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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STS101 5.2 mg | Experimental | STS101 (dihydroergotamine nasal powder), 5.2 mg |
|
| STS101 7.0 mg | Experimental | STS101 (dihydroergotamine nasal powder), 7.0 mg |
|
| STS101 8.6 mg | Experimental | STS101 (dihydroergotamine nasal powder), 8.6 mg |
|
| DHE intramuscular injection | Active Comparator | Dihydroergotamine mesylate |
|
| DHE nasal spray | Active Comparator | Dihydroergotamine mesylate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dihydroergotamine | Drug | Dihydroergotamine intranasal powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 . | Pre-dose through 48 hours Post-Dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Pre-dose through 48 hours Post-Dose |
| Treatment-Related Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Levy, MD | Quotient Sciences Miami Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences Miami Inc. | Miami | Florida | 33126 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38413540 | Derived | Lipton RB, Albrecht D, Bermudez M, Hu J, Hussey E, Levy J. A randomized, open-label, 5-period crossover study evaluating the pharmacokinetics and safety of a single dose of intranasal dihydroergotamine (DHE) powder (STS101), intramuscular DHE mesylate, and liquid nasal spray DHE in healthy adults. Headache. 2024 Mar;64(3):266-275. doi: 10.1111/head.14685. Epub 2024 Feb 27. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D020325 | Migraine with Aura |
| D020326 | Migraine without Aura |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D004087 | Dihydroergotamine |
| ID | Term |
|---|---|
| D004879 | Ergotamines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Dihydroergotamine | Drug | Dihydroergotamine intramuscular injection |
|
|
| Dihydroergotamine | Drug | Dihydroergotamine intranasal spray |
|
|
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 |
| Pre-dose through 48 hours Post-Dose |
| D009422 | Nervous System Diseases |
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |