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

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ClinicalTrials.gov Identifier: NCT00393614
Recruitment Status : Unknown
Verified February 2008 by Oslo University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 30, 2006
Last Update Posted : September 23, 2009
Sponsor:
Information provided by:
Oslo University Hospital

Brief 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).

Condition or disease Intervention/treatment Phase
Subclinical Sleep-Activated Epileptiform Activity CSWS Drug: levetiracetam Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Care Provider, 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
Study Start Date : May 2007
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. 24 hour EEG [ Time Frame: End of the study ]

Secondary Outcome Measures :
  1. Neuro-psychological testing, [ Time Frame: End of the study ]
  2. Health related quality of life [ Time Frame: End of the study ]
  3. Behavioral problems [ Time Frame: End of the study ]


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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children 5-10 years
  • IQ > 50

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393614


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

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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
First Posted: October 30, 2006    Key Record Dates
Last Update Posted: September 23, 2009
Last Verified: February 2008

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

Additional relevant MeSH terms:
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Levetiracetam
Anticonvulsants
Nootropic Agents