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

NCT01830400 | Completed

• 1 other identifier: E2093-E044-404
• Study Type: observational
• Target: 254
• Locations: 8 countries
• Sites: 106

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

Keywords

ESL; Partial onset seizures; Retention Rate; Seizure Control; Antiepileptic; Secondary Generalisation

Outcome Measures

Primary Outcomes (1)

• Retention Rate of Eslicarbazepine Acetate (ESL) After 6 months from Baseline

  6 months

Secondary Outcomes (1)

• Change in Overall Seizure Frequency after 3 and 6 months from Baseline

  Baseline, 3 months and 6 months

Study Arms (1)

Eslicarbazepine Acetate tablets

Drug: Eslicarbazepine Acetate tablets

Interventions

Eslicarbazepine Acetate tablets 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.

Also known as: ESL

Eslicarbazepine Acetate tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normal clinical practice setting/ centre.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (106)

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Hradec Králové, Czechia

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Kroměříž, Czechia

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Prague, Czechia

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Aalborg, Denmark

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Arhus C, Denmark

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Copenhagen, Denmark

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Dianalund, Denmark

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Esbjerg, Denmark

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Glostrup Municipality, Denmark

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Holstebro, Denmark

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Roskilde, Denmark

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Sønderborg, Denmark

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Vejle, Denmark

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Altkirch, France

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Armentières, France

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Bergerac, France

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Biarritz, France

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Chaumont, France

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Cholet, France

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Gap, France

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Nice, France

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Nîmes, France

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Paris, France

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Perpignan, France

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Rueil-Malmaison, France

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Sarreguemines, France

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Toulon, France

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Altenholz, Germany

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Asperg, Germany

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Augsburg, Germany

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Bad Berka, Germany

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Bad Langensalza, Germany

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Berlin, Germany

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Beuel, Germany

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Bielefeld, Germany

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Bochum, Germany

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Bockhorn, Germany

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Buxtehude, Germany

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Cologne, Germany

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Dortmund, Germany

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Erbach im Odenwald, Germany

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Erlangen, Germany

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Etville, Germany

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Gelsenkirchen, Germany

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Gera, Germany

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Greiz, Germany

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Grevenbroich, Germany

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Guelders, Germany

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Hamburg, Germany

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Hamm, Germany

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Heilbad Heiligenstadt, Germany

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Herdecke, Germany

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Hildesheim, Germany

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Hof, Germany

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Ilmenau, Germany

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Itzehoe, Germany

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Kamp-Lintfort, Germany

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Kirchen (Sieg), Germany

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Königsbrück, Germany

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Leipzig, Germany

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Leverkusen, Germany

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Lohr a. Main, Germany

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Ludwigsburg, Germany

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Mannheim, Germany

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Mittweida, Germany

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München, Germany

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Oranienburg, Germany

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Osnabrück, Germany

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Quakenbrück, Germany

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Rathenow, Germany

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Salzgitter, Germany

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Schirgiswalde-Kirschau, Germany

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Schorndorf, Germany

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Schwäbisch Gmünd, Germany

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Senftenberg, Germany

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Solingen, Germany

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Stuttgart, Germany

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Troisdorf (Sieglar), Germany

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Waiblingen, Germany

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Wesel, Germany

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Westerstede, Germany

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Wilhelmshaven, Germany

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Wolfsburg, Germany

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Würzburg, Germany

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Dooradoyle/ Co. Limerick, Ireland

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Dublin, Ireland

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Bergen, Norway

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Molde, Norway

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Oslo, Norway

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Skien, Norway

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Angered, Sweden

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Helsingborg, Sweden

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Kungsbacka, Sweden

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Linköping, Sweden

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Stockholm / Saint Goran, Sweden

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Birmingham, United Kingdom

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Dundee, United Kingdom

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London, United Kingdom

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Middlesbrough, United Kingdom

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Newport, United Kingdom

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Romford, United Kingdom

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Salford, United Kingdom

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Stoke-on-Trent, United Kingdom

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Telford, United Kingdom

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Torquay, Devon, United Kingdom

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Truro, United Kingdom

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MeSH Terms

Interventions

eslicarbazepine acetate

Study Officials

• Martin Holtkamp, Dr.

  Klinische und Experimentelle Epileptologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 12, 2013
• Study Start: April 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 19, 2015

Record last verified: 2015-08

Locations

NO (4); FR (14); IE (2); SE (5); DE (57); DK (10); CZ (3); GB (11)