Our Clinical Trial
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 Canada, UK, Germany, France, Czech Republic and Finland.
- We are pleased to announce that a number 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 mid to late April 2017.
- Countries due to open in the coming month include Denmark, the Netherlands and Switzerland.
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, France, Canada, Germany, United Kingdom, Finland and the Czech Republic. Remaining countries Denmark, the Netherlands and Switzerland will be added in the coming weeks.
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.
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.
Patient Advisory Group
Patient Partnership and Engagement
The Patient Voice
The Patient Voice
Patient Partnership and Engagement
Anchoring the needs and perspectives of patients in trial development activities is important to Flamel. The value added through patient engagement is that it allows for clinical trial conduct that is more relevant and meaningful to the needs of patients participating in the study. To help achieve its goal of meaningful patient engagement, Flamel has partnered with the Narcolepsy Network (USA) and has established a Patient Advisory Group (PAG) for its FT218 clinical trial. The inaugural meeting for the PAG was held in April 2016 followed by a second meeting in October 2016, which was held at the annual Narcolepsy Network Conference, Orlando. A third meeting is being hosted in April 2017.
The Flamel paradigm of patient engagement has proved very successful and its continued evolution brings with it potential for extended patient engagement within clinical development frameworks beyond the life cycle of the Flamel’s FT218 clinical trial.
Founding Principals of Flamel’s PAG
- Anchoring the needs and perspectives of patients in key trial development activities
- Recognizing both the importance and critical value of a patient-centric approach in clinical trial development activities
- Promoting greater relevance and more meaningful trial design and conduct for the target patient population
- Creating greater awareness and understanding across the broader patient community on the importance of, need for and benefits of clinical research
Putting the Patient First
1. Flamel is committed to ensuring that the safety, rights and wellbeing of all study patients is a matter of organizational priority.
2. Flamel Technologies respects that clinical trial participation is entirely voluntary. Study patients can withdraw from a clinical trial at any stage time, for whatever reason and without having to justify their decision.
3. Flamel Technologies, as a matter of policy, embeds all GCP, Legal and Regulatory requirements within its operational framework to achieve research outputs which are both ethical and scientifically sound.
The following are the key best practice measures Flamel implement for clinical trial activity:
In order to ensure compliance with ethical standards the Flamel FT218 clinical trial protocol was developed in line with the “Declaration of Helsinki”, a set of ethical standards for research involving beings, human samples or identifiable data. This was devised by the World Medical Association.
The trial design was developed based on advisory from experts in the field of sleep medicine, patients and statistical experts to draw up the best possible design for this study.
Putting in place all necessary regulatory e.g. FDA clinical trial approvals before the study starts. If there is any change or if new data emerge during the clinical trial the regulatory body as well as patients will be notified as required.
Putting in place all necessary ethical approvals from the appropriate Institutional Review Board(s)(IRB)/Research Ethics Committee (REC) before the study starts. If there is any change or if new data emerge during the clinical trial the IRB/REC body is notified as required.
All clinical units and associated physicians, nurses, study coordinators, sleep technologists are pre-approved in terms of their qualification, training and experience before they can work on this study.
Both Flamel and all of its partners that work on this study will do so in accordance with all regulatory and best practice guidance and requirements.
About Flamel Ireland Limited
Flamel Ireland Limited is part of the Avadel Group of Companies. AVADEL is new and unique kind of pharmaceuticals company that changes lives through patient-focused innovation. We make medicine more meaningful.
Specializing in the optimization of compounds, we strive to develop and commercialize products that are safe, effective and easy to take, thereby helping patients adhere to their prescribed medical treatment and see better results.
Siobhan O’ Daly
Dr. Tom Roth
The third FT218 Study Patient Advisory Group meeting will be taking place April 2017.
FT218 Clinical Trial Opening in the USA March 2017.
Narcolepsy Network USA are hosting their annual awareness day for Narcolepsy March 11, 2017 – Learn more about this – http://narcolepsynetwork.org/