Adverse Event Scale in Patients With Epilepsy (aEscape) - A European Survey for Physicians With Epilepsy Patients

This study has been completed.

Sponsors and Collaborators:	UCB International Bureau for Epilepsy
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00394927

Purpose

The purpose of the survey is to explore through a structured interview and patient examination the rate and distribution of neurological and systemic adverse effects related to antiepileptic treatment. Adverse effects and considerations to modify the therapy will be assessed in pediatric and adult patients with controlled as well as uncontrolled epilepsy with different seizure types

Condition
Epilepsy

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

MedlinePlus related topics: Epilepsy

U.S. FDA Resources

Study Type:	Observational
Official Title:	A Multicenter, Non-Interventional Surveillance Study to Evaluate the Adverse Effects of Antiepileptic Drug Treatment in Patients With Epilepsy

Further study details as provided by UCB:

Estimated Enrollment:	1000
Study Start Date:	April 2007
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	4 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female patients from the age of 4 years
Confirmed diagnosis of epilepsy requiring AED treatment
Patients already receiving daily AED treatment as a monotherapy or a polytherapy with maximum 2 AEDs within the terms of marketing authorization with the following medications: Carbamazepine, Clobazam, Clonazepam, Gabapentin, Lamotrigine, Levetiracetam, Oxcarbazepine, Phenobarbital, Phenytoin, Pregabalin, Tiagabine, Topiramate, Valproate, Zonisamide
Treatment must be stable for at least 3 months prior to assessment
Absence of other severe and/or uncontrolled symptomatic chronic illness

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394927

Show 54 Study Locations

Sponsors and Collaborators

UCB

International Bureau for Epilepsy

Investigators

Study Director:

Sonja Buyle, M.D.

UCB

More Information

Study ID Numbers:	N01228
Study First Received:	November 1, 2006
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00394927
Health Authority:	Austria: Agency for Health and Food Safety; Belgium: Ministry of Social Affairs, Public Health and the Environment; Czech Republic: State Institute for Drug Control; Germany: Federal Ministry of Food, Agriculture and Consumer Protection; Italy: Ministry of Health; Spain: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Turkey: Ministry of Health

Keywords provided by UCB:

Non-Interventional
Surveillance
Adverse Effects
AntiEpileptic Drug treatment

Study placed in the following topic categories:

Epilepsy
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009