Epilepsy, PartialNCT01332539
An Observational Study to Assess the Burden of Drug-resistant Partial Epilepsy in Italy
An observational study of Epilepsy, Partial, run by GlaxoSmithKline.
Trial summary
observational, non-interventional study in 120 patients with drug-resistant partial epilepsy, comprising two phases: a 3-month retrospective and a 6-month prospective. As control group, 120 patients with controlled partial epilepsy will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Partial
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Nov 2012
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient with partial epilepsy
Who may be able to join
- Outpatients
- Diagnosis of partial epilepsy, defined as active, drug-resistant in accordance to the 2010 ILAE (International League Against Epilepsy) definition and actually taking an add-on therapeutic regimen.
- Able and willing to give the written informed consent (to be obtained before any study assessment)
- For each drug-resistant patient, will be enrolled a patient with the same diagnosis and actually taking an add-on therapy but with controlled epilepsy according to the 2010 ILAE definition.
Who cannot join
- Patient currently included in a clinical trial for an AED (Anti-Epileptic Drug)
- Hospital record data on epilepsy not available in the Investigator's files
- Patient unable to fill in self-questionnaires (quality of life instrument)
- Patient currently hospitalized
- Patient who, according to the Investigator's judgment, is not able to follow the study procedures
About this study
observational, non-interventional study in 120 patients with drug-resistant partial epilepsy, comprising two phases: a 3-month retrospective and a 6-month prospective. As control group, 120 patients with controlled partial epilepsy will be enrolled. The objective of the study is to describe the burden of illness in this epileptic population both in terms of costs and of quality of life. Costs and quality of life will be also compared between the two populations.
Read the detailed description
observational, non-interventional study in 120 patients with drug-resistant partial epilepsy, comprising two phases: a 3-month retrospective and a 6-month prospective.
- Conditions
- Epilepsy, Partial
- Being tested
- no intervention
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
Also called non-interventional study
non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| drug-resistant partial epilepsy | Not described Receives: Other: no intervention | |
| controlled partial epilepsy | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
total cost (direct and indirect) per patient per year of drug-resistant partial patients collected in the retrospective and in the prospective phase
Measured: 9 months: a 3-month retrospective and a 6-month prospective.
Secondary outcomes (3)
The primary endpoint is the total cost (direct and indirect) per patient per year of controlled patients collected in the retrospective and in the prospective phase.
Measured: 9 months. a 3-month retrospective and a 6-month prospective.
the difference between the group of drug-resistant patients and the control group as regards each single resource consumptions and the direct and indirect costs (single and total)
Measured: 9 months: a 3-month retrospective and a 6-month prospective.
The comparison of the seven multi-item scores and the overall score of QOLIE-31 (Quality of life in Epilepsy -31 items) questionnaire between the two patients groups
Measured: questionnaire administerd at visit 1 only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, PartialStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332539
- Sponsor's protocol ID
- 114872
- Status last verified
- Apr 2013
- First submitted
- 7 Apr 2011
- Last updated
- 27 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Assess the Burden of Drug-resistant Partial Epilepsy in Italy
- ClinicalTrials.gov ID
- NCT01332539
- Acronym / sponsor ID
- 114872
- Conditions
- Epilepsy, Partial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 11 Apr 2011 (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.
observational, non-interventional study in 120 patients with drug-resistant partial epilepsy, comprising two phases: a 3-month retrospective and a 6-month prospective. As control group, 120 patients with controlled partial epilepsy will be enrolled. The objective of the study is to describe the burden of illness in this epileptic population both in terms of costs and of quality of life. Costs and quality of life will be also compared between the two populations.
Detailed description
observational, non-interventional study in 120 patients with drug-resistant partial epilepsy, comprising two phases: a 3-month retrospective and a 6-month prospective.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drug-resistant partial epilepsy | – | Other: no intervention |
| controlled partial epilepsy | – | Other: no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient with partial epilepsy
Key inclusion criteria (4 listed)
- Outpatients
- Diagnosis of partial epilepsy, defined as active, drug-resistant in accordance to the 2010 ILAE (International League Against Epilepsy) definition and actually taking an add-on therapeutic regimen.
- Able and willing to give the written informed consent (to be obtained before any study assessment)
- For each drug-resistant patient, will be enrolled a patient with the same diagnosis and actually taking an add-on therapy but with controlled epilepsy according to the 2010 ILAE definition.
Key exclusion criteria (5 listed)
- Patient currently included in a clinical trial for an AED (Anti-Epileptic Drug)
- Hospital record data on epilepsy not available in the Investigator's files
- Patient unable to fill in self-questionnaires (quality of life instrument)
- Patient currently hospitalized
- Patient who, according to the Investigator's judgment, is not able to follow the study procedures
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 |
|---|---|---|
| no interventionAlso: non-interventional studynon-interventional study | Other | controlled partial epilepsy, drug-resistant partial epilepsy |
Primary outcome
total cost (direct and indirect) per patient per year of drug-resistant partial patients collected in the retrospective and in the prospective phase
Time frame: 9 months: a 3-month retrospective and a 6-month prospective.
3 secondary outcomes
The primary endpoint is the total cost (direct and indirect) per patient per year of controlled patients collected in the retrospective and in the prospective phase.
Time frame: 9 months. a 3-month retrospective and a 6-month prospective.
the difference between the group of drug-resistant patients and the control group as regards each single resource consumptions and the direct and indirect costs (single and total)
Time frame: 9 months: a 3-month retrospective and a 6-month prospective.
The comparison of the seven multi-item scores and the overall score of QOLIE-31 (Quality of life in Epilepsy -31 items) questionnaire between the two patients groups
Time frame: questionnaire administerd at visit 1 only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, Partial, run by GlaxoSmithKline.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total cost (direct and indirect) per patient per year of drug-resistant partial patients collected in the retrospective and in the prospective phase (time frame: 9 months: a 3-month retrospective and a 6-month prospective.). 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 27 May 2013.