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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
  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 ] [ 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
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, see Learn About Clinical Studies.

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:
Oxcarbazepine
Anticonvulsants
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 25, 2014