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

This study has been completed.
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
First received: April 8, 2013
Last updated: August 18, 2015
Last verified: August 2015
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 Eslicarbazepine Acetate (ESL) as an adjunctive therapy prior to the decision to take part in this study. Patients enrolled into the study were not sufficiently controlled with one drug licensed for the use as monotherapy in partial-onset seizures. Patients were seen at baseline and then during normal clinical visits at intervals. Patients in this study were assessed for efficacy and tolerability at baseline and then at least 3 and 6 months after the baseline.

Condition Intervention
Partial Onset Seizures
Drug: Eslicarbazepine Acetate tablets

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Open-label, Multi-centre, Multi-national Post-marketing Non-interventional Prospective Study Evaluating Retention Rate, Seizure Control and Tolerability of Eslicarbazepine Acetate (ESL) as Adjunctive Treatment to One Baseline Antiepileptic Drug in Adult Patients With Partial-Onset Seizures With or Without Secondary Generalisation

Resource links provided by NLM:

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Retention Rate of Eslicarbazepine Acetate (ESL) After 6 months from Baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Overall Seizure Frequency after 3 and 6 months from Baseline [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    Change in overall seizure frequency calculated as absolute and percent changes after 3 and 6 months from baseline compared to the seizure frequency 3 months before introduction of ESL.

Enrollment: 254
Study Start Date: April 2012
Study Completion Date: June 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Eslicarbazepine Acetate tablets Drug: Eslicarbazepine Acetate tablets
The Eslicarbazepine Acetate (ESL) Summary of Product Characteristics (SPC) recommended a starting dose of 400 mg once-daily (QD) which was increased to 800 mg QD after one or two weeks. Based on individual response, the dose was increased to 1200 mg QD. Treatment decisions were made by clinicians in agreement with the participant, and were independent of participation in the study.
Other Name: ESL


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Normal clinical practice setting/ centre.

Inclusion Criteria:

  • 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 Criteria:

  • Patients that had started ESL outside the approved SPC at enrolment
  • Simultaneous participation in an interventional clinical trial
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01830400

  Show 107 Study Locations
Sponsors and Collaborators
Eisai Inc.
Principal Investigator: Martin Holtkamp, Dr. Klinische und Experimentelle Epileptologie
  More Information

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01830400     History of Changes
Other Study ID Numbers: E2093-E044-404 
Study First Received: April 8, 2013
Last Updated: August 18, 2015
Health Authority: Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Conseil National de l'Ordre des Medecins (CNOM)
Germany: Federal Institute for Drugs and Medical Devices
Ireland: Medical Ethics Research Committee
Sweden: Institutional Review Board
United Kingdom: Research Ethics Committee

Keywords provided by Eisai Inc.:
Partial onset seizures
Retention Rate
Seizure Control
Secondary Generalisation

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Eslicarbazepine acetate
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on May 26, 2016