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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Stephan Arnold

Munich, Bavaria, 80333, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

tolerability and safety

Time frame: 12 months per patient

Sponsors and collaborators

Lead sponsor

Desitin Arzneimittel GmbH

Industry

Registry information

Official study title

Efficacy and Safety of an ER-formulation of Oxcarbazepine (Apydan Extent) in Epileptic Patients Under Consideration of Quality of Life Parameters

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2012
First posted: Mar 15, 2010
Registry last updated: Mar 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed