Zogenix is a pharmaceutical company that was founded in 2006 and is committed to providing innovative treatments for people living with rare and burdensome diseases that affect the central nervous system, such as Dravet syndrome – Zogenix is working with dedicated scientific and medical experts, each of whom share a collective passion for making a difference in the lives of patients they serve.

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ABOUT DRAVET SYNDROME

Dravet syndrome (sometimes called severe myoclonic epilepsy of infancy or SMEI) is a debilitating form of epilepsy that begins in infancy. The condition is very rare, affecting only 1 in every 20,000-40,000 births and can result in:

  • Seizures
  • Behavioral and developmental problems
  • Movement and balance issues
  • Language and speech problems
  • Growth issues
  • Sleeping difficulties
  • Frequent infections
  • Nervous system problems

Certain anti-seizure medications have helped some children and young adults reduce the number of seizures they have. But they don’t work for everyone. That’s why studies (like those in the FAiRE program) are so important.

ABOUT CLINICAL RESEARCH

Clinical studies (also known as ‘clinical trials’) help researchers test new medications and improve (or test new uses for) those that are already available. They do this by asking participants to follow strict dosing plans and then comparing the results.

In this way, researchers can answer questions such as:

  • Does this investigational drug work?
  • Does it work better than another medicine already available?
  • Does it cause any side effects?

These dosing plans and questions are laid out in the study’s ‘protocol’. A large group of people (including doctors, researchers and other specialists) review this protocol before the study begins. It is their job to protect the safety of participants. But the exact risks of a study can be hard to predict. So participants must agree to a schedule of clinic visits and/or telephone appointments so that the study team can monitor their health and learn how their dosing plan is affecting them.

ABOUT FAiRE

In brief

Has your son or daughter been diagnosed with Dravet syndrome? Are they still having uncontrolled seizures despite current medication? Then you may be interested in FAiRE (Fenfluramine Assessment in Rare Epilepsy) – a program of clinical studies that will ask if an investigational drug called ZX008 can improve seizure control in children and young adults with Dravet syndrome.

The FAiRE studies will try to answer questions about ZX008 such as:

  • Can it reduce the number of seizures when given alongside other anti-seizure medications?
  • Does it cause any side effects?

Can I take part?

Length

Participants may join study 1501, 1502, or 1504. Each of these studies will try to answer a different question:

  • Participation in studies 1501 and 1502 lasts for up to 22 weeks
  • Participation in study 1504 lasts for up to 26 weeks

Can I take part?

Medication

To help researchers learn about ZX008 (low-dose fenfluramine), participants will be given a dosing plan to follow for a set amount of time. These dosing plans will differ between studies.

Studies 1501 and 1502

Participants will randomly (by chance) receive:

ZX008 for up to 16 weeks
OR
A placebo (a ‘dummy’ drug) for up to 16 weeks

Participants will be 2 times more likely to receive ZX008 (at one of two different doses) than a placebo.

Study 1504

Participants will randomly (by chance) receive:

ZX008 plus other study medication for up to 19 weeks
OR
A placebo plus other study medication for up to 19 weeks

Participants have an equal chance of receiving either ZX008 or a placebo.

All participants will continue to take their existing anti-seizure medication(s) throughout the study.

Studies 1501 and 1502 Study 1504

Participants will randomly (by chance) receive:

ZX008 for up to 16 weeks
OR
A placebo (a ‘dummy’ drug) for up to 16 weeks

Participants will be 2 times more likely to receive ZX008 (at one of two different doses) than a placebo.

Participants will randomly (by chance) receive:

ZX008 plus other study medication for up to 19 weeks
OR
A placebo plus other study medication for up to 19 weeks

Participants have an equal chance of receiving either ZX008 or a placebo.

All participants will continue to take their existing anti-seizure medication(s) throughout the study.

Why is this study being conducted?

ZX008 is solution of low-dose fenfluramine taken by mouth.

In the past, higher doses of fenfluramine were approved for obese adults as an appetite suppressant. But it was withdrawn because some people developed serious heart-related side effects. However, ZX008 is a low-dose formulation of fenfluramine. Several children have been treated with low-dose fenfluramine to date (some for up to 26 years). Of those, the majority have experienced no signs or symptoms of heart disease. But the FAiRE program of studies includes an extensive heart-monitoring plan to help identify any early signs of heart-related side effects.

Can I take part?

Health checks

All participants will have their health checked regularly. This will be done at the study clinic and over the telephone. During the clinic visits, a study doctor will carry out a range of assessments and lab tests. These will differ from visit to visit, but may include:

  • Electrocardiograms (a painless recording of the heart’s electrical activity)
  • Echocardiograms (a painless ultrasound of the heart – to monitor for any heart-related side effects)
  • Vital signs checks (heart rate, breathing rate, pulse and temperature)
  • Physical examinations
  • Nervous system assessments.

Can I take part?

Follow-up

After their final dose, participants will enter a follow-up period. This allows the study team to monitor their health and record what happens once they come to the end of their dosing plan.

Some participants may also be given the option to join an extension study instead of entering the follow-up period. During the extension study, all participants will take ZX008 – even those given a placebo before.

Can I take part?