MigrainePhase 3ASCENDNCT04406649
A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine
A Phase 3 study testing Dihydroergotamine in people with Migraine and Migraine With Aura, run by Satsuma Pharmaceuticals, Inc. at 44 sites in United States.
Trial summary
Study STS101-003 is a multi-center, multiple dose (PRN), open-label, 12-month study to evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine, Migraine With Aura, Migraine Without Aura
- What is being tested?
- Dihydroergotamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 482 participants
- Where
- 44 sitesUnited States
- Study dates
- 14 Sep 2020to 16 Jan 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, 18-65 years of age at the time of Screening Visit
- Subject has at least 1-year history of migraines (with or without aura), according to the
- International Classification of Headache Disorder, 3rd Edition (ICHD3)
Who cannot join
- Pregnant or breast-feeding women
- Women of child-bearing potential not using or not willing to use highly effective contraception.
- Diagnosis of headache conditions other than migraine with or without aura, including diagnosis of basilar or hemiplegic migraines or cluster headache.
- History of coronary artery disease, coronary artery vasospasm (including Printz-metals' angina), clinically significant arrhythmia or, peripheral vascular disease, ischemic disease (e.g. Raynaud's syndrome, ischemic bowel syndrome, angina pectoris, myocardial infarction, or documented silent ischemia); percutaneous coronary intervention, or cardiac surgery.
- History of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage.
- Diagnosis of major depression with current symptoms, psychosis, alcohol abuse or dependence, drug abuse or dependence, major psychiatric conditions (e.g. schizophrenia, psychosis or Bipolar disorder), dementia. Other significant neurological or psychiatric disorders (including other pain syndromes or risk of suicide) that in the opinion of the investigator might interfere with study participation and assessments or subject safety.
- Any clinically significant symptoms or conditions, including but not limited to central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such conditions that, in the opinion of the investigator might interfere with study assessments or safety of participant.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102
FutureSearch Trials of Neurology
Austin, Texas, 78731
Hassman Research Institute
Berlin, New Jersey, 08009
SPRI Clinical Research
Brooklyn, New York, 11235
Charlottesville Medical Research
Charlottesville, Virginia, 22911
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Rapid Medical Research
Cleveland, Ohio, 44122
Neurology Diagnosis
Dayton, Ohio, 45459
Hillcrest Medical Research
DeLand, Florida, 32720
WR-PRI
Encino, California, 91316
PharmQuest
Greensboro, North Carolina, 27408
MD Clinical
Hallandale, Florida, 33009
Healthcare Research Network
Hazelwood, Missouri, 63042
Multi-Specialty Research Associates
Lake City, Florida, 32055
Wake Research - Clinical Research Center of Nevada
Las Vegas, Nevada, 89118
Dartmouth-Hitchcock Neurology Headache Clinic
Lebanon, New Hampshire, 03766
Collaborative Neuroscience
Long Beach, California, 90806
WR-PRI
Los Alamitos, California, 90720
Downtown LA Research
Los Angeles, California, 90017
Clinical Research Institute
Los Angeles, California, 90048
ClinCloud
Maitland, Florida, 32751
Georgetown University Hospital, Department of Neurology
McLean, Virginia, 22101
CNS Healthcare - Memphis
Memphis, Tennessee, 38119
Advanced Clinical Research
Meridian, Idaho, 83642
Biotech Pharmaceuticals
Miami, Florida, 33155
Behavioral Clinical Research
Miami Lakes, Florida, 33061
Montana Medical Research
Missoula, Montana, 59808
WR-PRI
Newport Beach, California, 92660
CNS Health Care - Orlando
Orlando, Florida, 32801
Complete Health Research
Ormond Beach, Florida, 32174
Thomas Jefferson University/Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
Delricht Research
Prairieville, Louisiana, 70769
Clinvest Research
Springfield, Missouri, 65810
Infinity Clinical Research
Sunrise, Florida, 33351
Santos Research Center, Corp
Tampa, Florida, 33615
Montefiore Medical Center
The Bronx, New York, 10461
DM Clinical Research
Tomball, Texas, 77375
Delricht Research
Tulsa, Oklahoma, 74133
Medvadis Research at Boston PainCare Center
Waltham, Massachusetts, 02451
Omega Medical Research
Warwick, Rhode Island, 02886
Integrated Clinical Trial Services, Inc
West Des Moines, Iowa, 50265
Palm Beach Research Center
West Palm Beach, Florida, 33409
PMG Research of Wilmington
Wilmington, North Carolina, 28401
Clinical Research CF
Winter Haven, Florida, 33880
About this study
Official title: An Open-Label, 12-Month Study to Evaluate the Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine
Study STS101-003 is a multi-center, multiple dose (PRN), open-label, 12-month study to evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine.
Read the detailed description
The ASCEND trial is a multi-center, multiple dose (PRN), open-label, 12-month study to evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine.
- 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 is a semi-synthetic derivative of ergotamine tartrate.
| Study group | Role | What they receive |
|---|---|---|
| STS101 | Experimental | STS101 (dihydroergotamine nasal powder) Receives: Drug: Dihydroergotamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Attacks With Sustained Freedom From Headache Pain 2-48 Hours (Modified Intent to Treat Population)
The subject's rating was documented on a four-point scale from no pain (= 0), mild pain (= 1), moderate pain (= 2) to severe pain (= 3). Pain freedom means the pain went from moderate (2) or severe (3) to no pain (0).
