A potential new treatment is being evaluated Learn more about the RESTORE open-label study for your narcolepsy patients.
Avadel is seeking patients suffering from narcolepsy, with or without cataplexy, to enroll in the RESTORE open-label study of investigational FT218 (extended-release sodium oxybate for oral suspension).
What is the RESTORE study?
RESTORE is an open-label clinical study designed to further evaluate the long-term safety and tolerability of investigational FT218, an extended-release formulation of sodium oxybate being developed for the once-nightly treatment of EDS and cataplexy in people with narcolepsy.
Avadel, a biopharmaceutical company focused on the development of FT218, is building on its previous placebo-controlled, randomized clinical trial, known as REST-ON (completed in March 2020), with RESTORE to evaluate1,2:
- 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.
Learn MoreParticipation details
Participants will take FT218 orally once per night before bed for up to 2 years at no cost. They will also visit a clinic monthly to receive FT218. Visits every third month will include checkups and completion of questionnaires. No overnight sleep studies will be required. RESTORE assessments include the following:
Efficacy
- Epworth Sleepiness Scale (ESS)*
- Sleep and Symptom Daily Diary*
- Clinical Global Impression of Improvement (CGI-I)*
- Patient Global Impression of Improvement (PGI-I)*
- Subject Preference Questionnaire on Dosing Regimen†
*REST-ON participants only.
†Switch subjects only.
Safety
- Physical examinations
- Vital signs evaluations
- Height/weight measurements
- Laboratory assessments
- Adverse event monitoring
For additional information on this study, please visit its page on clinicaltrials.gov.
Patient eligibility
To participate in RESTORE, candidates must:
- Be diagnosed with narcolepsy (with or without cataplexy)
- Be 16 years of age or older
- Be on a stable dose of twice-nightly oxybate treatment (minimum 4 weeks) OR have completed the REST-ON trial of FT218
RESTORE study site locations
There are RESTORE study sites located throughout the United States and Canada.2
- View the sites by location to determine which is closest to you
- Travel support for participants is available based on their location
Patient resources
Cataplexy Reference Guide
Use this reference guide to help educate your patients and talk to them about managing their cataplexy.
Download Cataplexy Reference GuideOpen-Label Study Information
Use this flyer to talk to your patients about participating in the RESTORE open-label study.
Download RESTORE Study InformationClinical studies from a patient’s point of view
Learn why one patient decided to participate in a narcolepsy research study, and watch as he shares his firsthand experience to help other patients who may be interested in clinical research.
Do you have questions about the RESTORE study or investigational FT218 (once-nightly sodium oxybate)? Connect with a member of Avadel’s medical team at medinfo@avadel.com.
References: 1. Avadel Pharmaceuticals announces positive topline results from its pivotal phase 3 REST-ON trial of once-nightly FT218 for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy. Avadel Pharmaceuticals. April 27, 2020. Accessed February 4, 2021. https://investors.avadel.com/news-releases/news-release-details/avadel-pharmaceuticals-announces-positive-topline-results-its. 2. An open label study of FT218 in subjects with narcolepsy (RESTORE). US National Library of Medicine. June 30, 2020. Updated January 5, 2021. Accessed February 17, 2021. https://clinicaltrials.gov/ct2/show/NCT04451668?term=NCT04451668&draw=2&rank=1 .