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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:
Sponsor: Institute of Child Health

Current Primary Outcome: Effect of reduction in anti-epileptic medications on quality of life in young people with intractable epilepsy [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Identify other determinants of quality of life in this group of subjects [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: Institute of Child Health

Dates:
Date Received: March 26, 2008
Date Started: September 2008
Date Completion:
Last Updated: March 26, 2008
Last Verified: March 2008