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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Institute of Child Health.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Institute of Child Health
ClinicalTrials.gov Identifier:
NCT00647322
First received: March 26, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted

March 26, 2008
March 26, 2008
September 2008
September 2010   (final data collection date for primary outcome measure)
Effect of reduction in anti-epileptic medications on quality of life in young people with intractable epilepsy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Identify other determinants of quality of life in this group of subjects [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Impact of Reducing Overtreatment on Quality of Life in Children With Refractory Epilepsy
The Impact of Reducing Overtreatment on Quality of Life in Children With Refractory Epilepsy

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Intractable Epilepsy
  • Other: Reduction of anti-epileptic medications
    Reduction in anti-epileptic medications
  • Procedure: No drug change
    No change in anti-epileptic treatment
  • Experimental: 1
    Reduction in anti-epileptic medications
    Intervention: Other: Reduction of anti-epileptic medications
  • Active Comparator: 2
    No change in medication. Unchanged treatment
    Intervention: Procedure: No drug change
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
64
Not Provided
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Both
6 Years to 21 Years
No
Contact: Dr R Scott, Phd r.scott@ich.ucl.ac.uk
United Kingdom
 
NCT00647322
07NR07
Not Provided
R&D Office, Institute of Child Health
Institute of Child Health
Not Provided
Not Provided
Institute of Child Health
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP