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

August 18, 2015 updated by: Eisai Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

254

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Hradec Kralove 3, Czech Republic
      • Kromeriz, Czech Republic
      • Praha 5, Czech Republic
  • Denmark
      • Aalborg, Denmark
      • Arhus C, Denmark
      • Copenhagen, Denmark
      • Dianalund, Denmark
      • Esbjerg, Denmark
      • Glostrup, Denmark
      • Holstebro, Denmark
      • Roskilde, Denmark
      • Sonderborg, Denmark
      • Vejle, Denmark
  • France
      • Altkirch, France
      • Armentieres, France
      • Bergerac, France
      • Biarritz, France
      • Chaumont, France
      • Cholet, France
      • Gap, France
      • Nice, France
      • Nimes, France
      • Paris, France
      • Perpignan, France
      • Rueil Malmaison, France
      • Sarreguemines, France
      • Toulon, France
  • Germany
      • Altenholz, Germany
      • Asperg, Germany
      • Augsburg, Germany
      • Bad Berka, Germany
      • Bad Langensalza, Germany
      • Berlin, Germany
      • Bielefeld, Germany
      • Bochum, Germany
      • Bockhorn, Germany
      • Bonn-Beuel, Germany
      • Buxtehude, Germany
      • Dortmund, Germany
      • Erbach, Germany
      • Erlangen, Germany
      • Etville, Germany
      • Geldern, Germany
      • Gelsenkirchen, Germany
      • Gera, Germany
      • Greiz, Germany
      • Grevenbroich, Germany
      • Hamburg, Germany
      • Hamm, Germany
      • Heilbad Heiligenstadt, Germany
      • Herdecke, Germany
      • Hildesheim, Germany
      • Hof, Germany
      • Ilmenau, Germany
      • Itzehoe, Germany
      • Kamp-Lintfort, Germany
      • Kirchen (Sieg), Germany
      • Koln, Germany
      • Konigsbruck, Germany
      • Leipzig, Germany
      • Leverkusen, Germany
      • Lohr am Main, Germany
      • Ludwigsburg, Germany
      • Mannheim, Germany
      • Mittweida, Germany
      • Munchen, Germany
      • Oranienburg, Germany
      • Osnabruck, Germany
      • Quakenbruck, Germany
      • Rathenow, Germany
      • Salzgitter, Germany
      • Schirgiswalde-Kirschau, Germany
      • Schorndorf, Germany
      • Schwabisch Gmund, Germany
      • Senftenberg, Germany
      • Solingen, Germany
      • Stuttgart, Germany
      • Troisdorf (Sieglar), Germany
      • Waiblingen, Germany
      • Wesel, Germany
      • Westerstede, Germany
      • Wilhelmshaven, Germany
      • Wolfsburg, Germany
      • Wurzburg, Germany
  • Ireland
      • Dooradoyle/ Co. Limerick, Ireland
      • Dublin 24, Ireland
      • Dublin 8, Ireland
  • Norway
      • Bergen, Norway
      • Molde, Norway
      • Oslo, Norway
      • Skien, Norway
  • Sweden
      • Angered, Sweden
      • Helsingborg, Sweden
      • Kungsbacka, Sweden
      • Linkoping, Sweden
      • Stockholm / St. Goran, Sweden
  • United Kingdom
      • Birmingham, United Kingdom
      • Dundee, United Kingdom
      • London, United Kingdom
      • Middlesbrough, United Kingdom
      • Newport, United Kingdom
      • Romford, United Kingdom
      • Salford, United Kingdom
      • Stoke-on-Trent, United Kingdom
      • Telford, United Kingdom
      • Torquay, Devon, United Kingdom
      • Truro, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Normal clinical practice setting/ centre.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • ESL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retention Rate of Eslicarbazepine Acetate (ESL) After 6 months from Baseline
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Investigators

  • Principal Investigator: Martin Holtkamp, Dr., Klinische und Experimentelle Epileptologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

April 8, 2013

First Submitted That Met QC Criteria

April 11, 2013

First Posted (ESTIMATE)

April 12, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2093-E044-404

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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