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Clinical Trials/NCT00647322
NCT00647322
Unknown
Phase 4

The Impact of Reducing Overtreatment on Quality of Life in Children With Refractory Epilepsy

Institute of Child Health1 site in 1 country64 target enrollmentSeptember 2008

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Intractable Epilepsy
Sponsor
Institute of Child Health
Enrollment
64
Locations
1
Primary Endpoint
Effect of reduction in anti-epileptic medications on quality of life in young people with intractable epilepsy
Last Updated
18 years ago

Overview

Brief Summary

The primary aim of the study is to determine the effect of reducing the number and/or dose of anti epileptic drugs on an individual's quality of life and seizure control in people with difficult to control epilepsy and who are on polytherapy.

This is a randomised trial so children will be divided into two groups, with reduction of anti epileptic drugs in the first group (withdrawal group) and no change to their medications in the second (control group). Irrespective of the group the child is assigned to (withdrawal group or control group), we will ask parents to complete several questionnaires on 2 occasions: the first time will be immediately after the child enters the study (i.e. baseline assessment), and a second and last one will be 6 months after entering the study (i.e. follow-up assessment). These questionnaires aim to "quantify" aspects related with quality of life, AED side effects, seizure severity, and behaviour.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
September 2010
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Young people aged 6-21 years with intractable epilepsy receiving antiepileptic drug polytherapy

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Effect of reduction in anti-epileptic medications on quality of life in young people with intractable epilepsy

Time Frame: 6 months

Secondary Outcomes

  • Identify other determinants of quality of life in this group of subjects(6 months)

Study Sites (1)

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