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

UCB Pharma0 sites1,000 target enrollmentApril 2007

ConditionsEpilepsy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Epilepsy
Sponsor: UCB Pharma
Enrollment: 1000
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

April 2007

End Date

August 2007

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

UCB Pharma

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