A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine Clinical Trial Results and Information

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

ClinicalTrials.gov processed this data on June 9, 2023. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED - HAS RESULTS
(See Contacts and Locations)
Verified June 2023 by Satsuma Pharmaceuticals, Inc.

Sponsor

Satsuma Pharmaceuticals, Inc.

Information Provided by (Responsible Party)

Satsuma Pharmaceuticals, Inc.

Clinicaltrials.gov Identifier

NCT03901482
Other Study ID Numbers: STS101-002
First Submitted: April 2, 2019
First Posted: April 3, 2019
Results First Posted: June 29, 2023
Last Update Posted: June 29, 2023
Last Verified: June 2023
History of Changes

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Study 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).

Condition or Disease	Intervention/Treatment
Migraine Migraine With Aura Migraine Without Aura	Drug: Dihydroergotamine Drug: Placebos

Study Design

Study Type	Interventional
Actual Enrollment	1201 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Triple
Primary Purpose	Treatment
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 Start Date	June 24, 2019
Actual Primary Completion Date	July 31, 2020
Actual Study Completion Date	August 13, 2020

Groups and Cohorts

Group/ Cohort	Intervention/ Treatment
STS101 Low Dose STS101 (dihydroergotamine nasal powder), low dose	Drug: Dihydroergotamine Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
STS101 High Dose STS101 (dihydroergotamine nasal powder), high dose	Drug: Dihydroergotamine Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
STS101 Placebo STS101 Placebo	Drug: Placebos

Outcome Measures

Primary Outcome Measures

Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose [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).
Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose [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.

Secondary Outcome Measures

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

Eligibility Criteria

Ages Eligible for Study	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
Inclusion Criteria	a: 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)
Exclusion Criteria	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.

