January 19, 2017

Flamel’s Once Nightly Sodium Oxybate Clinical Trial: REST-ON

On this page you will:

Learn More about our Clinical Trial &

Find a trial site

Flamel’s “REST-ON” study is a Phase III clinical trial with an investigational  study drug named FT218,. FT218 is an extended-release oral suspension of sodium oxybate. Flamel is looking for subjects to participate in the REST-ON clinical trial, which will evaluate the safety and efficacy of their once nightly sodium oxybate for the treatment of excessive daytime sleepiness (EDS) and cataplexy in patients with narcolepsy.

FT218 is dosed once at bedtime unlike the currently marketed formulation of sodium oxybate (Xyrem®) which needs to be taken twice nightly, once at bedtime and then again 2.5 – 4 hours later.

Patients with a diagnosis of narcolepsy who meet the study criteria may be eligible to participate in our clinical trial.

  • The study is currently open and recruiting patients in the USA, Canada, UK, Germany, France, Czech Republic, Finland, Denmark, the Netherlands and Switzerland.
  • We are pleased to announce that the majority of USA study sites are now open, the list of open USA sites can be found by visiting the Link2Trials web-site, see link to this web-site below. It is anticipated that all remaining USA sleep center study sites will be open by the end of April.

Which sleep centers are participating in the study, and how can I contact the sleep center to see if I am eligible to participate?

  • Flamel is working with a partner company called Link2Trials, which has created country specific web-sites where you can learn more about the trial and participating centers.
  • On the web-site you will be able to see which sleep centers are participating in the study and which is closest to you.
  • You will also have the option of completing a questionnaire to assess if you might be eligible to participate in the study. If you are, you can opt to have your information sent to the sleep center closest to you. Someone from the sleep center will then contact you to discuss your potential participation in the study.

The Link2Trials country specific web-sites are active for the USA, Canada, France, Germany, United Kingdom, Finland and the Czech Republic, Denmark, Switzerland and the Netherlands.

You can visit the Country Specific Link2Trials web-site by clicking on the following links:

Alternatively, you can find a list of all participating study sites in the United States, Canada and Europe posted under the tab “Participating Countries & Study Sites” on this web-site.

More about REST-ON:

A Randomized Study Evaluating the Efficacy and SafTey of a Once Nightly Formulation of Sodium Oxybate

Flamel’s extended release oral suspension of sodium oxybate (FT218) has not yet been approved for use by the FDA. Before it can be marketed, Flamel must complete a clinical trial to establish how safe and effective this new formulation is. Flamel has received approval from the FDA, Health Canada and regulatory bodies in certain European countries to conduct this clinical trial.  It is currently recruiting patients in Canada, USA, UK, Germany, France, Czech Republic and Finland, Denmark, the Netherlands and Switzerland.

The investigational drug (FT218) is a controlled release oral suspension of sodium oxybate and only has to be taken once nightly. Because it is an investigational drug that has not yet been approved by the FDA, the study must be done according to best practice guidance from the FDA.   This means that the investigational drug (FT218) will be compared to placebo. A placebo controlled trial design provides the highest level of evidence on the efficacy and safety of a drug in development. A placebo is a treatment that does not contain any active substance. By comparing people’s responses to placebo and FT218, Flamel is better able to test and understand what benefits FT218 may have in reducing symptoms of narcolepsy.

Importantly, if you are currently taking medication for your daytime sleepiness you will be allowed to continue this during the trial.  The study doctor will provide you with necessary explanations about the study, the placebo design and what this means in the context of your overall treatment for narcolepsy.

What happens if I am eligible to participate in the FT218 Clinical Trial?

If you are determined to be eligible by your study doctor, and if you wish to participate, you will sign an informed consent form. Informed consent is a learning process for patients, during which key facts about the clinical trial will be explained to you. This is all done before you decide whether or not you wish to participate.  If you do decide to participate you will be closely monitored by the study doctor and his/her clinical team.

You do not have to participate in this study if you do not want to. If you do decide to participate, you can exit the study at any time without having to give a reason. This will not affect the standard of care you are currently receiving from your doctor.