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Quality of Life and Adverse Effects in Epilepsy Patients (EPIKA)

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ClinicalTrials.gov Identifier: NCT00302991
Recruitment Status : Completed
First Posted : March 15, 2006
Last Update Posted : January 30, 2008
Information provided by:
UCB Pharma

Brief Summary:
Observational, multicentre, epidemiological study to determine the HRQOL of patients with epilepsy according to treatment sub-group and to validate the Spanish version of the Adverse Events Profile, produced by G. Baker et al. Three treatment groups will be examined: patients receiving only a new anti-epilepsy drug (AED), patients receiving a "classic" AED; patients receiving combination therapy.

Condition or disease Phase
Epilepsy Phase 4

Study Type : Observational
Estimated Enrollment : 180 participants
Time Perspective: Prospective
Official Title: Quality of Life and Adverse Effects in Epilepsy Patients According to Treatment Group (EPIKA)
Study Start Date : March 2006
Primary Completion Date : October 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Epileptic adult patients treated at a stable dose with one or more AEDs for ≥ 3 months

Exclusion Criteria:

  • Symptomatic epilepsy due to malignant brain tumour or progressive brain disease.
  • Confirmed diagnosis of a concomitant chronic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00302991

Barcelona, Spain
Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial M. Call Center +1 877 822 9493 (UCB)

Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00302991     History of Changes
Other Study ID Numbers: N01247
First Posted: March 15, 2006    Key Record Dates
Last Update Posted: January 30, 2008
Last Verified: January 2008

Keywords provided by UCB Pharma:
health-related quality of life
adverse effects
Baker´s AEP scale validation

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases