A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified May 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 1, 2019
First Posted
April 2, 2019
Results First Posted
April 18, 2023
Last Update Posted
June 28, 2023
Last Verified
May 2023

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

History of Changes

Study Details

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 DiseaseIntervention/Treatment
MigraineMigraine With AuraMigraine Without Aura
Drug: DihydroergotamineDrug: DihydroergotamineDrug: Placebos

Study Design

Study TypeInterventional
Actual Enrollment1201 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleEMERGE: 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 DateJune 23, 2019
Actual Primary Completion DateJuly 30, 2020
Actual Study Completion DateAugust 12, 2020

Groups and Cohorts

Group/CohortIntervention/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
Placebo for STS101

Outcome Measures

Primary Outcome Measures
  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).
  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.
Secondary Outcome Measures
  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).

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
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 CollaboratorsSatsuma Pharmaceuticals, Inc.
Locations
Accel Clinical - Birmingham | Birmingham Alabama, United States, 35216Alabama Clinical Therapeutics | Birmingham Alabama, United States, 35235Alea Research | Phoenix Arizona, United States, 85012Elite Clinical Studies | Phoenix Arizona, United States, 85018Arizona Research Center | Phoenix Arizona, United States, 85053Tucson Neuroscience Research | Tucson Arizona, United States, 85710The Research Center of Southern California | Carlsbad California, United States, 92011Med Center Medical Clinic | Carmichael California, United States, 95608WR-PRI | Encino California, United States, 91316Marvel Clinical Research | Huntington Beach California, United States, 92647eStudySite | La Mesa California, United States, 91942Collaborative Neuroscience | Long Beach California, United States, 90806WP-PRI | Los Alamitos California, United States, 90720Downtown LA Research | Los Angeles California, United States, 90017Cal Neuro Research Group | Los Angeles California, United States, 90024WR-PRI | Newport Beach California, United States, 92660Alliance Sites | Oakland California, United States, 94607Stanford Neuroscience Health Center | Palo Alto California, United States, 94304National Research Institute | Panorama City California, United States, 91402Empire Clinical Reserch | Pomona California, United States, 91767Artemis Institute for Clinical Research- Riverside | Riverside California, United States, 92503Artemis Institute of Clinical Research - San Diego | San Diego California, United States, 92103Pacific Research Network | San Diego California, United States, 92103WR-MCCR | San Diego California, United States, 92108Optimus Medical Group | San Francisco California, United States, 94102Artemis Institute for Clinical Research- San Marcos | San Marcos California, United States, 92103Neurological Research Institute | Santa Monica California, United States, 90404Schuster Medical Research Institute | Sherman Oaks California, United States, 91403Southern California Research | Simi Valley California, United States, 93065Encompass Clinical Research | Spring Valley California, United States, 91978Hartford Headache Center | East Hartford Connecticut, United States, 06118CMR of Greater New Haven | Hamden Connecticut, United States, 06517New England Institute for Neurology and Headache | Stamford Connecticut, United States, 06905Chase Medical Research | Waterbury Connecticut, United States, 06708Accel Clinical - DeLand | DeLand Florida, United States, 32720Gulf Coast Clinical Research | Fort Myers Florida, United States, 33912MD Clinical | Hallandale Florida, United States, 33009AGA Clinical Trials | Hialeah Florida, United States, 33012Galiz Research- Hialeah | Hialeah Florida, United States, 33016Research Centers of America | Hollywood Florida, United States, 33024CNS Healthcare | Jacksonville Florida, United States, 32256Multispecialty Research Associates | Lake City Florida, United States, 32055ClinCloud | Maitland Florida, United States, 32751Premier Clinical Reserch Institute, INC | Miami Florida, United States, 33122QPS MRA | Miami Florida, United States, 33143Applemed Research Group | Miami Florida, United States, 33155Biotech Pharmaceuticals Group | Miami Florida, United States, 33155Behavioral Clinical Research | North Miami Florida, United States, 33161Sensible Health | Ocoee Florida, United States, 34761Accel - Orange City | Orange City Florida, United States, 32763CNS Health Care - Orlando | Orlando Florida, United States, 32801Neurology Associates of Ormond Beach | Ormond Beach Florida, United States, 32174Infinity Clinical Research, LLC | Sunrise Florida, United States, 33351Precision Clinical Research | Sunrise Florida, United States, 33351Clinical Research CF | Winter Haven Florida, United States, 33880Conquest Research | Winter Park Florida, United States, 32789Neuro Studios | Decatur Georgia, United States, 30033Advanced Clinical Research | Meridian Idaho, United States, 83642PMG Research of DuPage Medical Group | Downers Grove Illinois, United States, 60515Healthcare Research Network II, LLC | Flossmoor Illinois, United States, 60422Phoenix Medical Reserch | Prairie Village Kansas, United States, 66208Delricht - Baton Rouge | Baton Rouge Louisiana, United States, 70816Tandem Clinical Research | Marrero Louisiana, United States, 70072Delricht - NewOrleans | New Orleans Louisiana, United States, 70124Boston Clinical Trials | Boston Massachusetts, United States, 02131BTC of New Bedford | New Bedford Massachusetts, United States, 02740Medvadis Research Group | Watertown Massachusetts, United States, 02472Michigan Headache and Neurological Institute | Ann Arbor Michigan, United States, 48104Michigan Pain Consultants | Wyoming Michigan, United States, 49519Minneapolis Clinic of Neurology | Burnsville Minnesota, United States, 55337StudyMetrix Research | City of Saint Peters Missouri, United States, 63303Healthcare Research Network II, LLC | Hazelwood Missouri, United States, 63042Clinvest Research | Springfield Missouri, United States, 65810Montana Medical Research | Missoula Montana, United States, 59808Quality Clinical Research | Omaha Nebraska, United States, 68114Altea Research | Las Vegas Nevada, United States, 89102Wake Research-Clinical Research Center of Nevada | Las Vegas Nevada, United States, 89118Clinical Research of South Nevada | Las Vegas Nevada, United States, 89121Dartmouth-Hitchcock Clinical Trials Office | Lebanon New Hampshire, United States, 03756Hassman Research Institute | Berlin New Jersey, United States, 08009Albuquerque Clinical Trials | Albuquerque New Mexico, United States, 87109Albuquerque Neuroscience | Albuquerque New Mexico, United States, 87109SPRI Clinical Trials | Brooklyn New York, United States, 11235Manhattan Behavioral Medicine | New York New York, United States, 10036Rochester Clinical Research | Rochester New York, United States, 14609Montefiori Medical Center | The Bronx New York, United States, 10461Upstate Clinical Research Associates | Williamsville New York, United States, 14221Headache Wellness Center - Greensboro | Greensboro North Carolina, United States, 27405PharmQuest | Greensboro North Carolina, United States, 27408M3-Wake Research | Raleigh North Carolina, United States, 27612PMG Research of Wilmington | Wilmington North Carolina, United States, 28401Lillestol Research | Fargo North Dakota, United States, 58104CTI Clinical Research Center | Cincinnati Ohio, United States, 45212Rapid Medical Research Inc. | Cleveland Ohio, United States, 44122Aventiv Research | Columbus Ohio, United States, 43213Neurology Diagnosis | Dayton Ohio, United States, 45459Delynn Institute | Oklahoma City Oklahoma, United States, 73112Delricht Research | Tulsa Oklahoma, United States, 74133Thomas Jefferson University/Jefferson Headache Center | Philadelphia Pennsylvania, United States, 19107CNS Research Inc - Rhode Island | Rumford Rhode Island, United States, 02916Omega Medical Research | Warwick Rhode Island, United States, 02886WR-ClinSearch | Chattanooga Tennessee, United States, 37421CNS Healthcare | Memphis Tennessee, United States, 38119Clinical Research Associates | Nashville Tennessee, United States, 37203Nashville Neuroscience Group | Nashville Tennessee, United States, 37203Wellness Clinical Research | Allen Texas, United States, 75013FutureSearch Trials of Neurology | Austin Texas, United States, 78731Future Search Trials | Dallas Texas, United States, 75231HRMD Research | Dallas Texas, United States, 75240Texas Center for Drug Development | Houston Texas, United States, 77081SMS Clinical Research | Mesquite Texas, United States, 75149DM Clinical Research | Tomball Texas, United States, 77375ClinPoint Trials | Waxahachie Texas, United States, 75165Aspen Clinical Research | Orem Utah, United States, 84058Wasatch Clinical Research | Salt Lake City Utah, United States, 84107Highland Clinical Research | Salt Lake City Utah, United States, 84124Charlottesville Medical Research | Charlottesville Virginia, United States, 22911
Investigators
Study Chair: Detlef Albrecht, MD, Satsuma Pharmaceuticals, Inc.
Study Documents (Full Text)
Documents provided by Satsuma Pharmaceuticals, Inc.: Study Protocol and Statistical Analysis Plan  April 8, 2019