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MigrainePhase 3SUMMITNCT04940390

A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess 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 127 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Study STS101-007 is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of single doses 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
What is being tested?
Dihydroergotamine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,591 participants
Where
127 sitesUnited States
Study dates
30 Jun 2021to 26 Oct 2022
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

127 sites in 1 country.

127 sites in 1 country

United States127 sites

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102

  • PMG Research Inc

    Ames, Iowa, 50010

  • MHNI

    Ann Arbor, Michigan, 48104

  • Delricht

    Atlanta, Georgia, 30329

  • Future Search Trials of Neurology

    Austin, Texas, 78731

  • Premier Family Physicians

    Austin, Texas, 78735

  • Delricht Research

    Baton Rouge, Louisiana, 70817

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Neurology Offices of South Florida

    Boca Raton, Florida, 33428

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Alpine Clinical Research Center, Inc

    Boulder, Colorado, 80301

  • Internal Medicine and Pediatric Associates of Bristol, PC

    Bristol, Tennessee, 37620

  • Integrative Clinical Trials

    Brooklyn, New York, 11229

  • SPRI Clinical Trials, LLC

    Brooklyn, New York, 11235

  • Discoveresearch

    Bryan, Texas, 77802

  • Minneapolis Clinic of Neurology

    Burnsville, Minnesota, 55337

  • Hope Clinical Research

    Canoga Park, California, 91303

  • Crescent City Headache and Neurology

    Chalmette, Louisiana, 70043

  • MD First Research

    Chandler, Arizona, 85286

  • Clinedge LLC - Clinical Trials SSC

    Charleston, South Carolina, 29406

  • PMG Research of Charlotte

    Charlotte, North Carolina, 28209

  • Onsite Clinical

    Charlotte, North Carolina, 28277

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

  • Aventiv Research

    Columbus, Ohio, 43213

  • North Suffolk Neurology

    Commack, New York, 11725

  • Delricht

    Covington, Louisiana, 70433

  • Clinedge, LLC

    Cromwell, Connecticut, 06416

  • Future Search Trials of Dallas, LP

    Dallas, Texas, 75231

  • Cedar Health Research, LLC

    Dallas, Texas, 75251

  • I-Research Atlanta

    Decatur, Georgia, 30030

  • Aventiv Research, Inc

    Dublin, Ohio, 43016

  • OK Clinical Research

    Edmond, Oklahoma, 73034

  • Skyline Medical Center, PC CCT Research

    Elkhorn, Nebraska, 68022

  • Wr-Pri, Llc

    Encino, California, 91316

  • Medisphere Medical Research Center

    Evansville, Indiana, 47714

  • Cognitive Clinical Trials, LLC

    Fremont, Nebraska, 68025

  • Neuro-Pain Medical Center Ince

    Fresno, California, 93710

  • North Texas Institute of Neurology

    Frisco, Texas, 75034

  • Headache Wellness Center - Greensboro

    Greensboro, North Carolina, 27405

  • Pharmquest, LLC

    Greensboro, North Carolina, 27408

  • Tribe CR

    Greenville, South Carolina, 29607

  • Delricht

    Gulfport, Mississippi, 39503

  • Velocity Clinical Research, Hallendale Beach

    Hallandale, Florida, 33009

  • Drug Trials America

    Hartsdale, New York, 10530

  • Peters Medical Research

    High Point, North Carolina, 27262

  • Infinity Clinical Research, LLC

    Hollywood, Florida, 33024

  • Elite Research Network, LLC a Florida LLC

    Jacksonville, Florida, 32216

  • Clinical Neuroscience Solutions, Inc

    Jacksonville, Florida, 32256

  • Alpha Clinical Research Georgia

    Johns Creek, Georgia, 30022

  • Elite Research Network LLC a Florida LLC

    Jupiter, Florida, 33458

  • Alliance for Multispecialty Research

    Kansas City, Missouri, 64114

  • New Phase Research & Development

    Knoxville, Tennessee, 37909

  • Estudy Site - La Mesa

    La Mesa, California, 91942

  • Multi-Specialty Research Associates

    Lake City, Florida, 32055

  • Excel Clinical Research

    Las Vegas, Nevada, 89109

  • Wake Research-Clinical Research Center of Nevada LLC

    Las Vegas, Nevada, 89118

  • Epic Clinical Research

    Lewisville, Texas, 75057

  • Alliance For Multispecialty Research

    Lexington, Kentucky, 40509

  • Ocean State Clinical Research Partners

    Lincoln, Rhode Island, 02865

  • ERG Clinical

    Little Rock, Arkansas, 72211

  • Wr-Pri Llc

    Los Alamitos, California, 90720

  • Downtown LA Research Center

    Los Angeles, California, 90017

  • Clinical Research Institute

    Los Angeles, California, 90048

  • Louisville Metabolic & Atherosclerosis Research Center

    Louisville, Kentucky, 40213

  • DM Clinical Research

    Magnolia, Texas, 77355

  • Clinicloud

    Maitland, Florida, 32751

  • Central New York Clinical Research

    Manlius, New York, 13104

  • Clin-Edge, LLC

    Marietta, Georgia, 30060

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • Next Phase Research

    Miami, Florida, 33144

  • Applemed Research Group

    Miami, Florida, 33155

  • Biotech Pharmaceuticals Group LLC

    Miami, Florida, 33155

  • Novel Clinical Research Center LLC

    Miami, Florida, 33173

  • Floridian Research

    Miami, Florida, 33179

  • Montana Medical Research, Inc

    Missoula, Montana, 59808

  • Clinical Research Associates, Inc

