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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01086501

Enrollment

225

Registered

2010-03-15

Start date

2010-02-28

Completion date

2012-10-31

Last updated

2013-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

open, non-interventional

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
tolerability and safety	12 months per patient

Countries

Germany

Outcome results