The Impact of Reducing Overtreatment on Quality of Life in Children With Refractory Epilepsy
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 31, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedMarch 31, 2008
March 1, 2008
2 years
March 26, 2008
March 26, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of reduction in anti-epileptic medications on quality of life in young people with intractable epilepsy
6 months
Secondary Outcomes (1)
Identify other determinants of quality of life in this group of subjects
6 months
Study Arms (2)
1
EXPERIMENTALReduction in anti-epileptic medications
2
ACTIVE COMPARATORNo change in medication. Unchanged treatment
Interventions
Eligibility Criteria
You may qualify if:
- Young people aged 6-21 years with intractable epilepsy receiving antiepileptic drug polytherapy
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neurosciences Unit, UCL Institute of Child Health, The Wolfson Centre,
London, WC1N 1EH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 26, 2008
First Posted
March 31, 2008
Study Start
September 1, 2008
Primary Completion
September 1, 2010
Last Updated
March 31, 2008
Record last verified: 2008-03