A Phase 1 interventional study of Dihydroergotamine and Dihydroergotamine in Migraine, Migraine With Aura and Migraine Without Aura, sponsored by Satsuma Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-20.
Sponsored by Satsuma Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
Single-center, single-dose, open-label, 5-period crossover (in each part), pharmacokinetic and safety study.
36 subjects received a single dose of STS101, 1.0 mg DHE mesylate IM injection, and 2 mg DHE mesylate nasal spray in a randomized, 5-period crossover manner.
1,558 studies on the registry are indexed under Migraine Disorders; 301 are open to participants now.
This study's enrollment of 36 is below the median of 80 across 1,197 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Satsuma Pharmaceuticals, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Exclusion Criteria:
STS101 (dihydroergotamine nasal powder), 5.2 mg
Drug: Dihydroergotamine
STS101 (dihydroergotamine nasal powder), 7.0 mg
Drug: Dihydroergotamine
STS101 (dihydroergotamine nasal powder), 8.6 mg
Drug: Dihydroergotamine
Dihydroergotamine mesylate
Drug: Dihydroergotamine
Dihydroergotamine mesylate
Drug: Dihydroergotamine
Dihydroergotamine intranasal powder
Also known as: Dihydroergotamine Mesylate
Dihydroergotamine intramuscular injection
Also known as: Dihydroergotamine Mesylate
Dihydroergotamine intranasal spray
Also known as: Dihydroergotamine Mesylate
DHE Relative Bioavailability
The relative bioavailability of STS101 5.2, 7.0, and 8.6 mg (test treatments) to 1.0 mg DHE mesylate IM injection (reference treatment) and to 2.0 mg DHE mesylate IN spray (reference treatment) was assessed on the basis of dose-corrected Cmax.
Time frame: Pre-dose through 48 hours Post-Dose
DHE Comparative Bioavailability
The comparative bioavailability STS101 5.2, 7.0, and 8.6 mg (test treatments) to 1.0 mg DHE mesylate IM injection (reference treatment) and to 2.0 mg DHE mesylate IN spray (reference treatment) was assessed on the basis of Cmax .
Time frame: Pre-dose through 48 hours Post-Dose
Serious Adverse Events
To assess the safety profile through examination of serious adverse events of single doses of STS101; 1 mg DHE administered by intramuscular injection, and 2 mg DHE administered as nasal spray
Time frame: Pre-dose through 48 hours Post-Dose
Treatment-Related Adverse Events
To assess the safety profile through examination of treatment-related adverse events of single doses of STS101; 1 mg DHE administered by intramuscular injection, and 2 mg DHE administered as nasal spray
Time frame: Pre-dose through 48 hours Post-Dose
Plan to share: No
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dihydroergotamine
Satsuma Pharmaceuticals, Inc.