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

Institute of Child Health

Status and phase: Unknown; Phase 4

Conditions: Intractable Epilepsy

Treatments: Other: Reduction of anti-epileptic medications; Procedure: No drug change

Study type: Interventional

Funder types: Other

Identifiers

NCT00647322

07NR07

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 6 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

64 participants in 2 patient groups

1

Experimental group

Description:

Reduction in anti-epileptic medications

Treatment:

Other: Reduction of anti-epileptic medications

2

Active Comparator group

Description:

No change in medication. Unchanged treatment

Treatment:

Procedure: No drug change