NCT00393614

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 30, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

September 23, 2009

Status Verified

February 1, 2008

Enrollment Period

2.8 years

First QC Date

October 27, 2006

Last Update Submit

September 22, 2009

Conditions

Subclinical Sleep-Activated Epileptiform ActivityCSWS

Keywords

CSWS, interiktal epileptiform activity

Outcome Measures

Primary Outcomes (1)

  • 24 hour EEG

    End of the study

Secondary Outcomes (3)

  • Neuro-psychological testing,

    End of the study

  • Health related quality of life

    End of the study

  • Behavioral problems

    End of the study

Interventions

levetiracetamDRUG

20 mg pr. kg a day

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 5-10 years
  • IQ \> 50

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet-Radiumhospitalet HF

Oslo, 0027, Norway

Location

MeSH Terms

Interventions

Levetiracetam

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ann-Sofie Eriksson, MD Phd

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2006

First Posted

October 30, 2006

Study Start

May 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

September 23, 2009

Record last verified: 2008-02

Locations

NO(1)