Migraine With AuraPhase 1NCT03874832
A Phase I Study to Study 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 With Aura and Migraine Without Aura, run by Satsuma Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
Single-center, single-dose, open-label, 2-part, 3-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 With Aura, Migraine Without Aura, Migraine
- What is being tested?
- Dihydroergotamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2018to 7 Nov 2018
- 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, Crossover Study to Evaluate the PK, Bioavailability, Dose Proportionality, Safety, and Tolerability of Single Doses of STS101, DHE Mesylate IM Injection and DHE Mesylate Nasal Spray in Healthy Adult Subjects
Single-center, single-dose, open-label, 2-part, 3-period crossover (in each part), pharmacokinetic and safety study.
Read the detailed description
Phase 1, open-label, 2-part, single-dose pharmacokinetic and safety study of STS101 in healthy subjects. Part 1 was designed to identify a dose level of STS101 for administration in Part 2. Subjects in Part 1 received 3 ascending doses of STS101 in a 3-period crossover manner. During Part 2, subjects received the dose of STS101 selected from Part 1, 1.0 mg DHE mesylate IM injection, and 2 mg DHE mesylate nasal spray in a randomized, 3 period crossover manner.
- Conditions
- Migraine With Aura, Migraine Without Aura, Migraine
- Being tested
- Dihydroergotamine
- Keywords
- dihydroergotamine, dihydroergotamine mesylate, migraine
- Medical subject headings
- Migraine with Aura, Migraine without Aura, Migraine Disorders
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 is a semi-synthetic derivative of ergotamine tartrate.
| Study group | Role | What they receive |
|---|---|---|
| STS101 1.5 mg | Experimental | STS101 (dihydroergotamine nasal powder), 1.5 mg Receives: Drug: Dihydroergotamine |
| STS101 3.0 mg | Experimental | STS101 (dihydroergotamine nasal powder), 3.0 mg Receives: Drug: Dihydroergotamine |
| STS101 6.0 mg | Experimental | STS101 (dihydroergotamine nasal powder), 6.0 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.
STS101 Dose Selection - Part 1
To select a dose level of STS101 for further evaluation in Part 2
Measured: Pre-dose through 48 hours post-dose
DHE Relative Bioavailability - Part 2
To assess the relative bioavailability of dihydroergotamine following a single dose of STS101 at the dose level selected in Part 1 compared to a single dose of 1 mg DHE administered by intramuscular injection and 2 mg DHE administered as nasal spray
Measured: Pre-dose through 48 hours post-dose
Secondary outcomes (4)
DHE Area Under the Curve [AUC] - Part 1
To describe the pharmacokinetic profile based on the AUC of dihydroergotamine following single dose administration of 1.5 mg, 3.0 mg and 6.0 mg of STS101
Measured: Pre-dose through 48 hours post-dose
8'OH-DHE Area Under the Curve [AUC] - Part 1
To describe the pharmacokinetic profile based on the AUC of 8'hydroxydihydroergotamine (8'OH-DHE) following single dose administration of 1.5 mg, 3.0 mg and 6.0 mg of STS101
Measured: Pre-dose through 48 hours post-dose
Serious Adverse Events - Parts 1 & 2
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 - Parts 1 & 2
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 posted14 Mar 2019
- Study start11 Sep 2018
- Primary completion7 Nov 2018
- Study completion7 Nov 2018
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 Migraine With AuraStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satsuma Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey A Levy, MD, PhD, Principal investigator, Quotient Sciences Miami Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874832
- Sponsor's protocol ID
- STS101-001
- Status last verified
- Nov 2019
- First submitted
- 7 Mar 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Albrecht D, Iwashima M, Dillon D, Harris S, Levy J. 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. Headache. 2020 Apr;60(4):701-712. doi: 10.1111/head.13737. Epub 2020 Jan 27.
PubMed 31985049
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Crossover Study to Evaluate the PK, Bioavailability, Dose Proportionality, Safety, and Tolerability of Single Doses of STS101, DHE Mesylate IM Injection and DHE Mesylate Nasal Spray in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03874832
- Acronym / sponsor ID
- STS101-001
- Conditions
- Migraine With Aura, Migraine Without Aura, Migraine
- Keywords
- dihydroergotamine, dihydroergotamine mesylate, migraine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Satsuma Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 7 Nov 2018 (actual)
- Study completion
- 7 Nov 2018 (actual)
- First posted
- 14 Mar 2019 (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, 2-part, 3-period crossover (in each part), pharmacokinetic and safety study.
Detailed description
Phase 1, open-label, 2-part, single-dose pharmacokinetic and safety study of STS101 in healthy subjects. Part 1 was designed to identify a dose level of STS101 for administration in Part 2. Subjects in Part 1 received 3 ascending doses of STS101 in a 3-period crossover manner. During Part 2, subjects received the dose of STS101 selected from Part 1, 1.0 mg DHE mesylate IM injection, and 2 mg DHE mesylate nasal spray in a randomized, 3 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 1.5 mg | Experimental | Drug: DihydroergotamineSTS101 (dihydroergotamine nasal powder), 1.5 mg |
| STS101 3.0 mg | Experimental | Drug: DihydroergotamineSTS101 (dihydroergotamine nasal powder), 3.0 mg |
| STS101 6.0 mg | Experimental | Drug: DihydroergotamineSTS101 (dihydroergotamine nasal powder), 6.0 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 is a semi-synthetic derivative of ergotamine tartrate. | Drug | DHE intramuscular injection, DHE nasal spray, STS101 1.5 mg, STS101 3.0 mg, STS101 6.0 mg |
Primary outcome
STS101 Dose Selection - Part 1
Time frame: Pre-dose through 48 hours post-dose
To select a dose level of STS101 for further evaluation in Part 2
DHE Relative Bioavailability - Part 2
Time frame: Pre-dose through 48 hours post-dose
To assess the relative bioavailability of dihydroergotamine following a single dose of STS101 at the dose level selected in Part 1 compared to a single dose of 1 mg DHE administered by intramuscular injection and 2 mg DHE administered as nasal spray
4 secondary outcomes
DHE Area Under the Curve [AUC] - Part 1
Time frame: Pre-dose through 48 hours post-dose
8'OH-DHE Area Under the Curve [AUC] - Part 1
Time frame: Pre-dose through 48 hours post-dose
Serious Adverse Events - Parts 1 & 2
Time frame: Pre-dose through 48 hours post-dose
Treatment-Related Adverse Events - Parts 1 & 2
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 26 Nov 2019.
- Derived from this study: PubMed 31985049Albrecht D, Iwashima M, Dillon D, Harris S, Levy J. 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. Headache. 2020 Apr;60(4):701-712. doi: 10.1111/head.13737. Epub 2020 Jan 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 A Levy, MD, PhD 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 With Aura and Migraine Without 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 26 Nov 2019. 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?
STS101 Dose Selection - Part 1 (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 NCT03874832, 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 26 Nov 2019.