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NCT01086501 Clinical Trial

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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01086501
Other study ID # OXC-044/K
Secondary ID
Status Completed
Phase N/A
First received March 12, 2010
Last updated February 28, 2013
Start date February 2010
Est. completion date October 2012

Study information
Verified date March 2010
Source Desitin Arzneimittel GmbH
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 225
Est. completion date October 2012
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 6 Years and older
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Dr. Stephan Arnold Munich Bavaria

Sponsors (1)
Lead Sponsor Collaborator
Desitin Arzneimittel GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Miller AD, Krauss GL, Hamzeh FM. Improved CNS tolerability following conversion from immediate- to extended-release carbamazepine. Acta Neurol Scand. 2004 Jun;109(6):374-7. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary tolerability and safety 12 months per patient Yes
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