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What is FAiRE?

The FAiRE program of clinical trials is exploring whether an investigational drug (ZX008) can improve seizure control in children and young adults with Dravet syndrome. FAiRE stands for “Fenfluramine Assessment in Rare Epilepsy.”

The goal of the ZX008-Study 2/1504 trials is to show that ZX008 is a safe and effective treatment for children and adolescents with Dravet syndrome when added on to their other seizure medications. The trials will look at a number of outcomes including whether people taking the study drug have:

  • A decrease in the number of convulsive (also called tonic-clonic) or non-convulsive (for example absence or focal) seizures compared to before the study medication was started
  • More days without convulsive seizures
  • Less frequent use of rescue medication
  • Less frequent hospitalizations specifically to treat seizures

Eligibility criteria include1,2

  • Age 2-18 years (inclusive)
  • Documented medical history that supports a clinical diagnosis of Dravet syndrome
  • First seizure happened in the person’s first year of life
  • Uncontrolled seizures despite current medication

How can I participate?

  • After an eligibility screening, potential participants or their caregivers record baseline seizure activity in a seizure diary for six weeks.
  • After this baseline period:
    • Potential participants in study 1501 who still meet all eligibility criteria are randomly put into one of three groups to recieve study medication for 14 weeks. In 2 of the groups, diferent doses of the study medicine will be given. People in the 3rd group will receive a placebo (a pill that does not have any expected benefit).
    • Potential participants in study 1504 who still meet all eligibility criteria are randomly put into one of two groups to recieve study medication for 14 weeks. One group will receive the study medicine; while the second group will receive a placebo (a pill that does not have any expected benefit).
    • After completing the 14-week trial period in either study, all participants will be eligible to receive the active study medication (no one receives placebo) for up to one year in an optional extension study.
  • Although some participants will recieve placebo during the 14-week trial period, ALL participants will continue taking their normal background anti-seizure medication(s) through the entire study.
  • People will be asked to use a diary to record seizure activity and medication details for 16 weeks.
  • Throughout the study, everyone will have their health checked regularly, either at their local study clinic or over the phone. These checks will vary from visit to visit, but may include electrocardiograms (ECG) (test of heart rhythms), echocardiograms (an ultrasound of the heart), physical examination (including blood pressure and heart rate), and nervous system assessments.

Are there risks?

  • Fenfluramine has been used in the past to lower appetite in obese adults, but was discontinued when some people had heart-related side effects. The participants in this trial will receive a much lower dose than what was related to the heart-related side effects. However, during this trial, regularly scheduled heart-health check ups are done to help identify any potential issues early.
  • With all trial drugs and devices, there is the chance the treatment may not help or that participants' condition could worsen.
  • The dosing plans and safety checks that are designed to protect participants are detailed in a protocol. The protocol was designed by researchers and doctors, and was reviewed by an Institutional Review Board (IRB) and the U.S. Food and Drug Administration (FDA). This protocol also includes regular safety reviews of each subject by a group of independent experts to see how the study medication is affecting each individual.

For more information on Dravet syndrome and FAiRE, or to enroll, visit https://www.faireds.com/en-us/recruitment/can-i-take-part.

1Study 2 does not allow patients taking stiripentol to participate.
2Study 1504 requires patients to be taking stiripentol as part of their current treatment regimen.