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

A Multicenter, Non-interventional Surveillance Study to Evaluate the Adverse Effects of Antiepileptic Drug Treatment in Patients With Epilepsy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00394927

Enrollment

1000

Registered

2006-11-02

Start date

2007-04-30

Completion date

2007-08-31

Last updated

2012-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Non-Interventional, Surveillance, Adverse Effects, AntiEpileptic Drug 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

Interventions

None listed

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

4 Years to No maximum

Healthy volunteers

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

Countries

Austria, Czechia, Germany, Italy, Poland, Romania, Spain

Outcome results