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MigrainePhase 3EMERGENCT03901482

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate 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 117 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 STS101-002 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
1,201 participants
Where
117 sitesUnited States
Study dates
24 Jun 2019to 13 Aug 2020
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

117 sites in 1 country.

117 sites in 1 country

United States117 sites

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87109

  • Albuquerque Neuroscience

    Albuquerque, New Mexico, 87109

  • Wellness Clinical Research

    Allen, Texas, 75013

  • Michigan Headache and Neurological Institute

    Ann Arbor, Michigan, 48104

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

  • Delricht - Baton Rouge

    Baton Rouge, Louisiana, 70816

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Accel Clinical - Birmingham

    Birmingham, Alabama, 35216

  • Alabama Clinical Therapeutics

    Birmingham, Alabama, 35235

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • SPRI Clinical Trials

    Brooklyn, New York, 11235

  • Minneapolis Clinic of Neurology

    Burnsville, Minnesota, 55337

  • The Research Center of Southern California

    Carlsbad, California, 92011

  • Med Center Medical Clinic

    Carmichael, California, 95608

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • WR-ClinSearch

    Chattanooga, Tennessee, 37421

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

  • Rapid Medical Research Inc.

    Cleveland, Ohio, 44122

  • Aventiv Research

    Columbus, Ohio, 43213

  • Future Search Trials

    Dallas, Texas, 75231

  • HRMD Research

    Dallas, Texas, 75240

  • Neurology Diagnosis

    Dayton, Ohio, 45459

  • Neuro Studios

    Decatur, Georgia, 30033

  • Accel Clinical - DeLand

    DeLand, Florida, 32720

  • PMG Research of DuPage Medical Group

    Downers Grove, Illinois, 60515

  • Hartford Headache Center

    East Hartford, Connecticut, 06118

  • WR-PRI

    Encino, California, 91316

  • Lillestol Research

    Fargo, North Dakota, 58104

  • Healthcare Research Network II, LLC

    Flossmoor, Illinois, 60422

  • Gulf Coast Clinical Research

    Fort Myers, Florida, 33912

  • Headache Wellness Center - Greensboro

    Greensboro, North Carolina, 27405

  • PharmQuest

    Greensboro, North Carolina, 27408

  • MD Clinical

    Hallandale, Florida, 33009

  • CMR of Greater New Haven

    Hamden, Connecticut, 06517

  • Healthcare Research Network II, LLC

    Hazelwood, Missouri, 63042

  • AGA Clinical Trials

    Hialeah, Florida, 33012

  • Galiz Research- Hialeah

    Hialeah, Florida, 33016

  • Research Centers of America

    Hollywood, Florida, 33024

  • Texas Center for Drug Development

    Houston, Texas, 77081

  • Marvel Clinical Research

    Huntington Beach, California, 92647

  • CNS Healthcare

    Jacksonville, Florida, 32256

  • eStudySite

    La Mesa, California, 91942

  • Multispecialty Research Associates

    Lake City, Florida, 32055

  • Altea Research

    Las Vegas, Nevada, 89102

  • Wake Research-Clinical Research Center of Nevada

    Las Vegas, Nevada, 89118

  • Clinical Research of South Nevada

    Las Vegas, Nevada, 89121

  • Dartmouth-Hitchcock Clinical Trials Office

    Lebanon, New Hampshire, 03756

  • Collaborative Neuroscience

    Long Beach, California, 90806

  • WP-PRI

    Los Alamitos, California, 90720

  • Downtown LA Research

    Los Angeles, California, 90017

  • Cal Neuro Research Group

    Los Angeles, California, 90024

  • ClinCloud

    Maitland, Florida, 32751

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • CNS Healthcare

    Memphis, Tennessee, 38119

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • SMS Clinical Research

    Mesquite, Texas, 75149

  • Premier Clinical Reserch Institute, INC

    Miami, Florida, 33122

  • QPS MRA

    Miami, Florida, 33143

  • Applemed Research Group

    Miami, Florida, 33155

  • Biotech Pharmaceuticals Group

    Miami, Florida, 33155

  • Montana Medical Research

    Missoula, Montana, 59808

  • Clinical Research Associates

    Nashville, Tennessee, 37203

  • Nashville Neuroscience Group

    Nashville, Tennessee, 37203

  • BTC of New Bedford

    New Bedford, Massachusetts, 02740

  • Delricht - NewOrleans

    New Orleans, Louisiana, 70124

  • Manhattan Behavioral Medicine

    New York, New York, 10036

  • WR-PRI

    Newport Beach, California, 92660

  • Behavioral Clinical Research

    North Miami, Florida, 33161

  • Alliance Sites

    Oakland, California, 94607

