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

This study has been completed.
Sponsor:
Collaborator:
International Bureau for Epilepsy
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00394927
First received: November 1, 2006
Last updated: July 18, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition
Epilepsy

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: A Multicenter, Non-interventional Surveillance Study to Evaluate the Adverse Effects of Antiepileptic Drug Treatment in Patients With Epilepsy

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Estimated Enrollment: 1000
Study Start Date: April 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394927

  Show 54 Study Locations
Sponsors and Collaborators
UCB, Inc.
International Bureau for Epilepsy
Investigators
Study Director: Sonja Buyle, M.D. UCB, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00394927     History of Changes
Other Study ID Numbers: N01228
Study First Received: November 1, 2006
Last Updated: July 18, 2012
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Ministry of Social Affairs, Public Health and the Environment
Czech Republic: State Institute for Drug Control
Germany: Federal Ministry of Food, Agriculture and Consumer Protection
Italy: Ministry of Health
Spain: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Turkey: Ministry of Health

Keywords provided by UCB, Inc.:
Non-Interventional
Surveillance
Adverse Effects
AntiEpileptic Drug treatment

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013