Rare Epilepsy Study (Dravet Syndrome) – Now Enrolling
FAiRE (Fenfluramine Assessment in Rare Epilepsy)
FAiRE (Fenfluramine Assessment in Rare Epilepsy) is a program of clinical studies that will assess whether an investigational drug called ZX008 can reduce the number of seizures experienced by children and young adults who:
Dravet syndrome is a debilitating form of epilepsy for which there is no cure. Doctors can prescribe anti-seizure medications to help, but some children and young adults still struggle to manage their condition. So the FAiRE studies will assess whether ZX008 can reduce the number of seizures when given in combination with other anti-seizure medications.
Eligible (suitable) participants will be given a dosing plan to follow that will include taking either ZX008 or a placebo (a lookalike that contains no active medicine) twice a day. Although dosing plans vary depending on the study joined, all participants will take ZX008 or a placebo in combination with other anti-seizure medications. The study team will discuss these differences in detail with potential participants and their families to ensure they join the right study for them.
Participation will last for up to 22 or 26 weeks (including screening and follow-up visits) depending on which study participants join. This is because the dosing and follow-up periods vary between studies. After a participant finishes taking part, they may choose to join an extension study. All extension study participants will receive ZX008.
If you, your family member or loved one is interested in learning more about participating in this study, please contact the Study Coordinator at 520-320-2157.