Having trouble managing your narcolepsy symptoms? Learn more about the RESTORE open-label study evaluating a new potential treatment.
RESTORE is an open-label clinical study evaluating the long-term safety and tolerability of FT218, an investigational extended-release formulation of sodium oxybate currently being developed for the once-nightly treatment of excessive daytime sleepiness (EDS) and cataplexy in people with narcolepsy. An open-label clinical study means that everyone who takes part receives the medication. RESTORE, which builds on a previous clinical trial, known as REST-ON, is primarily studying:
- The long-term safety, tolerability, and efficacy of FT218
- The dosing and tolerability in switching from twice-nightly sodium oxybate to FT218
An additional objective is to evaluate the patient preference between once-nightly and twice-nightly dosing regimens of sodium oxybate. RESTORE is open to people with narcolepsy currently on twice-nightly sodium oxybate or people who completed the REST-ON trial of FT218.
RESTORE is an important opportunity to help doctors better understand how this investigational medication works for people with narcolepsy. Participation will include:
- Taking FT218 once nightly for up to 2 years at no cost
- Visiting a clinic monthly to receive FT218; every third month will include checkups and completion of questionnaires
*RESTORE study checkups will measure narcolepsy symptoms such as EDS and cataplexy, as well as how you’re doing overall. No overnight sleep studies will be required for RESTORE.
Am I eligible?
To participate in RESTORE, candidates must:
- Be diagnosed with narcolepsy (with or without cataplexy)
- Be 16 years of age or older
- Be currently on a stable dose of twice-nightly oxybate (minimum 4 weeks) OR have completed the REST-ON trial of FT218
RESTORE study site locations
There are RESTORE open-label study sites located throughout the continental United States and Canada.
- Check the study sites by location to determine which is closest to you
- Travel support for participants may be available based on where you live
How can I get involved?
Cataplexy Reference Guide
Use this reference guide to learn more about cataplexy and talk to your doctor to better manage your symptoms.Download Cataplexy Reference Guide
Talk to Your Doctor Sheet
Use this flyer to talk to your doctor about the RESTORE study and decide if participating could be a good option for you.Download Talk to Your Doctor Sheet
Is the RESTORE study right for you?
Hear firsthand from another person with narcolepsy, and learn why he chose to participate in a clinical study.
Do you know someone with narcolepsy who may be interested in the RESTORE study? Click below to send them a link.Share