MigrainePhase 1NCT05337254
A Study of the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects
A Phase 1 study testing Dihydroergotamine in people with Migraine and Migraine With Aura, run by Satsuma Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
Single-center, single-dose, open-label, 5-period crossover (in each part), pharmacokinetic and safety study. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine, Migraine With Aura, Migraine Without Aura
- What is being tested?
- Dihydroergotamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2021to 4 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 50 years of age at the time of enrollment.
- Signed the informed consent document.
- Subject judged to be healthy by a qualified physician
Who cannot join
- Abnormal physical findings of clinical significance at the screening examination
- Significant abnormal laboratory values at the Screening Visit.
- Clinically significant symptoms or conditions that may have placed the subject at an unacceptable risk as a participant in the trial, or that may have interfered with the absorption, distribution, metabolism or excretion of the IMP.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, 5-Period Crossover Study to Evaluate the PK, Bioavailability, Safety, and Tolerability of Single Doses of STS101, DHE IM Injection and DHE Nasal Spray in Healthy Adult Subjects
Single-center, single-dose, open-label, 5-period crossover (in each part), pharmacokinetic and safety study.
Read the detailed description
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.
- Conditions
- Migraine, Migraine With Aura, Migraine Without Aura
- Being tested
- Dihydroergotamine
- Keywords
- dihydroergotamine, dihydroergotamine mesylate, migraine
- Medical subject headings
- Migraine Disorders, Migraine with Aura, Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DihydroergotamineDrug
Also called Dihydroergotamine Mesylate
Dihydroergotamine intranasal powder
DihydroergotamineDrug
Also called Dihydroergotamine Mesylate
Dihydroergotamine intramuscular injection
DihydroergotamineDrug
Also called Dihydroergotamine Mesylate
Dihydroergotamine intranasal spray
| Study group | Role | What they receive |
|---|---|---|
| STS101 5.2 mg | Experimental | STS101 (dihydroergotamine nasal powder), 5.2 mg Receives: Drug: Dihydroergotamine |
| STS101 7.0 mg | Experimental | STS101 (dihydroergotamine nasal powder), 7.0 mg Receives: Drug: Dihydroergotamine |
| STS101 8.6 mg | Experimental | STS101 (dihydroergotamine nasal powder), 8.6 mg Receives: Drug: Dihydroergotamine |
| DHE intramuscular injection | Active comparator | Dihydroergotamine mesylate Receives: Drug: Dihydroergotamine |
| DHE nasal spray | Active comparator | Dihydroergotamine mesylate Receives: Drug: Dihydroergotamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 .
Measured: Pre-dose through 48 hours Post-Dose
Secondary outcomes (2)
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
Measured: 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
Measured: Pre-dose through 48 hours Post-Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start5 Mar 2021
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satsuma Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Levy, MD, Principal investigator, Quotient Sciences Miami Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337254
- Sponsor's protocol ID
- STS101-006
- Status last verified
- Apr 2022
- First submitted
- 29 Mar 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38413540
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, 5-Period Crossover Study to Evaluate the PK, Bioavailability, Safety, and Tolerability of Single Doses of STS101, DHE IM Injection and DHE Nasal Spray in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05337254
- Acronym / sponsor ID
- STS101-006
- Conditions
- Migraine, Migraine With Aura, Migraine Without Aura
- Keywords
- dihydroergotamine, dihydroergotamine mesylate, migraine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Satsuma Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-center, single-dose, open-label, 5-period crossover (in each part), pharmacokinetic and safety study.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| STS101 5.2 mg | Experimental | Drug: DihydroergotamineSTS101 (dihydroergotamine nasal powder), 5.2 mg |
| STS101 7.0 mg | Experimental | Drug: DihydroergotamineSTS101 (dihydroergotamine nasal powder), 7.0 mg |
| STS101 8.6 mg | Experimental | Drug: DihydroergotamineSTS101 (dihydroergotamine nasal powder), 8.6 mg |
| DHE intramuscular injection | Active comparator | Drug: DihydroergotamineDihydroergotamine mesylate |
| DHE nasal spray | Active comparator | Drug: DihydroergotamineDihydroergotamine mesylate |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 to 50 years of age at the time of enrollment.
- Signed the informed consent document.
- Subject judged to be healthy by a qualified physician
Key exclusion criteria (3 listed)
- Abnormal physical findings of clinical significance at the screening examination
- Significant abnormal laboratory values at the Screening Visit.
- Clinically significant symptoms or conditions that may have placed the subject at an unacceptable risk as a participant in the trial, or that may have interfered with the absorption, distribution, metabolism or excretion of the IMP.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DihydroergotamineAlso: Dihydroergotamine MesylateDihydroergotamine intranasal powder | Drug | STS101 5.2 mg, STS101 7.0 mg, STS101 8.6 mg |
| DihydroergotamineAlso: Dihydroergotamine MesylateDihydroergotamine intramuscular injection | Drug | DHE intramuscular injection |
| DihydroergotamineAlso: Dihydroergotamine MesylateDihydroergotamine intranasal spray | Drug | DHE nasal spray |
Primary outcome
DHE Relative Bioavailability
Time frame: Pre-dose through 48 hours Post-Dose
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.
DHE Comparative Bioavailability
Time frame: Pre-dose through 48 hours Post-Dose
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 .
2 secondary outcomes
Serious Adverse Events
Time frame: Pre-dose through 48 hours Post-Dose
Treatment-Related Adverse Events
Time frame: Pre-dose through 48 hours Post-Dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Derived from this study: PubMed 38413540Lipton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Levy, MD principal investigator
Quotient Sciences Miami Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dihydroergotamine in people with Migraine and Migraine With Aura, run by Satsuma Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DHE Relative Bioavailability (time frame: Pre-dose through 48 hours Post-Dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05337254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.