A 12-MONTH NONINTERVENTIONAL OBSERVATIONAL MULTINATIONAL STUDY TO EVALUATE EFFECTIVENESS, TOLERABILITY, AND QUALITY OF LIFE OF BRIVARACETAM ADJUNCTIVE THERAPY IN EARLIER TREATMENT LINES IN ADULT PATIENTS WITH HISTORY OF PARTIAL-ONSET SEIZURES IN DAILY CLINICAL PRACTICE (BRITOBA)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Tolerability, health-related quality of life and treatment satisfaction

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  The primary objective of the study is to evaluate the effectiveness of BRV in earlier treatment line combinations in patients with POS with or without secondary generalization for approximately 12 months of treatment.
• Outcomes:
  Seizure freedom for at least 6 consecutive months over a 12-month observation period. -BRV retention at 3, 6, 9 & 12 months -Seizure freedom at 3, 6, 9, & 12 months -POS frequency at Baseline, 3, 6, 9, & 12 months -Change (absolute & percent) in POS frequency from Baseline to 3, 6, 9, & 12 months -Response based on percent change in POS frequency at 3, 6, 9, & 12 months -Discontinuation of BRV due to lack of effectiveness -Time to discontinuation of BRV treatment
• Data analysis plan:
  Variables will be summarized using descriptive statistics. For continuous variables, summary statistics (number of available observations, mean, standard deviation, minimum, median, maximum, and 25% and 75% quartiles where relevant) will be tabulated. Categorical variables will be summarized by the frequency and percentage of patients in each category. The primary endpoint is the proportion of patients achieving six consecutive months of seizure freedom over the duration of the 12-month study and will be presented with a 2-sided 95% confidence interval (CI). Secondary endpoints include percentage change in POS frequency (change from baseline) and proportion of patients experiencing retention of BRV. Patient reported outcomes (PROs) will be presented using frequency distributions or change from baseline of total scores or domain scores (as applicable). Summary of safety endpoints include focus on incidence rates of AEs and BRV dosing.