  • Sensible Health

    Ocoee, Florida, 34761

  • Delynn Institute

    Oklahoma City, Oklahoma, 73112

  • Quality Clinical Research

    Omaha, Nebraska, 68114

  • Accel - Orange City

    Orange City, Florida, 32763

  • Aspen Clinical Research

    Orem, Utah, 84058

  • CNS Health Care - Orlando

    Orlando, Florida, 32801

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida, 32174

  • Stanford Neuroscience Health Center

    Palo Alto, California, 94304

  • National Research Institute

    Panorama City, California, 91402

  • Thomas Jefferson University/Jefferson Headache Center

    Philadelphia, Pennsylvania, 19107

  • Alea Research

    Phoenix, Arizona, 85012

  • Elite Clinical Studies

    Phoenix, Arizona, 85018

  • Arizona Research Center

    Phoenix, Arizona, 85053

  • Empire Clinical Reserch

    Pomona, California, 91767

  • Phoenix Medical Reserch

    Prairie Village, Kansas, 66208

  • M3-Wake Research

    Raleigh, North Carolina, 27612

  • Artemis Institute for Clinical Research- Riverside

    Riverside, California, 92503

  • Rochester Clinical Research

    Rochester, New York, 14609

  • CNS Research Inc - Rhode Island

    Rumford, Rhode Island, 02916

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107

  • Highland Clinical Research

    Salt Lake City, Utah, 84124

  • Artemis Institute of Clinical Research - San Diego

    San Diego, California, 92103

  • Pacific Research Network

    San Diego, California, 92103

  • WR-MCCR

    San Diego, California, 92108

  • Optimus Medical Group

    San Francisco, California, 94102

  • Artemis Institute for Clinical Research- San Marcos

    San Marcos, California, 92103

  • Neurological Research Institute

    Santa Monica, California, 90404

  • Schuster Medical Research Institute

    Sherman Oaks, California, 91403

  • Southern California Research

    Simi Valley, California, 93065

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Clinvest Research

    Springfield, Missouri, 65810

  • New England Institute for Neurology and Headache

    Stamford, Connecticut, 06905

  • Infinity Clinical Research, LLC

    Sunrise, Florida, 33351

  • Precision Clinical Research

    Sunrise, Florida, 33351

  • Montefiori Medical Center

    The Bronx, New York, 10461

  • DM Clinical Research

    Tomball, Texas, 77375

  • Tucson Neuroscience Research

    Tucson, Arizona, 85710

  • Delricht Research

    Tulsa, Oklahoma, 74133

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • Chase Medical Research

    Waterbury, Connecticut, 06708

  • Medvadis Research Group

    Watertown, Massachusetts, 02472

  • ClinPoint Trials

    Waxahachie, Texas, 75165

  • Upstate Clinical Research Associates

    Williamsville, New York, 14221

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

  • Clinical Research CF

    Winter Haven, Florida, 33880

  • Conquest Research

    Winter Park, Florida, 32789

  • Michigan Pain Consultants

    Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: EMERGE: 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

Study STS101-002 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

The EMERGE trial 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, Placebos
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.

  • PlacebosDrug

    Also called STS101 Placebo

    Placebo for STS101

Study groups in NCT03901482
Study groupRoleWhat they receive
STS101 Low DoseExperimentalSTS101 (dihydroergotamine nasal powder), low dose
Receives: Drug: Dihydroergotamine
STS101 High DoseExperimentalSTS101 (dihydroergotamine nasal powder), high dose
Receives: Drug: Dihydroergotamine
STS101 PlaceboPlacebo comparatorSTS101 Placebo
Receives: Drug: Placebos

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 posted3 Apr 2019
  2. Study start24 Jun 2019
  3. Primary completion31 Jul 2020
  4. Study completion13 Aug 2020

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
1,201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03901482
Sponsor's protocol ID
STS101-002
Acronym
EMERGE
Status last verified
Jun 2023
First submitted
2 Apr 2019
Last updated
29 Jun 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 117 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 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 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. Some participants in this study may receive a placebo. 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 29 Jun 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 NCT03901482.

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 29 Jun 2023.

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