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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Oslo University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00393614
First received: October 27, 2006
Last updated: September 22, 2009
Last verified: February 2008
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Levetiracetam Treatment of Children With Subclinical Sleep-Activated Epileptiform Activity (SSEA) - a Placebo Controlled Double-blind Cross-over-study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

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: March 2010
Estimated Primary Completion Date: March 2010 (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

Locations
Norway
Rikshospitalet-Radiumhospitalet HF
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Ann-Sofie Eriksson, MD Phd Oslo University Hospital
  More Information

No publications provided

Responsible Party: Ann-Sofie Eriksson, MD Phd, The National Centre for Epilepsy
ClinicalTrials.gov Identifier: NCT00393614     History of Changes
Other Study ID Numbers: S06080, EudraCT number 2006-000795-32, SLV 200604331
Study First Received: October 27, 2006
Last Updated: September 22, 2009
Health Authority: Norway: Norwegian Medicines Agency
Norway: The Data Inspectorate
Norway: Directorate of Health

Keywords provided by Oslo University Hospital:
CSWS, interiktal epileptiform activity

Additional relevant MeSH terms:
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013