agents Pharmacologic Actions Anticonvulsants |