About the FAiRE Program

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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.

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DRAVET SYNDROME (DS)

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)
LENNOX-GASTAUT SYNDROME (LGS)

FAiRE LGS studies are currently open for enrollment. These studies include:

  • 1601 A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS
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ZX008

ZX008 is a low-dose formulation of fenfluramine taken by mouth twice a day, with or without food. Fenfluramine was marketed in the past as an appetite suppressant for obese adults and was used at higher doses than this study. It was withdrawn from the market in 1997 because some people developed serious heart-related side effects.

However, the doses used in the FAiRE program are 2 to 4 times lower than the previously marketed doses. To date more than 300 individuals with epilepsy have been treated with ZX008, some for over 25 years, and none have experienced any signs or symptoms of heart valve disease or pulmonary hypertension. Importantly, all study participants will be screened to ensure no pre-existing heart conditions are present, and the study includes an extensive heart-monitoring plan to help identify any early signs of heart-related side effects.

In each FAiRE study, participants will be given a dosing plan to follow for the duration of study participation. These dosing plans will differ between studies, but all participants will continue to take their existing anti-seizure medication(s) normally.

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