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A Phase I, Three-Period, Three-Way, Randomized, Open-Label, Single-Dose, Cross-Over, Comparative Bioavailability Study of Dihydroergotamine Mesylate (DHE) Administered by I123 Precision Olfactory Delivery (PODTM) Device Nasal Spray, DHE for Injection (Intravenous), and Migranal Nasal Spray in Healthy Adult Subjects

Trial Profile

A Phase I, Three-Period, Three-Way, Randomized, Open-Label, Single-Dose, Cross-Over, Comparative Bioavailability Study of Dihydroergotamine Mesylate (DHE) Administered by I123 Precision Olfactory Delivery (PODTM) Device Nasal Spray, DHE for Injection (Intravenous), and Migranal Nasal Spray in Healthy Adult Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 20 Jun 2023

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At a glance

  • Drugs Dihydroergotamine mesilate (Primary) ; Dihydroergotamine mesilate (Primary)
  • Indications Migraine
  • Focus Pharmacokinetics; Proof of concept
  • Acronyms STOP 101
  • Sponsors Impel NeuroPharma; Impel Pharmaceuticals
  • Most Recent Events

    • 15 Jun 2023 According to an Impel Pharmaceuticals media release, data from this study will be presented at the 65th Annual Scientific Meeting of the American Headache Society (AHS), taking place June 15-18, 2023, in Austin, Texas.
    • 01 May 2020 Results of a PK analysis comparing plasma exposure of different marketed formulations of dihydroergotamine mesylate using data from STOP 101 study and literature reports presented at the 72nd Annual Meeting of the American Academy of Neurology
    • 20 Nov 2019 Results published in the Impel NeuroPharma Media Release.
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