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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01830400
Recruitment Status : Completed
First Posted : April 12, 2013
Last Update Posted : August 19, 2015
Information provided by (Responsible Party):
Eisai Inc.

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 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 or disease Intervention/treatment
Partial Onset Seizures Drug: Eslicarbazepine Acetate tablets

Study Type : Observational
Actual Enrollment : 254 participants
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
Study Start Date : April 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Retention Rate of Eslicarbazepine Acetate (ESL) After 6 months from Baseline [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in Overall Seizure Frequency after 3 and 6 months from Baseline [ Time Frame: Baseline, 3 months and 6 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01830400

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

Responsible Party: Eisai Inc. Identifier: NCT01830400     History of Changes
Other Study ID Numbers: E2093-E044-404
First Posted: April 12, 2013    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015

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
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action