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

NCT ID: NCT01086501

Last Updated: 2013-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Epilepsy

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Desitin Arzneimittel GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephan Arnold, MD

Role: PRINCIPAL_INVESTIGATOR

Private Practice

Locations

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Dr. Stephan Arnold

Munich, Bavaria, Germany

Site Status

Countries

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Germany

References

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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. doi: 10.1111/j.1600-0404.2004.00291.x.

Reference Type BACKGROUND
PMID: 15147458 (View on PubMed)

Other Identifiers

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OXC-044/K

Identifier Type: -

Identifier Source: org_study_id

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