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

NCT ID: NCT00393614

Last Updated: 2009-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Subclinical Sleep-Activated Epileptiform Activity CSWS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Interventions

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levetiracetam

20 mg pr. kg a day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Children 5-10 years
* IQ \> 50
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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The National Centre for Epilepsy

Principal Investigators

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Ann-Sofie Eriksson, MD Phd

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Rikshospitalet-Radiumhospitalet HF

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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EudraCT number 2006-000795-32

Identifier Type: -

Identifier Source: secondary_id

SLV 200604331

Identifier Type: -

Identifier Source: secondary_id

S06080

Identifier Type: -

Identifier Source: org_study_id

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