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.
- Conditions
- G40.2Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures
- Registration Number
- DRKS00025524
- Lead Sponsor
- Parexel International (IRL) Limited (Clinical Research Organisation)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 600
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).
Patients who have not initiated BRV within 90 days of initial data consent
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method