    Nashville, Tennessee, 37203

  • BTC of New Bedford

    New Bedford, Massachusetts, 02740

  • Alliance for Multispecialty Research

    New Orleans, Louisiana, 70119

  • Delricht-New Orleans

    New Orleans, Louisiana, 70124

  • Wr-Pri Llc

    Newport Beach, California, 92660

  • Alliance For Multispecialty Research

    Norfolk, Virginia, 23502

  • Elite Research Network, LLC a Florida LLC

    Norman, Oklahoma, 73072

  • Coastal Carolina Research Center Inc

    North Charleston, South Carolina, 29405

  • Northeast Medical Research Associates

    North Dartmouth, Massachusetts, 02747

  • Clinedge LLC

    North Las Vegas, Nevada, 89030

  • Behavioral Clinical Research

    North Miami, Florida, 33161

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73134

  • Quality Clinical Research, Inc

    Omaha, Nebraska, 68114

  • Accel-Orange City

    Orange City, Florida, 32763

  • CNS Health Care Orlando

    Orlando, Florida, 32801

  • Complete Health Research

    Ormond Beach, Florida, 32174

  • Oveido Medical Research

    Oviedo, Florida, 32765

  • Elite Clinical Studies

    Phoenix, Arizona, 85018

  • Village Health Partners

    Plano, Texas, 75024

  • North Carolina Clinical Research

    Raleigh, North Carolina, 27607

  • PMG Research, Inc

    Raleigh, North Carolina, 27609

  • Sun Research

    San Antonio, Texas, 78215

  • Artemis Institute for Clinical Research - San Diego

    San Diego, California, 92103

  • WR-MCCR

    San Diego, California, 92108

  • Acclaim Clinical Research

    San Diego, California, 92120

  • National Research Institute, A Clinical Research Organization

    Santa Ana, California, 92704

  • I Research Savannah

    Savannah, Georgia, 31405

  • Seattle Womens

    Seattle, Washington, 98105

  • Hillcrest Clinical Research

    Simpsonville, South Carolina, 29681

  • Meridian Clinical Research

    Sioux City, Iowa, 51106

  • Plains Clinical Research

    South West Fargo, North Dakota, 58104

  • Santos Research Center

    Tampa, Florida, 33603

  • VICIS Clinical Research, Inc

    Tampa, Florida, 33615

  • Alliance For Multispecialty Research

    Tempe, Arizona, 85283

  • Cognitive Clinical Trials, LLC

    Tempe, Arizona, 85283

  • DM Clinical Research

    Tomball, Texas, 77375

  • Clinedge, LLC

    Tucson, Arizona, 85704

  • Delricht Research

    Tulsa, Oklahoma, 74133

  • Tidewater Integrated Medical Research

    Virginia Beach, Virginia, 23454

  • "Medvadis Research Corp, Llc @Boston Paincare Center "

    Waltham, Massachusetts, 02451

  • Velocity Clinical Research.- Providence

    Warwick, Rhode Island, 02886

  • CIS Research

    Wauconda, Illinois, 60084

  • Integrated Clinical Trial SVC

    West Des Moines, Iowa, 50265

  • Palm Beach Research

    West Palm Beach, Florida, 33409

  • Upstate Clinical Research Associates

    Williamsville, New York, 14221

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

  • PMG Research Inc

    Winston-Salem, North Carolina, 27103

  • Conquest Research, LLC

    Winter Park, Florida, 32789

  • Tekton Research

    Yukon, Oklahoma, 73099

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine

Study STS101-007 is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of single doses of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine.

Read the detailed description

Study STS101-007 is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study in subjects with acute migraine (ages 18 to 65 years).

Being tested
Dihydroergotamine, Placebo
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.

  • PlaceboDrug

    Also called STS101 Placebo

    Placebo for STS101

Study groups in NCT04940390
Study groupRoleWhat they receive
STS101ExperimentalSTS101 (dihydroergotamine nasal powder)
Receives: Drug: Dihydroergotamine
STS101 PlaceboExperimentalSTS101 Placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose

    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: 2 Hours Post-Dose

  2. Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose

    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: 2 Hours Post-Dose

Secondary outcomes (1)

  1. Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose

    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 relief means the pain went from moderate (2) or severe (3) to mild pain (1) or no pain (0).

    Measured: 2 Hours Post Dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2021
  2. Study start30 Jun 2021
  3. Primary completion13 Oct 2022
  4. Study completion26 Oct 2022

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,591 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04940390
Sponsor's protocol ID
STS101-007
Acronym
SUMMIT
Status last verified
Nov 2023
First submitted
17 Jun 2021
Last updated
27 Nov 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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 127 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 2 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 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 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 24 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 Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose (time frame: 2 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 NCT04940390.

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 27 Nov 2023.

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