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Authors
Tepper, Stewart J. https://orcid.org/0000-0002-9879-6638
Albrecht, Detlef https://orcid.org/0009-0009-8702-8199
Ailani, Jessica https://orcid.org/0000-0001-8106-4927
Kirby, Louis
Strom, Shannon
Rapoport, Alan M. https://orcid.org/0000-0002-6311-8562
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Clinical Trials BETA
Clinical trials referenced in this document:
nct04406649 at ClinicalTrials.govDocuments that mention this clinical trial
Long-Term (12-Month) Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine: Data from the Phase 3 Open-Label ASCEND Study
https://doi.org/10.1007/s40263-024-01118-8
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Funding
Funding for this research was provided by:
Satsuma Pharmaceuticals, Inc.
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Article History
Accepted: 14 August 2024
First Online: 7 October 2024
Declarations
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: This study was funded by Satsuma Pharmaceuticals, Inc.
: S.J.T. holds grants for research (no personal compensation) for Allergan/AbbVie, Amgen, Eli Lilly, Lundbeck, Neurolief, Novartis, Satsuma, Zosano; is an advisor (honoraria) for Aeon, Allergan/AbbVie, Alphasights, Amgen, Aruene, Atheneum, Axsome Therapeutics, Becker Pharmaceutical Consulting, BioDelivery Sciences International, Biohaven, ClearView Healthcare Partners, ClickTherapeutics, CoolTech, CRG, Decision Resources, Defined Health, DRG, Eli Lilly, ExpertConnect, FCB Health, Fenix, GLG, Guidepoint Global, Health Advances, Health Science Communications, HMP Communications, Impel, Initiator Pharma, InteractiveForums, Keyquest, Ki Health Partners, Krog and Partners, Lundbeck, M3 Global Research, Magnolia Innovation, MJH Holdings, Miravo Healthcare, Neurofront Therapeutics, Neurolief, Novartis, P Value Communications, Pain Insights, Inc, Palion Medical, Pulmatrix, Putnam Associates, Rehaler, SAI MedPartners, Satsuma, Slingshot Insights, Spherix Global Insights, Strategy Inc, Synapse Medical Communication, System Analytic, Taylor and Francis, Tegus, Teva, Theranica, Tremeau, Trinity Partners, Unity HA, Vial, XOC, and Zosano; receives a salary from Dartmouth-Hitchcock Medical Center and Thomas Jefferson University; and has CME honoraria from the American Academy of Neurology, American Headache Society, Annenberg Center for Health Sciences, Catamount Medical Education, Diamond Headache Clinic, Forefront Collaborative, Haymarket Medical Education, HMP Global, Medical Education Speakers Network, Medical Learning Institute Peerview, Migraine Association of Ireland, Miller Medical Education, National Association for Continuing Education, North American Center for CME, The Ohio State University, Physicians’ Education Resource, PlatformQ Education, Primed, Vindico Medical Education, and WebMD/Medscape. D.A. was an employee and stockholder of Satsuma at the time of study conduct and is now a consultant for Satsuma. J.A. is an advisor for AbbVie, Amgen, Aeon, Axsome, Biohaven, BioDelivery Scientific International, Eli Lilly, GlaxoSmithKline, Lundbeck, Linpharma, Impel, Miravio, Pfizer, Neurolief, Satsuma, Teva, and Theranica; holds clinical trial grants from AbbVie, Biohaven, Eli Lilly, Satsuma, and Zosano; has stock options in CtrlM; and is on the editorial boards or steering committee for <i>Current Pain and Headache Reports</i>, <i>Medscape</i>, <i>NeurologyLive</i>, and <i>SELF</i> magazine. L.K. was a consulting medical monitor for Satsuma at the time of the study conduct but owns no shares of Satsuma. His clients include Advarra Consulting, Clinilabs, Q Therapeutics, Thievon-Wright consulting, and Worldwide Clinical Trials. He sits on the advisory boards of Alzheon, INDRC, and Reservoir Pharma. S.S. is an employee of Satsuma and was a stockholder at the time of study conduct. A.M.R. is an advisor for AbbVie, Biohaven, Cala Health, Doctor Reddy’s, Eli Lilly, Pfizer, Satsuma, Teva, Theranica, and Zosano; he is on the speaker’s bureau of AbbVie, Biohaven, Doctor Reddy’s, Lundbeck, Pfizer, and Teva; is the Editor-in-Chief of <i>Neurology Reviews</i>; and is on the editorial board of <i>CNS Drugs</i>. A.M.R. was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions.
: The protocol was approved by the central institutional review board (Advarra) and/or the ethics committee or institutional review board of each study center.
: All participants provided written informed consent.
: Not applicable.
: Not applicable.
: The data that support the findings of this study are available from the corresponding author (D.A.) upon reasonable request.
: All authors made substantial contributions to the conception and design of the work and the interpretation of the data. The study statistician, Shelia Ligozio, performed the data analyses. All authors participated in the drafting and revising of the manuscript. All authors read and approved the final manuscript.
