Clinical trial NCT01830400: A Post-marketing Study Evaluating Eslicarbazepine Acetate (ESL) as Adjunctive Treatment in Partial-Onset Seizures (Study E2093-E044-404) (EPOS)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Partial Onset Seizures
Keywords: ESL
Partial onset seizures
Retention Rate
Seizure Control
Antiepileptic
Secondary Generalisation
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-12
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal clinical practice setting/ centre.

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.


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

Primary outcomes:
measure: Retention Rate of Eslicarbazepine Acetate (ESL) After 6 months from Baseline
timeFrame: 6 months
Secondary outcomes:
measure: Change in Overall Seizure Frequency after 3 and 6 months from Baseline
timeFrame: Baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Hradec Kralove 3
country: Czech Republic
city: Kromeriz
country: Czech Republic
city: Praha 5
country: Czech Republic
city: Aalborg
country: Denmark
city: Arhus C
country: Denmark
city: Copenhagen
country: Denmark
city: Dianalund
country: Denmark
city: Esbjerg
country: Denmark
city: Glostrup
country: Denmark
city: Holstebro
country: Denmark
city: Roskilde
country: Denmark
city: Sonderborg
country: Denmark
city: Vejle
country: Denmark
city: Altkirch
country: France
city: Armentieres
country: France
city: Bergerac
country: France
city: Biarritz
country: France
city: Chaumont
country: France
city: Cholet
country: France
city: Gap
country: France
city: Nice
country: France
city: Nimes
country: France
city: Paris
country: France
city: Perpignan
country: France
city: Rueil Malmaison
country: France
city: Sarreguemines
country: France
city: Toulon
country: France
city: Altenholz
country: Germany
city: Asperg
country: Germany
city: Augsburg
country: Germany
city: Bad Berka
country: Germany
city: Bad Langensalza
country: Germany
city: Berlin
country: Germany
city: Bielefeld
country: Germany
city: Bochum
country: Germany
city: Bockhorn
country: Germany
city: Bonn-Beuel
country: Germany
city: Buxtehude
country: Germany
city: Dortmund
country: Germany
city: Erbach
country: Germany
city: Erlangen
country: Germany
city: Etville
country: Germany
city: Geldern
country: Germany
city: Gelsenkirchen
country: Germany
city: Gera
country: Germany
city: Greiz
country: Germany
city: Grevenbroich
country: Germany
city: Hamburg
country: Germany
city: Hamm
country: Germany
city: Heilbad Heiligenstadt
country: Germany
city: Herdecke
country: Germany
city: Hildesheim
country: Germany
city: Hof
country: Germany
city: Ilmenau
country: Germany
city: Itzehoe
country: Germany
city: Kamp-Lintfort
country: Germany
city: Kirchen (Sieg)
country: Germany
city: Koln
country: Germany
city: Konigsbruck
country: Germany
city: Leipzig
country: Germany
city: Leverkusen
country: Germany
city: Lohr am Main
country: Germany
city: Ludwigsburg
country: Germany
city: Mannheim
country: Germany
city: Mittweida
country: Germany
city: Munchen
country: Germany
city: Oranienburg
country: Germany
city: Osnabruck
country: Germany
city: Quakenbruck
country: Germany
city: Rathenow
country: Germany
city: Salzgitter
country: Germany
city: Schirgiswalde-Kirschau
country: Germany
city: Schorndorf
country: Germany
city: Schwabisch Gmund
country: Germany
city: Senftenberg
country: Germany
city: Solingen
country: Germany
city: Stuttgart
country: Germany
city: Troisdorf (Sieglar)
country: Germany
city: Waiblingen
country: Germany
city: Wesel
country: Germany
city: Westerstede
country: Germany
city: Wilhelmshaven
country: Germany
city: Wolfsburg
country: Germany
city: Wurzburg
country: Germany
city: Dooradoyle/ Co. Limerick
country: Ireland
city: Dublin 24
country: Ireland
city: Dublin 8
country: Ireland
city: Bergen
country: Norway
city: Molde
country: Norway
city: Oslo
country: Norway
city: Skien
country: Norway
city: Angered
country: Sweden
city: Helsingborg
country: Sweden
city: Kungsbacka
country: Sweden
city: Linkoping
country: Sweden
city: Stockholm / St. Goran
country: Sweden
city: Birmingham
country: United Kingdom
city: Dundee
country: United Kingdom
city: London
country: United Kingdom
city: Middlesbrough
country: United Kingdom
city: Newport
country: United Kingdom
city: Romford
country: United Kingdom
city: Salford
country: United Kingdom
city: Stoke-on-Trent
country: United Kingdom
city: Telford
country: United Kingdom
city: Torquay, Devon
country: United Kingdom
city: Truro
country: United Kingdom
Study officials:
affiliation: Klinische und Experimentelle Epileptologie
name: Martin Holtkamp, Dr.
role: PRINCIPAL_INVESTIGATOR
References: