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Levetiracetam Treatment of Children With Subclinical Sleep-Activated Epileptiform Activity (SSEA)
This study is currently recruiting participants.
Verified by Rikshospitalet HF, February 2008
Sponsored by: Rikshospitalet HF
Information provided by: Rikshospitalet HF
ClinicalTrials.gov Identifier: NCT00393614
  Purpose

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

MedlinePlus related topics: Epilepsy
Drug Information available for: Levetiracetam
U.S. FDA Resources
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

Further study details as provided by Rikshospitalet HF:

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

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 ]

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)
Intervention Details:
    Drug: levetiracetam
    20 mg pr. kg a day
  Eligibility

Ages Eligible for Study:   5 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children 5-10 years
  • IQ > 50
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393614

Contacts
Contact: Ann-Sofie Eriksson, MD Phd 0047 6750 1000 Ann-Sofie.Eriksson@epilepsy.no

Locations
Norway
Rikshospitalet-Radiumhospitalet HF Recruiting
Oslo, Norway, 0027
Contact: Ann-Sofie Eriksson, MD Phd     +4767501000     ann-sofie.eriksson@rikshospitalet.no    
Sponsors and Collaborators
Rikshospitalet HF
Investigators
Principal Investigator: Ann-Sofie Eriksson, MD Phd Rikshospitalet HF
  More Information

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

Keywords provided by Rikshospitalet HF:
CSWS, interiktal epileptiform activity

Study placed in the following topic categories:
Etiracetam

Additional relevant MeSH terms:
Nootropic Agents
Therapeutic Uses
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 14, 2009