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NCT00394927 Clinical Trial

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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00394927
Other study ID # N01228
Secondary ID
Status Completed
Phase N/A
First received November 1, 2006
Last updated July 18, 2012
Start date April 2007
Est. completion date August 2007

Study information
Verified date July 2012
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food SafetyBelgium: Ministry of Social Affairs, Public Health and the EnvironmentCzech Republic: State Institute for Drug ControlGermany: Federal Ministry of Food, Agriculture and Consumer ProtectionItaly: Ministry of HealthSpain: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyTurkey: Ministry of Health
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 4 Years and older
Eligibility 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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
UCB Pharma International Bureau for Epilepsy

Countries where clinical trial is conducted

Austria,  Czech Republic,  Germany,  Italy,  Poland,  Romania,  Spain, 

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