Last updated: 11/03/2018 20:01:27

Latin America Observational Study on Epilepsy PatientsLIVE

GSK study ID
117084
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Latin America Observational Study on Epilepsy Patients
Trial description: This is a multicenter, multi-country, observational study on Latin America Epilepsy patients. The design employs a mixed retrospective/cross-sectional design, and is comprised of two related parts: Part 1, which involves three years retrospective medical chart review; and Part 2, a questionnaire conducted during a pre-scheduled medical visit in a sub-sample of patients whose charts were reviewed in Part 1.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Incidence of overall events

Timeframe: Collected when available during the study Follow-up period

Number of seizures per month

Timeframe: Collected when available during the study Follow-up period

Quality of life

Timeframe: Once

Incidence of seizure-related event

Timeframe: Collected when available during the study Follow-up period

Type of seizure

Timeframe: Collected when available during the study Follow-up period

Use of healthcare resources

Timeframe: Collected when available during the study Follow-up period

Secondary outcomes:

Access to treatment

Timeframe: Once

Previous non-pharmacologic treatments

Timeframe: Collected when available during the study Follow-up period

Prevalence of psychiatric co-morbidities:

Timeframe: Collected when available during the study Follow-up period

Impact on work and school

Timeframe: Once

Past medication used

Timeframe: Collected when available during the study Follow-up period

Therapeutic Changes

Timeframe: Collected when available during the study Follow-up period

Type of access to treatment

Timeframe: Once

Employment status

Timeframe: Once

Prevalence of depression

Timeframe: Once

Utilization of AEDs (Antiepileptic Drug)

Timeframe: Once

First Medication used

Timeframe: Once

Medication adherence

Timeframe: Once

Medication used at the index date and Current Medication used at each visit during the follow-up period

Timeframe: Collected when available during the study Follow-up period

Reasons for changing the medication

Timeframe: Reason the therapeutic scheme has changed, eg: lack of efficacy, AE, interactions with other medication, cost, medication compliance, medication availability, others.

Interventions:
Not applicable
Enrollment:
118
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Epilepsy
Product
lamotrigine, levetiracetam, retigabine
Collaborators
Not applicable
Study date(s)
September 2013 to February 2015
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
  • Part 1 :
  • Inclusion Criteria:
Inclusion and exclusion criteria
Inclusion criteria:
  • Part 1 : Inclusion Criteria: 1. Age ≥18 years old at time of first ambulatory admission 2. Any reference to an epilepsy diagnosis documented in the medical chart 3. Date of admission at the reference center between 01/01/2008 and 12/31/2009 4. Epilepsy treatment already started and documented in the medical chart during the inclusion period (01/01/2008 to 12/31/2009) 5. Recent medical diagnosis of epilepsy (patients with first medical diagnosis of epilepsy by a specialist during the year previous to the index date OR Refractory epilepsy patients (patients with a medical diagnosis of refractory epilepsy documented in their medical charts OR Patients with failure of at least two first-line AEDs to control seizures plus at least one seizure per year OR Patients who have already been submitted to an epilepsy surgery) 6. Patients who agree to participate in the study by signing an ICF OR Patients who meet at least one criteria for a special authorization from the ethics committees Exclusion Criteria: 1. Diagnosis of epilepsy could not be determined without doubt 2. Seizures occurring only during pregnancy or associated only to alcohol and/or drug withdrawal 3. Suspicion of pregnancy flagged on the medical record at the time of the inclusion 4. Nonepileptic paroxysmal disorders 5. Presence of a progressive neurological condition 6. Patients with severe heart, liver or kidney diseases, or severe hypertension or severe diabetes 7. History of status epilepticus only 8. Patient is unable or unwilling to comply with study assessments 9. Any other reason the investigator deems the patient to be unsuitable for the study 10. Participation in a clinical trial any time during the study period Part 2: Inclusion Criteria 1. Patients who participated in Part 1 and are still being followed at the site 2. Patients who agree to participate in Part 2 by signing an ICF, including the administration of questionnaires in addition to medical chart data abstraction

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2015-28-02

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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