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

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00302991
First received: March 13, 2006
Last updated: January 29, 2008
Last verified: January 2008
History of Changes
  Purpose

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 Phase
Epilepsy
 Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Quality of Life and Adverse Effects in Epilepsy Patients According to Treatment Group (EPIKA)

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Estimated Enrollment: 180
Study Start Date: March 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00302991

Locations
Spain
Barcelona, Spain
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial M. Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00302991     History of Changes
Other Study ID Numbers: N01247, EPIKA
Study First Received: March 13, 2006
Last Updated: January 29, 2008
Health Authority: Spain: Ministry of Health

Keywords provided by UCB, Inc.:
Observational
cross-sectional
health-related quality of life
 adverse effects
Baker´s AEP scale validation
epilepsy

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

ClinicalTrials.gov processed this record on May 22, 2013