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ESOXC-ER Efficacy and Safety of an Extended Release (ER) Formulation of Oxcarbazepine (Apydan Extent) in Epileptic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier:
NCT01086501
First received: March 12, 2010
Last updated: February 28, 2013
Last verified: March 2010
History of Changes
  Purpose

The aim of the observational study is to investigate the safety of oxcarbazepine extended release (ER) during long-term therapy in epileptic patients. In addition, quality of life parameters should be documented if assessed.


Condition
Epilepsy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Efficacy and Safety of an ER-formulation of Oxcarbazepine (Apydan Extent) in Epileptic Patients Under Consideration of Quality of Life Parameters

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Further study details as provided by Desitin Arzneimittel GmbH:

Primary Outcome Measures:
  • tolerability and safety [ Time Frame: 12 months per patient ] [ Designated as safety issue: Yes ]

Enrollment: 225
Study Start Date: February 2010
Study Completion Date: October 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

newly diagnosed epileptic patients or patients who will be switched from other antiepileptic drugs to oxcarbazepine ER

Criteria

Inclusion Criteria:

  • patients with focal epileptic seizures with or without secondary generalised tonic-clonic seizures
  • mono- or combination therapy
  • male and female from the age of 6

Exclusion Criteria:

  • hypersensitivity to oxcarbazepine MR or one of its excipients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01086501

Locations
Germany
Dr. Stephan Arnold
Munich, Bavaria, Germany, 80333
Sponsors and Collaborators
Desitin Arzneimittel GmbH
Investigators
Principal Investigator: Stephan Arnold, MD Private Practice
  More Information

Publications:

Responsible Party: Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier: NCT01086501     History of Changes
Other Study ID Numbers: OXC-044/K
Study First Received: March 12, 2010
Last Updated: February 28, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Desitin Arzneimittel GmbH:
open, non-interventional

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

ClinicalTrials.gov processed this record on May 16, 2013