Measured: At Month 12 of Study Medication Dosing
Percentage of Participants With Attacks With Sustained Freedom From Most Bothersome Symptom 2-48 Hours (Modified Intent to Treat Population)
Subjects were prompted to document the presence of 3 symptoms (photophobia, phonophobia, and nausea) immediately before study drug administration and during the treated migraine attack.
Measured: At Month 12 of Study Drug Administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start14 Sep 2020
- Primary completion16 Jan 2023
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satsuma Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Detlef Albrecht, MD, Study chair, Satsuma Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406649
- Sponsor's protocol ID
- STS101-003
- Acronym
- ASCEND
- Status last verified
- Jun 2023
- First submitted
- 20 May 2020
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ailani J, Charleston L 4th, Strom S, Albrecht D, Cowan R. Study participant impression of use and satisfaction with STS101 (dihydroergotamine nasal powder): Results from the open-label ASCEND acute migraine study. Headache. 2026 Mar;66(3):688-696. doi: 10.1111/head.15086. Epub 2025 Nov 4.
PubMed 41186275Tepper SJ, Albrecht D, Ailani J, Kirby L, Strom S, Rapoport AM. Long-Term (12-Month) Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine: Data from the Phase 3 Open-Label ASCEND Study. CNS Drugs. 2024 Dec;38(12):1017-1027. doi: 10.1007/s40263-024-01118-8. Epub 2024 Oct 7.
PubMed 39373843
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, 12-Month Study to Evaluate the Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine
- ClinicalTrials.gov ID
- NCT04406649
- Acronym / sponsor ID
- ASCEND / STS101-003
- Conditions
- Migraine, Migraine With Aura, Migraine Without Aura
- Keywords
- dihydroergotamine, dihydroergotamine mesylate, migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- Satsuma Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Posted 3 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study STS101-003 is a multi-center, multiple dose (PRN), open-label, 12-month study to evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine.
Detailed description
The ASCEND trial is a multi-center, multiple dose (PRN), open-label, 12-month study to evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STS101 | Experimental | Drug: DihydroergotamineSTS101 (dihydroergotamine nasal powder) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females, 18-65 years of age at the time of Screening Visit
- Subject has at least 1-year history of migraines (with or without aura), according to the
- International Classification of Headache Disorder, 3rd Edition (ICHD3)
Key exclusion criteria (7 listed)
- Pregnant or breast-feeding women
- Women of child-bearing potential not using or not willing to use highly effective contraception.
- Diagnosis of headache conditions other than migraine with or without aura, including diagnosis of basilar or hemiplegic migraines or cluster headache.
- History of coronary artery disease, coronary artery vasospasm (including Printz-metals' angina), clinically significant arrhythmia or, peripheral vascular disease, ischemic disease (e.g. Raynaud's syndrome, ischemic bowel syndrome, angina pectoris, myocardial infarction, or documented silent ischemia); percutaneous coronary intervention, or cardiac surgery.
- History of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage.
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 | STS101 |
Primary outcome
Percentage of Participants With Attacks With Sustained Freedom From Headache Pain 2-48 Hours (Modified Intent to Treat Population)
Time frame: At Month 12 of Study Medication Dosing
The subject's rating was documented on a four-point scale from no pain (= 0), mild pain (= 1), moderate pain (= 2) to severe pain (= 3). Pain freedom means the pain went from moderate (2) or severe (3) to no pain (0).
Percentage of Participants With Attacks With Sustained Freedom From Most Bothersome Symptom 2-48 Hours (Modified Intent to Treat Population)
Time frame: At Month 12 of Study Drug Administration
Subjects were prompted to document the presence of 3 symptoms (photophobia, phonophobia, and nausea) immediately before study drug administration and during the treated migraine attack.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41186275Ailani J, Charleston L 4th, Strom S, Albrecht D, Cowan R. Study participant impression of use and satisfaction with STS101 (dihydroergotamine nasal powder): Results from the open-label ASCEND acute migraine study. Headache. 2026 Mar;66(3):688-696. doi: 10.1111/head.15086. Epub 2025 Nov 4.
- Derived from this study: PubMed 39373843Tepper SJ, Albrecht D, Ailani J, Kirby L, Strom S, Rapoport AM. Long-Term (12-Month) Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine: Data from the Phase 3 Open-Label ASCEND Study. CNS Drugs. 2024 Dec;38(12):1017-1027. doi: 10.1007/s40263-024-01118-8. Epub 2024 Oct 7.
- 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.
Detlef Albrecht, MD study chair
Satsuma Pharmaceuticals, Inc.
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dihydroergotamine in people with Migraine and Migraine With Aura, run by Satsuma Pharmaceuticals, Inc. at 44 sites 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 7 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Attacks With Sustained Freedom From Headache Pain 2-48 Hours (Modified Intent to Treat Population) (time frame: At Month 12 of Study Medication Dosing). 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 NCT04406649, which also lists 2 linked publications.
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 3 Jul 2023.