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

NCT00647322 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2008-03-31

No results posted yet for this study

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

OTHER

Reduction of anti-epileptic medications

Reduction in anti-epileptic medications

PROCEDURE

No drug change

No change in anti-epileptic treatment

Sponsors & Collaborators

  • Institute of Child Health

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00647322 on ClinicalTrials.gov