{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["38(12)"],"submitter":["Tepper SJ"],"funding":["Satsuma Pharmaceuticals, Inc."],"pubmed_abstract":["<h4>Background and objective</h4>STS101 is an investigational drug-device combination comprising 5.2 mg dihydroergotamine (DHE) powder (6.0 mg DHE mesylate) in a single-use nasal delivery device for the acute treatment of migraine. The primary objective of the ASCEND trial was to assess long-term safety and tolerability of STS101 in the acute treatment of migraine attacks across 12-18 months, with secondary objectives describing efficacy.<h4>Methods</h4>ASCEND was an open-label study of STS101 in adults aged 18-65 years with a ≥ 1 year history of migraine with or without aura, with onset before the age of 50 years and 4-12 migraine attacks/month and < 15 headache days/month in each of the 3 months prior to screening. Exclusion criteria included diagnosis of non-migraine headache, history o"],"journal":["CNS drugs"],"pagination":["1017-1027"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11543709"],"repository":["biostudies-literature"],"pubmed_title":["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."],"pmcid":["PMC11543709"],"pubmed_authors":["Albrecht D","Ailani J","Kirby L","Strom S","Rapoport AM","Tepper SJ"],"additional_accession":[]},"is_claimable":false,"name":"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.","description":"<h4>Background and objective</h4>STS101 is an investigational drug-device combination comprising 5.2 mg dihydroergotamine (DHE) powder (6.0 mg DHE mesylate) in a single-use nasal delivery device for the acute treatment of migraine. The primary objective of the ASCEND trial was to assess long-term safety and tolerability of STS101 in the acute treatment of migraine attacks across 12-18 months, with secondary objectives describing efficacy.<h4>Methods</h4>ASCEND was an open-label study of STS101 in adults aged 18-65 years with a ≥ 1 year history of migraine with or without aura, with onset before the age of 50 years and 4-12 migraine attacks/month and < 15 headache days/month in each of the 3 months prior to screening. Exclusion criteria included diagnosis of non-migraine headache, history o","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Dec","modification":"2026-06-03T00:50:39.256Z","creation":"2025-04-19T17:27:07.501Z"},"accession":"S-EPMC11543709","cross_references":{"pubmed":["39373843"],"doi":["10.1007/s40263-024-01118-8"]}}