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 (EPOS)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Efficacy and tolerability Study
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Other- Phase IV open label study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ESLICARBAZEPINE ACETATE
• Medical condition to be studied:
  Partial seizures

Population studied

• Short description of the study population:
  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.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients experiencing partial-onset seizures
• Estimated number of subjects:
  219

Study design details

• Main study objective:
  Patients in this study will be assessed for efficacy and tolerability at baseline and then at least 3 and 6 months after the baseline.
• Outcomes:
  Retention Rate After 6 Months From Baseline Time Frame: Baseline (Visit 1) to Month 6 (Visit 3), Retention Rate, Total Seizure Frequency, Percentage of Seizure-Free Participants, Percentage of Responders, Percent Discontinuation of Study Treatment Due to a Lack of Efficacy, Time to Discontinuation of ESL Treatment, Quality of Life using Epilepsy Inventory (QOLIE-10), Clinical Global Impression (CGI) Severity of Illness, CGI Global Improvement, and CGI Efficacy Index.
• Data analysis plan:
  Quantitative variables were analyzed by means of basic statistical parameters, qualitative and ordinal scaled variables were presented as absolute and relative frequency distributions. Relative frequencies were based on the number of available data, i.e. excluding missing data. No imputation methods of missing values were applied to the data. Additionally, two sided 95%-confidence intervals (CI) were calculated for the retention rates over 3 and over 6 months, respectively. For subgroup analyses, patients were classified according to gender, age (≤ 60 years, > 60 years), number of discontinued AED regimens within the last 5 years prior to baseline and most frequently used baseline AEDs (carbamazepine, levetiracetam, lamotrigine and valproate), and occurrence of adaptations of adjunct AED regimen throughout the study. All analyses were performed with the SAS® package, version 9.2 (SAS Institute, Cray, NC, USA).