EpilepsyNCT00264680
Spanish Validation Of Quality of Life Questionnaire (QOLIE-10) For Epilepsy
An observational study of Epilepsy, run by GlaxoSmithKline.
Trial summary
Validation of qolie-10, an epilepsy specific quality of life questionnaire in patients treated with lamotrigine or valproic acid. Comparison of quality of life of epileptic patients treated with lamotrigine or valproic acid. Determination and assessment of the comparative safety of lamotrigine or valproic acid. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- lamotrigine and valproic acid
- How many people
- 333 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2003to 1 Mar 2006
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of epilepsy and normal neurological examination.
- Patients receiving lamotrigine or valproic acid at stable doses in monotherapy initiated 2 -4 months before.
Who cannot join
- Pregnant or lactating women.
- Previous treatment with lamotrigine or valproic acid.
- Secondary epilepsy.
About this study
Official title: Validation Of Qolie-10 For Epilepsy, Comparison Of Quality Of Life In Patients Treated With Lamotrigine Or Valproic Acid
Validation of qolie-10, an epilepsy specific quality of life questionnaire in patients treated with lamotrigine or valproic acid. Comparison of quality of life of epileptic patients treated with lamotrigine or valproic acid. Determination and assessment of the comparative safety of lamotrigine or valproic acid. Assessment and comparison of body image perception in women treated with lamotrigine or valproic acid.
- Conditions
- Epilepsy
- Being tested
- lamotrigine, valproic acid
- Keywords
- quality of life, qolie-10, epilepsy, lamotrigine, Validation of questionnaire
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lamotrigineDrug
valproic acidDrug
Also called lamotrigine
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Validity, feasibility and reliability of qolie-10 (test-retest, internal consistency) 2. Qolie-10 scores between groups 3. Body image scores between groups
Secondary outcomes (1)
Adverse Events: nature and number between groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
- Study start1 Oct 2003
- Primary completion1 Mar 2006
- Study completion1 Mar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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
- Enrolment
- 333 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
- NCT00264680
- Sponsor's protocol ID
- LAM-2003-01
- Status last verified
- Oct 2017
- First submitted
- 9 Dec 2005
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Of Qolie-10 For Epilepsy, Comparison Of Quality Of Life In Patients Treated With Lamotrigine Or Valproic Acid
- ClinicalTrials.gov ID
- NCT00264680
- Acronym / sponsor ID
- LAM-2003-01
- Conditions
- Epilepsy
- Keywords
- quality of life, qolie-10, epilepsy, lamotrigine, Validation of questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2003 (actual)
- Primary completion
- 1 Mar 2006 (actual)
- Study completion
- 1 Mar 2006 (actual)
- First posted
- 13 Dec 2005 (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.
Validation of qolie-10, an epilepsy specific quality of life questionnaire in patients treated with lamotrigine or valproic acid. Comparison of quality of life of epileptic patients treated with lamotrigine or valproic acid. Determination and assessment of the comparative safety of lamotrigine or valproic acid. Assessment and comparison of body image perception in women treated with lamotrigine or valproic acid.
Study design
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of epilepsy and normal neurological examination.
- Patients receiving lamotrigine or valproic acid at stable doses in monotherapy initiated 2 -4 months before.
Key exclusion criteria (3 listed)
- Pregnant or lactating women.
- Previous treatment with lamotrigine or valproic acid.
- Secondary epilepsy.
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 |
|---|---|---|
| lamotrigine | Drug | – |
| valproic acidAlso: lamotrigine | Drug | – |
Primary outcome
1. Validity, feasibility and reliability of qolie-10 (test-retest, internal consistency) 2. Qolie-10 scores between groups 3. Body image scores between groups
1 secondary outcome
Adverse Events: nature and number between groups
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 30 Oct 2017.
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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, 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 2 inclusion and 3 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 30 Oct 2017. 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?
1. Validity, feasibility and reliability of qolie-10 (test-retest, internal consistency) 2. Qolie-10 scores between groups 3. Body image scores between groups. 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 30 Oct 2017.