The Impact of Reducing Overtreatment on Quality of Life in Children With Refractory Epilepsy
NCT ID: NCT00647322
Last Updated: 2008-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
64 participants
INTERVENTIONAL
2008-09-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SINGLE
Study Groups
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1
Reduction in anti-epileptic medications
Reduction of anti-epileptic medications
Reduction in anti-epileptic medications
2
No change in medication. Unchanged treatment
No drug change
No change in anti-epileptic treatment
Interventions
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Reduction of anti-epileptic medications
Reduction in anti-epileptic medications
No drug change
No change in anti-epileptic treatment
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Years
21 Years
ALL
No
Sponsors
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Institute of Child Health
OTHER
Responsible Party
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Institute of Child Health
Locations
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Neurosciences Unit, UCL Institute of Child Health, The Wolfson Centre,
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Rod C Scott, Phd
Role: primary
Other Identifiers
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07NR07
Identifier Type: -
Identifier Source: org_study_id