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

NCT ID: NCT01830400

Last Updated: 2015-08-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 254 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-06-30

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.

Conditions

Partial Onset Seizures

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Eslicarbazepine Acetate tablets

Eslicarbazepine Acetate tablets

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

ESL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Holtkamp, Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinische und Experimentelle Epileptologie

Locations

Hradec Králové, , Czechia

Kroměříž, , Czechia

Prague, , Czechia

Aalborg, , Denmark

Arhus C, , Denmark

Copenhagen, , Denmark

Dianalund, , Denmark

Esbjerg, , Denmark

Glostrup Municipality, , Denmark

Holstebro, , Denmark

Roskilde, , Denmark

Sønderborg, , Denmark

Vejle, , Denmark

Altkirch, , France

Armentières, , France

Bergerac, , France

Biarritz, , France

Chaumont, , France

Cholet, , France

Gap, , France

Nice, , France

Nîmes, , France

Paris, , France

Perpignan, , France

Rueil-Malmaison, , France

Sarreguemines, , France

Toulon, , France

Altenholz, , Germany

Asperg, , Germany

Augsburg, , Germany

Bad Berka, , Germany

Bad Langensalza, , Germany

Berlin, , Germany

Beuel, , Germany

Bielefeld, , Germany

Bochum, , Germany

Bockhorn, , Germany

Buxtehude, , Germany

Cologne, , Germany

Dortmund, , Germany

Erbach im Odenwald, , Germany

Erlangen, , Germany

Etville, , Germany

Gelsenkirchen, , Germany

Gera, , Germany

Greiz, , Germany

Grevenbroich, , Germany

Guelders, , Germany

Hamburg, , Germany

Hamm, , Germany

Heilbad Heiligenstadt, , Germany

Herdecke, , Germany

Hildesheim, , Germany

Hof, , Germany

Ilmenau, , Germany

Itzehoe, , Germany

Kamp-Lintfort, , Germany

Kirchen (Sieg), , Germany

Königsbrück, , Germany

Leipzig, , Germany

Leverkusen, , Germany

Lohr a. Main, , Germany

Ludwigsburg, , Germany

Mannheim, , Germany

Mittweida, , Germany

München, , Germany

Oranienburg, , Germany

Osnabrück, , Germany

Quakenbrück, , Germany

Rathenow, , Germany

Salzgitter, , Germany

Schirgiswalde-Kirschau, , Germany

Schorndorf, , Germany

Schwäbisch Gmünd, , Germany

Senftenberg, , Germany

Solingen, , Germany

Stuttgart, , Germany

Troisdorf (Sieglar), , Germany

Waiblingen, , Germany

Wesel, , Germany

Westerstede, , Germany

Wilhelmshaven, , Germany

Wolfsburg, , Germany

Würzburg, , Germany

Dooradoyle/ Co. Limerick, , Ireland

Dublin, , Ireland

Bergen, , Norway

Molde, , Norway

Oslo, , Norway

Skien, , Norway

Angered, , Sweden

Helsingborg, , Sweden

Kungsbacka, , Sweden

Linköping, , Sweden

Stockholm / Saint Goran, , Sweden

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

Countries

Czechia; Denmark; France; Germany; Ireland; Norway; Sweden; United Kingdom

Other Identifiers

E2093-E044-404

Identifier Type: -

Identifier Source: org_study_id