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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. The completion date has passed and the status has not been verified in more than two years.
Verified March 2008 by Institute of Child Health.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00647322
First Posted: March 31, 2008
Last Update Posted: March 31, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Institute of Child Health
  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 (Investigator)
Official Title: The Impact of Reducing Overtreatment on Quality of Life in Children With Refractory Epilepsy

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Identify other determinants of quality of life in this group of subjects [ Time Frame: 6 months ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: R&D Office, Institute of Child Health
ClinicalTrials.gov Identifier: NCT00647322     History of Changes
Other Study ID Numbers: 07NR07
First Submitted: March 26, 2008
First Posted: March 31, 2008
Last Update Posted: March 31, 2008
Last Verified: March 2008

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

Additional relevant MeSH terms:
Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anticonvulsants