A Post-marketing Study Evaluating Eslicarbazepine Acetate (ESL) as Adjunctive Treatment in Partial-Onset Seizures (Study E2093-E044-404) (EPOS)
This is a Non-interventional Prospective Study. Centres will enroll adult patients with partial-onset seizures with or without secondary generalisation for whom the clinician has decided to initiate Eslicarbazepine Acetate (ESL) as an adjunctive therapy prior to the decision to take part in this study. Patients to be enrolled into the study are not sufficiently controlled with one drug licensed for the use as monotherapy in partial-onset seizures. Patients will be seen at baseline and then during normal clinical visits at intervals. Patients in this study will be assessed for efficacy and tolerability at baseline and then at least 3 and 6 months after the baseline.
|Study Design:||Time Perspective: Prospective|
|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|
- Retention Rate of Eslicarbazepine Acetate (ESL) After 6 months from Baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in Overall Seizure Frequency after 3 and 6 months from Baseline [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2013|
|Study Completion Date:||June 2014|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
|Eslicarbazepine Acetate tablets||
Drug: Eslicarbazepine Acetate tablets
The Eslicarbazepine Acetate (ESL) Summary of Product Characteristics (SPC) recommends a starting dose of 400 mg once-daily (QD) which should be increased to 800 mg QD after one or two weeks. Based on individual response, the dose may be increased to 1200 mg QD. Treatment decisions will be made by clinicians in agreement with the participant, and will be independent of participation in the study.
Other Name: ESL
Please refer to this study by its ClinicalTrials.gov identifier: NCT01830400
Show 107 Study Locations
|Principal Investigator:||Martin Holtkamp, Dr.||Klinische und Experimentelle Epileptologie|