Treatments for epilepsy are under constant evolution, as doctors and researchers investigate new tools and therapies to improve epilepsy care. Clinical trials create a controlled and supervised environment to conduct experiments for testing new ideas or hypotheses. Some clinical trials are designed to understand the mechanism of the disease; others investigate new treatments (such as a new medication or surgical procedure) to determine their effects on the disease and patient symptoms.
Multicenter 1-Year Observational Study of Patients who are Initiating Brivaracetam
EP0088 is a post marketing, multi-center, prospective, non-interventional study (NIS) conducted at up to approximately 45 sites in the US, with an estimated 18-month Enrollment Period and a 12-month Observation Period per patient from the initiation of BRV. Briviact® (brivaracetam [BRV]) has been approved by the US Food and Drug Administration (FDA) as adjunctive therapy in the treatment of partial-onset seizures (POS) with or without secondary generalization in patients 16 years of age and older with epilepsy. Brivaracetam will be prescribed according to normal clinical practice. The sponsors plan is to enroll up to 350 patients in the study.
- The overall objective of this study is to inform BRV clinical decisions through real-life experience to achieve better patient outcomes.
- All patients (and/or their parents or legal representatives) have to accept in writing that his/her medical data will be used for the evaluation of the study results by signing a study-specific Patient Data Consent form according to local requirements.
- The clinical care of patients with epilepsy will be performed by the treating physician following standard clinical practice. It is anticipated that each patient will be evaluated for purposes of this study on up to 6 routine clinical visits (some by telephone or video chat) during their participation.
- Patients will be selected from recruiting sites’ clinics based on physician and patient decision to initiate therapy with BRV. Investigators and study coordinators will review clinic visits and treatment plans for newly prescribed BRV patients.
- The primary objective of the study is to determine BRV retention in daily clinical practice 12 months after BRV initiation.
- The secondary objectives of the study are to determine the association between BRV retention and the following:
- Time to discontinuation of LEV, OXC, CBZ, and/or LTG (<6 months, >6 months after initiation).
- Reason for discontinuation for past use of LEV, OXC, CBZ, and/or LTG.
For specific information regarding clinical trials in the Epilepsy Division at the University of Florida contact Teri Green, RN, BSN at (352) 273- 9528.
For more general information on clinical trials click here.