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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01830400

Enrollment

254

Registered

2013-04-12

Start date

2012-04-30

Completion date

2014-06-30

Last updated

2015-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partial Onset Seizures

Keywords

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

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.

Interventions

DRUGEslicarbazepine 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.

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Retention Rate of Eslicarbazepine Acetate (ESL) After 6 months from Baseline	6 months

Secondary

Measure	Time frame	Description
Change in Overall Seizure Frequency after 3 and 6 months from Baseline	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.

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026