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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00647322
Enrollment
64
Registered
2008-03-31
Start date
2008-09-30
Completion date
Unknown
Last updated
2008-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intractable Epilepsy

Keywords

Intractable epilepsy, Drug Reduction, Antiepileptic medication

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.

Interventions

OTHERReduction of anti-epileptic medications

Reduction in anti-epileptic medications

PROCEDURENo drug change

No change in anti-epileptic treatment

Sponsors

Institute of Child Health
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
6 Years to 21 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
Effect of reduction in anti-epileptic medications on quality of life in young people with intractable epilepsy6 months

Secondary

MeasureTime frame
Identify other determinants of quality of life in this group of subjects6 months

Countries

United Kingdom

Contacts

Primary ContactDr R Scott, Phd
r.scott@ich.ucl.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026