Roth, Thomas
Dauvilliers, Yves
Thorpy, Michael J.
Kushida, Clete
Corser, Bruce C.
Bogan, Richard
Rosenberg, Russell
Dubow, Jordan
Seiden, David http://orcid.org/0000-0002-6548-2042
Clinical trials referenced in this document:
Documents that mention this clinical trial
Effect of FT218, a Once-Nightly Sodium Oxybate Formulation, on Disrupted Nighttime Sleep in Patients with Narcolepsy: Results from the Randomized Phase III REST-ON Trial
https://doi.org/10.1007/s40263-022-00904-6
Funding for this research was provided by:
Avadel Pharmaceuticals
Article History
Accepted: 23 January 2022
First Online: 5 April 2022
Declarations
:
: This study was funded by Avadel Ireland. Avadel was involved in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. Open access publication was funded by Avadel Ireland.
: TR is a consultant for Jazz Pharmaceuticals, Takeda Pharmaceutical Co., Orexo, Avadel Pharmaceuticals, Eisai, Merck & Co., and Idorsia. YD has served as a consultant or on advisory boards for Avadel Pharmaceuticals, Jazz Pharmaceuticals, UCB, Takeda Pharmaceutical Co., Theranexus, Harmony Biosciences, Bioprojet Pharma, and Idorsia. MJT has served as a consultant or on advisory boards for Axsome Therapeutics, Balance Therapeutics, Eisai, Avadel Pharmaceuticals, Harmony Biosciences, Jazz Pharmaceuticals, NLS Pharmaceuticals, Suven Life Sciences Ltd., and Takeda Pharmaceutical Co. CK is a consultant of Avadel Pharmaceuticals and XW Pharma. BCC is a member of the speakers bureaus and has received honoraria from Jazz Pharmaceuticals, Eisai, and Harmony Biosciences. He is an advisor and has received consulting fees and honoraria from Jazz Pharmaceuticals, Eisai, Harmony Biosciences, and Avadel Pharmaceuticals. He is a member of the speakers bureau for Merck & Co. Inc., Jazz Pharmaceuticals, Eisai, and Harmony Biosciences. RB is a shareholder in WaterMark Medical and Healthy Humming, LLC; serves on the board of directors for the National Sleep Foundation and WaterMark Medical; is a consultant for Jazz Pharmaceuticals, Takeda Pharmaceutical Co., Avadel Pharmaceuticals, and Oventus; has received industry-funded research grants from Avadel Pharmaceuticals, BrescoTec, Bayer, Idorsia, Suven Life Sciences Ltd, Jazz Pharmaceuticals, Balance, Vanda, Merck & Co., Eisai, Philips, FRESCA Medical, Takeda Pharmaceutical Co., LivaNova, Roche, and Sommetrics; and has served on speakers bureaus for Jazz Pharmaceuticals, Eisai, and Harmony Biosciences. RR received research grant funding by Avadel Pharmaceuticals to conduct the current study. He has also received research grant support from Jazz Pharmaceuticals, Eisai, Merck & Co., Apnimed, Inc., Idorsia, Biohaven, and Suven Life Sciences Ltd. He has participated in advisory boards for Jazz Pharmaceuticals, Eisai, and Harmony Biosciences. DS is an employee of Avadel Pharmaceuticals. JD is a consultant to, stockholder, and former employee of Avadel Pharmaceuticals.
: The REST-ON protocol was approved by the centers’ institutional review board or appropriate independent ethics committee.
: All participants provided written informed consent (and assent for participants aged 16 or 17 years of age) before participation.
: Not applicable.
: The data underlying this article will be shared on reasonable request to the corresponding author.
: Not applicable.
: TR, YD, JD, and DS participated in study conception and design. TR, YD, CK, MJT, BCC, RB, RR, JD, and DS participated in the acquisition and/or analysis of data. TR, YD, CK, MJT, BCC, RB, RR, JD, and DS participated in drafting a significant portion of the manuscript or figures, approved the final version for submission, and agree to be accountable for the work presented.