Status:

COMPLETED

A Post-marketing Study Evaluating Eslicarbazepine Acetate (ESL) as Adjunctive Treatment in Partial-Onset Seizures (Study E2093-E044-404) (EPOS)

Lead Sponsor:

Eisai Inc.

Conditions:

Partial Onset Seizures

Eligibility:

All Genders

18+ years

Brief Summary

This was a Non-interventional Prospective Study. Centres enrolled adult patients with partial-onset seizures with or without secondary generalisation for whom the clinician had decided to initiate Esl...

Eligibility Criteria

Inclusion

  • The decision to prescribe ESL was made by the physician before and independently of his/her decision to include the patient in the study
  • Patients treated with one drug licensed for monotherapy in partial onset seizures
  • Based on the physician's clinical judgment, the patient seizure activity was not controlled sufficiently with a current monotherapy and it was in the patient's best interest to be prescribed adjunctive ESL
  • Patient was prescribed ESL no longer than 2 weeks before the baseline
  • Treatment with ESL was to be commenced in line with the drug's license and Eslicarbazepine Acetate (ESL) Summary of Product Characteristics (SPC)
  • Aged 18 years or older
  • Signed written informed consent

Exclusion

  • Patients that had started ESL outside the approved SPC at enrolment
  • Simultaneous participation in an interventional clinical trial

Key Trial Info

Start Date :

April 1 2012

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 1 2014

Estimated Enrollment :

254 Patients enrolled

Trial Details

Trial ID

NCT01830400

Start Date

April 1 2012

End Date

June 1 2014

Last Update

August 19 2015

Active Locations (106)

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Page 1 of 27 (106 locations)

1

Hradec Králové, Czechia

2

Kroměříž, Czechia

3

Prague, Czechia

4

Aalborg, Denmark