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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:
ClinicalTrials.gov Identifier:
NCT01086501
First Posted: March 15, 2010
Last Update Posted: March 1, 2013
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.
Information provided by (Responsible Party):
Desitin Arzneimittel GmbH
  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:


Further study details as provided by Desitin Arzneimittel GmbH:

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
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
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
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 ClinicalTrials.gov identifier (NCT number): 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
First Submitted: March 12, 2010
First Posted: March 15, 2010
Last Update Posted: March 1, 2013
Last Verified: March 2010

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

Additional relevant MeSH terms:
Oxcarbazepine
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers