FAiRE (Fenfluramine Assessment in Rare Epilepsy) is a program of clinical studies that are evaluating whether an investigational drug called ZX008, when taken in addition to current anti-epileptic treatments, can improve seizure control in children and young adults with rare epilepsies, such as Dravet syndrome and Lennox-Gastaut syndrome. Each study tracks seizure frequency, measures exposure to the drug, and assesses non-seizure related aspects of the condition, such as quality of life. Additionally, all participants will have their health checked regularly, both in person and over the telephone.
FAiRE DS studies are currently closed for enrollment. These studies include:
- 1501/1502 A Multicenter, Randomized, Double-blind, Parallel Group, Placebo- controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome
- 1503 An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome
- 1504 A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2)