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

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ClinicalTrials.gov Identifier: NCT00647322
Recruitment Status : Unknown
Verified March 2008 by Institute of Child Health.
Recruitment status was:  Not yet recruiting
First Posted : March 31, 2008
Last Update Posted : March 31, 2008
Sponsor:
Information provided by:
Institute of Child Health

Tracking Information
First Submitted Date  ICMJE March 26, 2008
First Posted Date  ICMJE March 31, 2008
Last Update Posted Date March 31, 2008
Study Start Date  ICMJE September 2008
Estimated Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2008)
Effect of reduction in anti-epileptic medications on quality of life in young people with intractable epilepsy [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2008)
Identify other determinants of quality of life in this group of subjects [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Reducing Overtreatment on Quality of Life in Children With Refractory Epilepsy
Official Title  ICMJE The Impact of Reducing Overtreatment on Quality of Life in Children With Refractory Epilepsy
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Condition  ICMJE Intractable Epilepsy
Intervention  ICMJE
  • Other: Reduction of anti-epileptic medications
    Reduction in anti-epileptic medications
  • Procedure: No drug change
    No change in anti-epileptic treatment
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 26, 2008)
64
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00647322
Other Study ID Numbers  ICMJE 07NR07
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party R&D Office, Institute of Child Health
Study Sponsor  ICMJE Institute of Child Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institute of Child Health
Verification Date March 2008

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