A 12-month, non-interventional, 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.

A 12-month, non-interventional, 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/EP0103

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00025524

Enrollment

600

Registered

2021-10-13

Start date

2021-11-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G40.2

Interventions

Group 1: Brivaracetam will be prescribed according to standard clinical practice. Each patient will be followed for up to 12 months with 5 study visits. The study consists of only 1 cohort and up to 2

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. The decision by the treating physician to prescribe BRV must be made independently from participation in the non-interventional study, and is in line with the drug’s license and the (local) Summary of Product Characteristics (SmPC). 2. A Patient Data Consent Form must be signed and dated by the patient. 3. The patient must be considered by the treating physician to be reliable and capable of adhering to the protocol. 4. The patient must not have been previously treated with BRV. 5. The patient must have a history of epilepsy for at least 6 months. 6. The patient must have a history of partial-onset (focal) seizures. The patient must have had at least 1 POS (focal aware [simple partial], focal with impaired awareness [complex partial], or focal to bilateral tonic clonic seizure [secondarily generalized tonic clonic]) within 3 months prior to Baseline (Visit 1). 7. The patient must be receiving =1 AED at the start of BRV treatment. The patient must have failed no more than 3 lifetime AEDs used for the treatment of seizures, including all prior and concomitant AEDs at Baseline (Visit 1) before BRV initiation (excluding benzodiazepines used short term as rescue medications).

Exclusion criteria

Exclusion criteria: Patients who have not initiated BRV within 90 days of initial data consent

Design outcomes

Primary

Measure	Time frame
To evaluate the effectiveness of BRV in earlier treatment line combinations in patients with POS with or without secondary generalization for up to 12 months of treatment.	—

Secondary

Measure	Time frame
To assess the effectiveness of BRV treatment in earlier treatment line combinations	—

Countries

Canada, France, Germany, Italy, Spain

Contacts

Public ContactAndreas Schulze-Bonhage

Universitätsklinikum Freiburg, Epilepsiezentrum

epilepsiezentrum@uniklinik-freiburg.de0761 27053660

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026