Contacts and Locations

Sponsors and Collaborators	Satsuma Pharmaceuticals, Inc.
Locations	Accel Clinical - Birmingham \| Birmingham, Alabama, United States, 35216 Alabama Clinical Therapeutics \| Birmingham, Alabama, United States, 35235 Alea Research \| Phoenix, Arizona, United States, 85012 Elite Clinical Studies \| Phoenix, Arizona, United States, 85018 Arizona Research Center \| Phoenix, Arizona, United States, 85053 Tucson Neuroscience Research \| Tucson, Arizona, United States, 85710 The Research Center of Southern California \| Carlsbad, California, United States, 92011 Med Center Medical Clinic \| Carmichael, California, United States, 95608 WR-PRI \| Encino, California, United States, 91316 Marvel Clinical Research \| Huntington Beach, California, United States, 92647 eStudySite \| La Mesa, California, United States, 91942 Collaborative Neuroscience \| Long Beach, California, United States, 90806 WP-PRI \| Los Alamitos, California, United States, 90720 Downtown LA Research \| Los Angeles, California, United States, 90017 Cal Neuro Research Group \| Los Angeles, California, United States, 90024 WR-PRI \| Newport Beach, California, United States, 92660 Alliance Sites \| Oakland, California, United States, 94607 Stanford Neuroscience Health Center \| Palo Alto, California, United States, 94304 National Research Institute \| Panorama City, California, United States, 91402 Empire Clinical Reserch \| Pomona, California, United States, 91767 Artemis Institute for Clinical Research- Riverside \| Riverside, California, United States, 92503 Artemis Institute of Clinical Research - San Diego \| San Diego, California, United States, 92103 Pacific Research Network \| San Diego, California, United States, 92103 WR-MCCR \| San Diego, California, United States, 92108 Optimus Medical Group \| San Francisco, California, United States, 94102 Artemis Institute for Clinical Research- San Marcos \| San Marcos, California, United States, 92103 Neurological Research Institute \| Santa Monica, California, United States, 90404 Schuster Medical Research Institute \| Sherman Oaks, California, United States, 91403 Southern California Research \| Simi Valley, California, United States, 93065 Encompass Clinical Research \| Spring Valley, California, United States, 91978 Hartford Headache Center \| East Hartford, Connecticut, United States, 06118 CMR of Greater New Haven \| Hamden, Connecticut, United States, 06517 New England Institute for Neurology and Headache \| Stamford, Connecticut, United States, 06905 Chase Medical Research \| Waterbury, Connecticut, United States, 06708 Accel Clinical - DeLand \| DeLand, Florida, United States, 32720 Gulf Coast Clinical Research \| Fort Myers, Florida, United States, 33912 MD Clinical \| Hallandale Beach, Florida, United States, 33009 AGA Clinical Trials \| Hialeah, Florida, United States, 33012 Galiz Research- Hialeah \| Hialeah, Florida, United States, 33016 Research Centers of America \| Hollywood, Florida, United States, 33024 CNS Healthcare \| Jacksonville, Florida, United States, 32256 Multispecialty Research Associates \| Lake City, Florida, United States, 32055 ClinCloud \| Maitland, Florida, United States, 32751 Premier Clinical Reserch Institute, INC \| Miami, Florida, United States, 33122 QPS MRA \| Miami, Florida, United States, 33143 Applemed Research Group \| Miami, Florida, United States, 33155 Biotech Pharmaceuticals Group \| Miami, Florida, United States, 33155 Behavioral Clinical Research \| North Miami, Florida, United States, 33161 Sensible Health \| Ocoee, Florida, United States, 34761 Accel - Orange City \| Orange City, Florida, United States, 32763 CNS Health Care - Orlando \| Orlando, Florida, United States, 32801 Neurology Associates of Ormond Beach \| Ormond Beach, Florida, United States, 32174 Infinity Clinical Research, LLC \| Sunrise, Florida, United States, 33351 Precision Clinical Research \| Sunrise, Florida, United States, 33351 Clinical Research CF \| Winter Haven, Florida, United States, 33880 Conquest Research \| Winter Park, Florida, United States, 32789 Neuro Studios \| Decatur, Georgia, United States, 30033 Advanced Clinical Research \| Meridian, Idaho, United States, 83642 PMG Research of DuPage Medical Group \| Downers Grove, Illinois, United States, 60515 Healthcare Research Network II, LLC \| Flossmoor, Illinois, United States, 60422 Phoenix Medical Reserch \| Prairie Village, Kansas, United States, 66208 Delricht - Baton Rouge \| Baton Rouge, Louisiana, United States, 70816 Tandem Clinical Research \| Marrero, Louisiana, United States, 70072 Delricht - NewOrleans \| New Orleans, Louisiana, United States, 70124 Boston Clinical Trials \| Boston, Massachusetts, United States, 02131 BTC of New Bedford \| New Bedford, Massachusetts, United States, 02740 Medvadis Research Group \| Watertown, Massachusetts, United States, 02472 Michigan Headache and Neurological Institute \| Ann Arbor, Michigan, United States, 48104 Michigan Pain Consultants \| Wyoming, Michigan, United States, 49519 Minneapolis Clinic of Neurology \| Burnsville, Minnesota, United States, 55337 Healthcare Research Network II, LLC \| Hazelwood, Missouri, United States, 63042 StudyMetrix Research \| Saint Peters, Missouri, United States, 63303 Clinvest Research \| Springfield, Missouri, United States, 65810 Montana Medical Research \| Missoula, Montana, United States, 59808 Quality Clinical Research \| Omaha, Nebraska, United States, 68114 Altea Research \| Las Vegas, Nevada, United States, 89102 Wake Research-Clinical Research Center of Nevada \| Las Vegas, Nevada, United States, 89118 Clinical Research of South Nevada \| Las Vegas, Nevada, United States, 89121 Dartmouth-Hitchcock Clinical Trials Office \| Lebanon, New Hampshire, United States, 03756 Hassman Research Institute \| Berlin, New Jersey, United States, 08009 Albuquerque Clinical Trials \| Albuquerque, New Mexico, United States, 87109 Albuquerque Neuroscience \| Albuquerque, New Mexico, United States, 87109 Montefiori Medical Center \| Bronx, New York, United States, 10461 SPRI Clinical Trials \| Brooklyn, New York, United States, 11235 Manhattan Behavioral Medicine \| New York, New York, United States, 10036 Rochester Clinical Research \| Rochester, New York, United States, 14609 Upstate Clinical Research Associates \| Williamsville, New York, United States, 14221 Headache Wellness Center - Greensboro \| Greensboro, North Carolina, United States, 27405 PharmQuest \| Greensboro, North Carolina, United States, 27408 M3-Wake Research \| Raleigh, North Carolina, United States, 27612 PMG Research of Wilmington \| Wilmington, North Carolina, United States, 28401 Lillestol Research \| Fargo, North Dakota, United States, 58104 CTI Clinical Research Center \| Cincinnati, Ohio, United States, 45212 Rapid Medical Research Inc. \| Cleveland, Ohio, United States, 44122 Aventiv Research \| Columbus, Ohio, United States, 43213 Neurology Diagnosis \| Dayton, Ohio, United States, 45459 Delynn Institute \| Oklahoma City, Oklahoma, United States, 73112 Delricht Research \| Tulsa, Oklahoma, United States, 74133 Thomas Jefferson University/Jefferson Headache Center \| Philadelphia, Pennsylvania, United States, 19107 CNS Research Inc - Rhode Island \| Rumford, Rhode Island, United States, 02916 Omega Medical Research \| Warwick, Rhode Island, United States, 02886 WR-ClinSearch \| Chattanooga, Tennessee, United States, 37421 CNS Healthcare \| Memphis, Tennessee, United States, 38119 Clinical Research Associates \| Nashville, Tennessee, United States, 37203 Nashville Neuroscience Group \| Nashville, Tennessee, United States, 37203 Wellness Clinical Research \| Allen, Texas, United States, 75013 FutureSearch Trials of Neurology \| Austin, Texas, United States, 78731 Future Search Trials \| Dallas, Texas, United States, 75231 HRMD Research \| Dallas, Texas, United States, 75240 Texas Center for Drug Development \| Houston, Texas, United States, 77081 SMS Clinical Research \| Mesquite, Texas, United States, 75149 DM Clinical Research \| Tomball, Texas, United States, 77375 ClinPoint Trials \| Waxahachie, Texas, United States, 75165 Aspen Clinical Research \| Orem, Utah, United States, 84058 Wasatch Clinical Research \| Salt Lake City, Utah, United States, 84107 Highland Clinical Research \| Salt Lake City, Utah, United States, 84124 Charlottesville Medical Research \| Charlottesville, Virginia, United States, 22911
Investigators

Study Documents (Full Text)

Documents Provided by Satsuma Pharmaceuticals, Inc.: Study Protocol and Statistical Analysis Plan April 9, 2019

More Information

Additional Relevant MeSH Terms

Migraine Disorders
Migraine without Aura
Migraine with Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases