Clinical trial NCT00394927: Adverse Event Scale in Patients With Epilepsy (aEscape) - A European Survey for Physicians With Epilepsy Patients
Official title: A Multicenter, Non-interventional Surveillance Study to Evaluate the Adverse Effects of Antiepileptic Drug Treatment in Patients With Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Non-Interventional
Surveillance
Adverse Effects
AntiEpileptic Drug treatment
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: International Bureau for Epilepsy
First posted: 2006-11-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed diagnosis of epilepsy requiring anti-epileptic treatment and which are already receiving daily anti-epileptic treatment

Brief summary: 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


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wien
country: Austria
city: Blansko
country: Czech Republic
city: Ceske Budejovice
country: Czech Republic
city: Hradec Kralove
country: Czech Republic
city: Karlovy Vary
country: Czech Republic
city: Koprivnice
country: Czech Republic
city: Kromeriz
country: Czech Republic
city: Liberec
country: Czech Republic
city: Litomysl
country: Czech Republic
city: Nachod
country: Czech Republic
city: Nove Mesto Na Morave
country: Czech Republic
city: Praha 10
country: Czech Republic
city: Teplice
country: Czech Republic
city: Trebic
country: Czech Republic
city: Usti Nad Labem
country: Czech Republic
city: Zlin
country: Czech Republic
city: Aschaffenburg
country: Germany
city: Berlin
country: Germany
city: Bielefeld
country: Germany
city: Bochum
country: Germany
city: Dusseldorf
country: Germany
city: Ellwangen
country: Germany
city: Göttingen
country: Germany
city: Hirschaid
country: Germany
city: Jena
country: Germany
city: Krefeld
country: Germany
city: Köln
country: Germany
city: Königsbrück
country: Germany
city: Leipzig
country: Germany
city: Munchen
country: Germany
city: München
country: Germany
city: Neuberg
country: Germany
city: Oelde
country: Germany
city: Albano Laziale (Roma)
country: Italy
city: Napoli
country: Italy
city: Bialystok
country: Poland
city: Elblag
country: Poland
city: Gdansk
country: Poland
city: Katowice
country: Poland
city: Kielce
country: Poland
city: Kraków
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Botosani
country: Romania
city: Brasov
country: Romania
city: Bucharest
country: Romania
city: Craiova
country: Romania
city: Galati
country: Romania
city: Iasi
country: Romania
city: Lasi
country: Romania
city: Timisoara
country: Romania
city: Sant Boi De Llobregat
country: Spain
Study officials:
affiliation: UCB Pharma
name: Sonja Buyle, M.D.
role: STUDY_DIRECTOR
References: