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

CSWS Clinical Trial

Official title:

Levetiracetam Treatment of Children With Subclinical Sleep-Activated Epileptiform Activity (SSEA) - a Placebo Controlled Double-blind Cross-over-study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00393614
• Other study ID #: S06080
• Secondary ID: EudraCT number 2
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 27, 2006
• Last updated: September 22, 2009
• Start date: May 2007
• Est. completion date: March 2010

Study information

• Verified date: February 2008
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway: The Data InspectorateNorway: Directorate of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 10 Years

Eligibility

Inclusion Criteria:

• Children 5-10 years

• IQ > 50

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• CSWS
• Subclinical Sleep-Activated Epileptiform Activity

Intervention

Drug:
• levetiracetam
20 mg pr. kg a day

Locations

Country	Name	City	State
Norway	Rikshospitalet-Radiumhospitalet HF	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour EEG		End of the study	No
Secondary	Neuro-psychological testing,		End of the study	No
Secondary	Health related quality of life		End of the study	No
Secondary	Behavioral problems		End of the study	No