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

Phase 4

• Conditions: Intractable Epilepsy
• Interventions: Other: Reduction of anti-epileptic medications; Procedure: No drug change

• Registration Number: NCT00647322
• Lead Sponsor: Institute of Child Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-03
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-26
• Last Update Submitted: 2008-03-26
• Study First Posted: 2008-03-31
• Last Update Posted: 2008-03-31
• Study Start: 2008-09
• Primary Completion: 2010-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Reduction of anti-epileptic medications	Reduction in anti-epileptic medications
2	No drug change	No change in medication. Unchanged treatment

Primary Outcome Measures

Name	Time	Method
Effect of reduction in anti-epileptic medications on quality of life in young people with intractable epilepsy	6 months

Secondary Outcome Measures

Name	Time	Method
Identify other determinants of quality of life in this group of subjects	6 months

Trial Locations

Locations (1)

Neurosciences Unit, UCL Institute of Child Health, The Wolfson Centre,; 🇬🇧 London, United Kingdom