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

Completed

• Conditions: Partial Onset Seizures
• Interventions: Drug: Eslicarbazepine Acetate tablets

• Registration Number: NCT01830400
• Lead Sponsor: Eisai Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-04-08
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-12
• Primary Completion: 2014-03
• Study Completion: 2014-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eslicarbazepine Acetate tablets	Eslicarbazepine Acetate tablets	-

Primary Outcome Measures

Name	Time	Method
Retention Rate of Eslicarbazepine Acetate (ESL) After 6 months from Baseline	6 months

Secondary Outcome Measures

Name	Time	Method
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.