Trial reportHeadache2020
A Phase 1, Randomized, Open-Label, Safety, Tolerability, and Comparative Bioavailability Study of Intranasal Dihydroergotamine Powder (STS101), Intramuscular Dihydroergotamine Mesylate, and Intranasal DHE Mesylate Spray in Healthy Adult Subjects.
Trial report in Headache, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 24 citations in OpenAlex.
- Nose-brain axis: A bridge from the nasal cavity to the central nervous system.Neural regeneration research · 2026Article
- Atzumi for migraine: a new era of needle-free dihydroergotamine delivery.Annals of medicine and surgery (2012) · 2025Article
- Relationship of dihydroergotamine pharmacokinetics, clinical efficacy, and nausea-A narrative review.Headache · 2025Review
- The Pharmacokinetics of Drugs Delivered to the Upper Nasal Space.Pharmaceutical medicine · 2023Review
- Delivery of Dihydroergotamine Mesylate to the Upper Nasal Space for the Acute Treatment of Migraine: Technology in Action.Journal of aerosol medicine and pulmonary drug delivery · 2022Review
- New Approaches to Shifting the Migraine Treatment Paradigm.Frontiers in pain research (Lausanne, Switzerland) · 2022Review
- Nasal Delivery of Acute Medications for Migraine: The Upper Versus Lower Nasal Space.Journal of clinical medicine · 2021Review
- Headache Medicine Grand Challenge: Headache: A New Frontier, A New Challenge.Frontiers in pain research (Lausanne, Switzerland) · 2021Article
- Transmucosal drug administration as an alternative route in palliative and end-of-life care during the COVID-19 pandemic.Advanced drug delivery reviews · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
Abstract
objectiveTo investigate and compare the safety and the pharmacokinetics of dihydroergotamine (DHE) after administration of intranasal DHE powder (STS101), intranasal DHE spray (Migranal
methodsThis was a 2-part, active-controlled, 3-period crossover study over 3 weeks, separated by 1-week washout periods. In part 1, 3 ascending dosage strengths of STS101 (1.3, 2.6, and 5.2 mg) were administered to 15 healthy subjects with no history of migraine. In part 2, 27 healthy subjects were administered 1 dose each of STS101 5.2 mg, Migranal DHE Mesylate Liquid Nasal Spray 2.0 mg, and IM DHE Mesylate 1.0 mg in a randomized order. Liquid chromatography, tandem mass spectrometry was used to determine plasma levels of DHE and its major metabolite, 8'OH-DHE. Pharmacokinetic parameters (C
resultsForty-three subjects were enrolled and received study medication. Forty completed all study activities, 14 in part 1 and 26 in part 2. In part 1, DHE plasma levels showed a dose-dependent increase, with STS101 5.2 mg reaching a mean C
conclusionSTS101 showed rapid absorption, achieving effective DHE plasma concentrations within 10 minutes. It achieved substantially higher C
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.