NCT01086501

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 15, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 1, 2013

Status Verified

March 1, 2010

Enrollment Period

1.4 years

First QC Date

March 12, 2010

Last Update Submit

February 28, 2013

Conditions

Epilepsy

Keywords

open, non-interventional

Outcome Measures

Primary Outcomes (1)

  • tolerability and safety

    12 months per patient

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • hypersensitivity to oxcarbazepine MR or one of its excipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Stephan Arnold

Munich, Bavaria, 80333, Germany

Location

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

    PMID: 15147458BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Stephan Arnold, MD

    Private Practice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2010

First Posted

March 15, 2010

Study Start

February 1, 2010

Primary Completion

July 1, 2011

Study Completion

October 1, 2012

Last Updated

March 1, 2013

Record last verified: 2010-03

Locations

DE(1)