The LGS Study

LIVING WITH LGS...

Find out more about the FAiRE research study for Lennox-Gastaut syndrome (LGS).

Progress
Butterfly

ABOUT THE FAiRE LGS STUDY

Lennox-Gastaut syndrome (LGS) is a rare and severe form of epilepsy that is very difficult to treat. Although approved medications for LGS exist, many patients still struggle to manage their seizures and are in need of new and more effective treatment options.

The FAiRE LGS research study is trying to meet this need by determining whether a low-dose of a drug called ZX008 is safe and effective compared to placebo (a look-a-like that contains no active medicine) in controlling seizures that result in falls in children and adults with LGS.

This study will track seizure frequency, measure exposure to the drug, and also evaluate whether the the drug has an impact on other, non-seizure related aspects of the condition, such as overall quality of life.

The FAiRE-LGS study is divided into 2 parts:
  • Part 1: Participants will receive either ZX008 or placebo. This part will last approximately 20 weeks and include 6 office visits and 6 phone calls.
  • Part 2: All participants receive ZX008. This part will last up to 54 weeks and include approximately 7 office visits and 1 phone call.During both parts, participants will be expected to take the study medication twice a day - in addition to their current anti-epileptic treatment(s) - and to complete an electronic diary that documents seizures every day.
Medication:

The investigational drug is low dose fenfluramine hydrochloride solution (ZX008), taken by mouth twice a day, with or without food.

Health checks:

During clinic visits, the study team will perform a range of assessments and laboratory tests. These will differ from visit to visit but may include:

  • Electrocardiograms (ECG, a painless recording of the heart’s electrical activity)
  • Echocardiograms (ECHO, a painless ultrasound of the heart – to monitor for any heart-related side effects)
  • Vital signs checks (heart rate, breathing rate, pulse and temperature)
  • Blood tests
  • Physical examinations
  • Nervous system assessments
  • Questionnaires about cognition, behavior, and quality of life
Follow-up:

Participants that complete or leave the study will be asked to come in for a follow-up visit a couple of weeks after the last dose is taken. Participants will also be asked to come in for additional cardiac safety follow-up visits in the months after receiving the last dose of study medication.

Can I Take Part?
Child

JOIN THE MAILING LIST

Keep up-to-date with the latest news about the FAiRE program.

Sign Up