---
title: The Impact of Reducing Overtreatment on Quality of Life in Children With Refractory Epilepsy
nct_id: NCT00647322
overall_status: UNKNOWN
phase: PHASE4
sponsor: Institute of Child Health
study_type: INTERVENTIONAL
primary_condition: Intractable Epilepsy
countries: United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00647322.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00647322"
ct_last_update_post_date: 2008-03-31
last_seen_at: "2026-05-12T07:09:03.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Impact of Reducing Overtreatment on Quality of Life in Children With Refractory Epilepsy

**NCT ID:** [NCT00647322](https://clinicaltrials.gov/study/NCT00647322)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 64
- **Lead Sponsor:** Institute of Child Health
- **Conditions:** Intractable Epilepsy
- **Start Date:** 2008-09
- **CT.gov Last Update:** 2008-03-31

## 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.

## Eligibility

- **Minimum age:** 6 Years
- **Maximum age:** 21 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

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

Exclusion Criteria:

* None
```

## Arms

- **1** (EXPERIMENTAL) — Reduction in anti-epileptic medications
- **2** (ACTIVE_COMPARATOR) — No change in medication. Unchanged treatment

## Interventions

- **Reduction of anti-epileptic medications** (OTHER) — Reduction in anti-epileptic medications
- **No drug change** (PROCEDURE) — No change in anti-epileptic treatment

## Primary Outcomes

- **Effect of reduction in anti-epileptic medications on quality of life in young people with intractable epilepsy** _(time frame: 6 months)_

## Secondary Outcomes

- **Identify other determinants of quality of life in this group of subjects** _(time frame: 6 months)_

## Locations (1)

- Neurosciences Unit, UCL Institute of Child Health, The Wolfson Centre,, London, United Kingdom

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.neurosciences unit, ucl institute of child health, the wolfson centre,|london||united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00647322.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00647322*  
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