Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

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


Further study details as provided by UCB Pharma:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Spain
Barcelona, Spain
Sponsors and Collaborators
UCB Pharma
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 Pharma:
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 November 25, 2014