NCT00647322

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Institute of Child Health · Academic / Other
• Sex: All
• Age: 6 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intractable Epilepsy

Interventions

Type	Name	Description
OTHER	Reduction of anti-epileptic medications	Reduction in anti-epileptic medications
PROCEDURE	No drug change	No change in anti-epileptic treatment

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-09-01
• First posted: 2008-03-31
• Last updated: 2008-03-31

Locations

1 site across 1 country: United Kingdom