ESOXC-ER Efficacy and Safety of an Extended Release (ER)... | NCT01086501

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

NCT01086501

Sponsor

Desitin Arzneimittel GmbH

Status

Completed

Last Update Posted

Mar 1, 2013Estimated

Enrollment

225Actual

Phase

Not provided

Conditions

Epilepsy

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Jul 2011Actual

Completion Date

Oct 2012Actual

First Submitted Date

Mar 12, 2010

First Submission Date that Met QC Criteria

Mar 12, 2010

First Posted Date

Mar 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2013

Last Update Posted Date

Mar 1, 2013Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

225Actual

Measure	Description	Time Frame
tolerability and safety		12 months per patient

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

newly diagnosed epileptic patients or patients who will be switched from other antiepileptic drugs to oxcarbazepine ER

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephan Arnold, MD	Private Practice	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Stephan Arnold		Munich	Bavaria	80333	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15147458	Background	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.

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases