Intractable EpilepsyPhase 4NCT00647322
The Impact of Reducing Overtreatment on Quality of Life in Children With Refractory Epilepsy
A Phase 4 study testing Reduction of anti-epileptic medications and No drug change in people with Intractable Epilepsy, run by Institute of Child Health at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Intractable Epilepsy
- What is being tested?
- Reduction of anti-epileptic medications and No drug change
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2008to Sep 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Young people aged 6-21 years with intractable epilepsy receiving antiepileptic drug polytherapy
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Dr R Scott, Phd contact
United Kingdom1 site
Neurosciences Unit, UCL Institute of Child Health, The Wolfson Centre,
London, WC1N 1EH
Rod C Scott, Phd, r.scott@ich.ucl.ac.uk
Rod C Scott, Phd
About this study
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.
- Conditions
- Intractable Epilepsy
- Being tested
- Reduction of anti-epileptic medications, No drug change
- Keywords
- Intractable epilepsy, Drug Reduction, Antiepileptic medication
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction of anti-epileptic medicationsOther
Reduction in anti-epileptic medications
No drug changeProcedure or surgery
No change in anti-epileptic treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Reduction in anti-epileptic medications Receives: Other: Reduction of anti-epileptic medications |
| 2 | Active comparator | No change in medication. Unchanged treatment Receives: Procedure: No drug change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of reduction in anti-epileptic medications on quality of life in young people with intractable epilepsy
Measured: 6 months
Secondary outcomes (1)
Identify other determinants of quality of life in this group of subjects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intractable EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647322
- Sponsor's protocol ID
- 07NR07
- Status last verified
- Mar 2008
- First submitted
- 26 Mar 2008
- Last updated
- 31 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Reducing Overtreatment on Quality of Life in Children With Refractory Epilepsy
- ClinicalTrials.gov ID
- NCT00647322
- Acronym / sponsor ID
- 07NR07
- Conditions
- Intractable Epilepsy
- Keywords
- Intractable epilepsy, Drug Reduction, Antiepileptic medication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (estimated)
- First posted
- 31 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Reduction of anti-epileptic medicationsReduction in anti-epileptic medications |
| 2 | Active comparator | Procedure: No drug changeNo change in medication. Unchanged treatment |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Young people aged 6-21 years with intractable epilepsy receiving antiepileptic drug polytherapy
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduction of anti-epileptic medicationsReduction in anti-epileptic medications | Other | 1 |
| No drug changeNo change in anti-epileptic treatment | Procedure or surgery | 2 |
Primary outcome
Effect of reduction in anti-epileptic medications on quality of life in young people with intractable epilepsy
Time frame: 6 months
1 secondary outcome
Identify other determinants of quality of life in this group of subjects
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr R Scott, Phd contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reduction of anti-epileptic medications and No drug change in people with Intractable Epilepsy, run by Institute of Child Health at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr R Scott, Phd (r.scott@ich.ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of reduction in anti-epileptic medications on quality of life in young people with intractable epilepsy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2008.