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

This study has been completed.

First Received: March 13, 2006 Last Updated: January 29, 2008 History of Changes

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00302991

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 IV

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

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

U.S. FDA Resources

Further study details as provided by UCB:

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

Investigators

Study Director:

UCB Clinical Trial M. Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

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

Keywords provided by UCB:

Observational
cross-sectional
health-related quality of life

adverse effects
Baker´s AEP scale validation
epilepsy

Study placed in the following topic categories:

Epilepsy
Quality of Life
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Epilepsy
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on September 02, 2009