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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01086501
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : March 1, 2013
Information provided by (Responsible Party):
Desitin Arzneimittel GmbH

Brief Summary:
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 or disease

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Study Type : Observational
Actual Enrollment : 225 participants
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
Study Start Date : February 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Primary Outcome Measures :
  1. tolerability and safety [ Time Frame: 12 months per patient ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01086501

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Dr. Stephan Arnold
Munich, Bavaria, Germany, 80333
Sponsors and Collaborators
Desitin Arzneimittel GmbH
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Principal Investigator: Stephan Arnold, MD Private Practice
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Responsible Party: Desitin Arzneimittel GmbH Identifier: NCT01086501    
Other Study ID Numbers: OXC-044/K
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: March 1, 2013
Last Verified: March 2010
Keywords provided by Desitin Arzneimittel GmbH:
open, non-interventional
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases