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

Partial Onset Seizures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830400
• Other study ID #: E2093-E044-404
• Status: Completed
• Phase: N/A
• First received: April 8, 2013
• Last updated: August 18, 2015
• Start date: April 2012
• Est. completion date: June 2014

Study information

• Verified date: August 2015
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Partial Onset Seizures
• Seizures

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Countries where clinical trial is conducted

Czech Republic,  Denmark,  France,  Germany,  Ireland,  Norway,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention Rate of Eslicarbazepine Acetate (ESL) After 6 months from Baseline		6 months
Secondary	Change in Overall Seizure Frequency after 3 and 6 months from Baseline	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.	Baseline, 3 months and 6 months