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

NCT ID: NCT00394927

Last Updated: 2012-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Epilepsy

Keywords

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Non-Interventional Surveillance Adverse Effects AntiEpileptic Drug treatment

Study Design

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Observational Model Type

COHORT

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Bureau for Epilepsy

OTHER

Sponsor Role collaborator

UCB Pharma

INDUSTRY

Sponsor Role lead

Principal Investigators

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Sonja Buyle, M.D.

Role: STUDY_DIRECTOR

UCB Pharma

Locations

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Vienna, , Austria

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Blansko, , Czechia

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České Budějovice, , Czechia

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Hradec Králové, , Czechia

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Karlovy Vary, , Czechia

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Kopřivnice, , Czechia

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Kroměříž, , Czechia

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Liberec, , Czechia

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Litomyšl, , Czechia

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Náchod, , Czechia

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Nové Město na Moravě, , Czechia

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Prague, , Czechia

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Teplice, , Czechia

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Třebíč, , Czechia

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Ústí nad Labem, , Czechia

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Zlín, , Czechia

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Aschaffenburg, , Germany

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Berlin, , Germany

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Bielefeld, , Germany

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Bochum, , Germany

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Cologne, , Germany

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Düsseldorf, , Germany

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Ellwangen, , Germany

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Göttingen, , Germany

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Hirschaid, , Germany

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Jena, , Germany

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Königsbrück, , Germany

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Krefeld, , Germany

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Leipzig, , Germany

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München, , Germany

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Neuberg, , Germany

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Oelde, , Germany

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Albano Laziale (Roma), , Italy

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Napoli, , Italy

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Bialystok, , Poland

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Elblag, , Poland

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Gdansk, , Poland

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Katowice, , Poland

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Kielce, , Poland

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Krakow, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Botoșani, , Romania

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Brasov, , Romania

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Bucharest, , Romania

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Craiova, , Romania

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Galati, , Romania

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Iași, , Romania

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Lasi, , Romania

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Timișoara, , Romania

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Sant Boi de Llobregat, , Spain

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Countries

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Austria Czechia Germany Italy Poland Romania Spain

Other Identifiers

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N01228

Identifier Type: -

Identifier Source: org_study_id