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• W4367304328 abstract "<h3>Objective:</h3> To assess patients’ impression and satisfaction with STS101 in a long-term, open-label safety study. <h3>Background:</h3> The ASCEND trial assessed the safety and tolerability of STS101 5.2 mg (dihydroergotamine nasal powder) in the acute treatment of migraine with/without aura over 12 months. STS101 is a novel investigational product for rapid and easy nasal delivery. <h3>Design/Methods:</h3> ASCEND (NCT04406649) is a multi-center, multiple-dose, open-label study in 344 adults (18–65 years) with migraine. Participants self-administered STS101 for ≤2 doses/24 hours and ≤12 doses/month for 12 months. Patient global impression, ease-of-use impression, patient likelihood of use, and comparison of study medication with previously used migraine medication were collected at 3-,6-, and 12-month time points and analyzed in the modified intent-to-treat population. All questions were assessed using a 5-point verbal Likert scale. <h3>Results:</h3> At 3 and 12 months, 90.7% (262/289) and 88.5% (108/122) of subjects agreed that STS101 was easy/very easy to use. In comparison to their usual medication, most participants at 3 and 12 months agreed/strongly agreed that they returned to normal faster (66.2% [188/284]; 64.7% [183/283]) and that STS101 kept their migraine from returning (62.2% [176/283]; 66.7% [80/120]), more consistently treated migraine (70.4% [200/284]; 73.6% [89/121]), and worked faster (64.7% [183/283]; 70.0% [84/120]. Subjects indicated they would be likely/very likely to use STS101 if available (75.8% [219/289]; 77.0% [94/122]). Over 80% of subjects reported a good/very good impression of STS101 at each time point (3 months, 83.8% [243/290]; 12 months, 91.0% [111/122]). <h3>Conclusions:</h3> Subject impression data through 12 months suggest that STS101 was perceived very favorably by subjects on multiple measures, including in comparison to their usual migraine medications. <b>Disclosure:</b> Dr. Ailani has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Allergan/Abbvie. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen. Dr. Ailani has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Eli Lilly. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck/Alder. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Impel. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nesos. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GlaxoSmithKline. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BiodeliveryScienceIndustry. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Miravo. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Pfizer. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Impel. Dr. Ailani has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Satsuma. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lindpharma. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Current Pain and Headache Report. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Neurology Live. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Medscape. Dr. Ailani has stock in Ctrl M. The institution of Dr. Ailani has received research support from Allergan/Abbvie. The institution of Dr. Ailani has received research support from Eli Lilly. The institution of Dr. Ailani has received research support from Zosano. Dr. Ailani has received research support from Satsuma. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Advisory Panel with Medscape. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Medical Advisor with SELF. Dr. Charleston has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan/AbbVie. Dr. Charleston has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biohaven Biopharmaceuticals. Dr. Charleston has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alder Biopharmaceuticals. Dr. Charleston has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva Pharmaceuticals. Dr. Charleston has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal Pharmaceuticals. Dr. Charleston has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma Pharmaceuticals. Dr. Charleston has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Vaccine Injury Compensation Program. Dr. Charleston has a non-compensated relationship as a Associate Editor with Headache Journal: The Journal of Head and Face Pain that is relevant to AAN interests or activities. Dr. Charleston has a non-compensated relationship as a Board Member at Large with Alliance for Headache Disorders Advocacy that is relevant to AAN interests or activities. Detlef Albrecht has received personal compensation for serving as an employee of Satsuma. Detlef Albrecht has stock in Satsuma." @default.
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• W4367304328 date "2023-04-25" @default.
• W4367304328 modified "2023-09-25" @default.
• W4367304328 title "Interim Analysis of Subject Impression Data for STS101 From the Phase 3 Open-Label ASCEND Study (P13-12.003)" @default.
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