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 identification

• EU PAS number:
  EUPAS41206
• Study ID:
  50035
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  France

  Germany

  Italy

  Spain
• Study description:
  EP0103 is a post-marketing, multinational, observational, prospective non-interventional study (NIS) to evaluate effectiveness, tolerability, and quality of life of adjunctive Brivaracetam (BRV) therapy in earlier treatment line combinations in adult patients with history of partial-onset seizures (POS). In addition, this study may allow the exploration of predictions of response in patients in earlier treatment line combinations. Brivaracetam will be prescribed according to standard clinical practice.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual:09/07/2020

Study start date

Actual:11/12/2020

Data analysis start date

Planned:28/02/2024

Actual:20/02/2024

Date of final study report

Planned:30/06/2024

Actual:10/10/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

UCB Biopharma SRL

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable