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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
  Purpose

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.


Condition Intervention Phase
Intractable Epilepsy
 Other: Reduction of anti-epileptic medications
Procedure: No drug change
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Official Title: The Impact of Reducing Overtreatment on Quality of Life in Children With Refractory Epilepsy

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Further study details as provided by Institute of Child Health:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Identify other determinants of quality of life in this group of subjects [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: September 2008
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Reduction in anti-epileptic medications
 Other: Reduction of anti-epileptic medications
Reduction in anti-epileptic medications
Active Comparator: 2
No change in medication. Unchanged treatment
 Procedure: No drug change
No change in anti-epileptic treatment

  Eligibility

Ages Eligible for Study:   6 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647322

Contacts
Contact: Dr R Scott, Phd r.scott@ich.ucl.ac.uk

Locations
United Kingdom
Neurosciences Unit, UCL Institute of Child Health, The Wolfson Centre, Not yet recruiting
London, United Kingdom, WC1N 1EH
Contact: Rod C Scott, Phd         r.scott@ich.ucl.ac.uk    
Principal Investigator: Rod C Scott, Phd            
Sponsors and Collaborators
Institute of Child Health
  More Information

No publications provided

Responsible Party: R&D Office, Institute of Child Health
ClinicalTrials.gov Identifier: NCT00647322     History of Changes
Other Study ID Numbers: 07NR07
Study First Received: March 26, 2008
Last Updated: March 26, 2008
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Institute of Child Health:
Intractable epilepsy, Drug Reduction, Antiepileptic medication

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013