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

Intractable Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00647322
• Other study ID #: 07NR07
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 26, 2008
• Last updated: March 26, 2008
• Start date: September 2008

Study information

• Verified date: March 2008
• Source: Institute of Child Health
• Contact: Dr R Scott, Phd
• Email: r.scott[@]ich.ucl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 21 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Epilepsy
• Intractable Epilepsy

Intervention

Other:
• Reduction of anti-epileptic medications
Reduction in anti-epileptic medications

Procedure:
• No drug change
No change in anti-epileptic treatment

Locations

Country	Name	City	State
United Kingdom	Neurosciences Unit, UCL Institute of Child Health, The Wolfson Centre,	London

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Child Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of reduction in anti-epileptic medications on quality of life in young people with intractable epilepsy		6 months	No
Secondary	Identify other determinants of quality of life in this group of subjects		6 months	No