A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine
EMERGE
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
1 other identifier
interventional
1,201
1 country
117
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2019
Shorter than P25 for phase_3
117 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2019
CompletedFirst Posted
Study publicly available on registry
April 3, 2019
CompletedStudy Start
First participant enrolled
June 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2020
CompletedResults Posted
Study results publicly available
June 29, 2023
CompletedJune 29, 2023
June 1, 2023
1.1 years
April 2, 2019
April 19, 2023
June 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Hours Post-Dose
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.
2 Hours Post-Dose
Secondary Outcomes (1)
Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose
2 Hours Post Dose
Study Arms (3)
STS101 Low Dose
EXPERIMENTALSTS101 (dihydroergotamine nasal powder), low dose
STS101 High Dose
EXPERIMENTALSTS101 (dihydroergotamine nasal powder), high dose
STS101 Placebo
PLACEBO COMPARATORSTS101 Placebo
Interventions
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (117)
Accel Clinical - Birmingham
Birmingham, Alabama, 35216, United States
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235, United States
Alea Research
Phoenix, Arizona, 85012, United States
Elite Clinical Studies
Phoenix, Arizona, 85018, United States
Arizona Research Center
Phoenix, Arizona, 85053, United States
Tucson Neuroscience Research
Tucson, Arizona, 85710, United States
The Research Center of Southern California
Carlsbad, California, 92011, United States
Med Center Medical Clinic
Carmichael, California, 95608, United States
WR-PRI
Encino, California, 91316, United States
Marvel Clinical Research
Huntington Beach, California, 92647, United States
eStudySite
La Mesa, California, 91942, United States
Collaborative Neuroscience
Long Beach, California, 90806, United States
WP-PRI
Los Alamitos, California, 90720, United States
Downtown LA Research
Los Angeles, California, 90017, United States
Cal Neuro Research Group
Los Angeles, California, 90024, United States
WR-PRI
Newport Beach, California, 92660, United States
Alliance Sites
Oakland, California, 94607, United States
Stanford Neuroscience Health Center
Palo Alto, California, 94304, United States
National Research Institute
Panorama City, California, 91402, United States
Empire Clinical Reserch
Pomona, California, 91767, United States
Artemis Institute for Clinical Research- Riverside
Riverside, California, 92503, United States
Artemis Institute of Clinical Research - San Diego
San Diego, California, 92103, United States
Pacific Research Network
San Diego, California, 92103, United States
WR-MCCR
San Diego, California, 92108, United States
Optimus Medical Group
San Francisco, California, 94102, United States
Artemis Institute for Clinical Research- San Marcos
San Marcos, California, 92103, United States
Neurological Research Institute
Santa Monica, California, 90404, United States
Schuster Medical Research Institute
Sherman Oaks, California, 91403, United States
Southern California Research
Simi Valley, California, 93065, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Hartford Headache Center
East Hartford, Connecticut, 06118, United States
CMR of Greater New Haven
Hamden, Connecticut, 06517, United States
New England Institute for Neurology and Headache
Stamford, Connecticut, 06905, United States
Chase Medical Research
Waterbury, Connecticut, 06708, United States
Accel Clinical - DeLand
DeLand, Florida, 32720, United States
Gulf Coast Clinical Research
Fort Myers, Florida, 33912, United States
MD Clinical
Hallandale, Florida, 33009, United States
AGA Clinical Trials
Hialeah, Florida, 33012, United States
Galiz Research- Hialeah
Hialeah, Florida, 33016, United States
Research Centers of America
Hollywood, Florida, 33024, United States
CNS Healthcare
Jacksonville, Florida, 32256, United States
Multispecialty Research Associates
Lake City, Florida, 32055, United States
ClinCloud
Maitland, Florida, 32751, United States
Premier Clinical Reserch Institute, INC
Miami, Florida, 33122, United States
QPS MRA
Miami, Florida, 33143, United States
Applemed Research Group
Miami, Florida, 33155, United States
Biotech Pharmaceuticals Group
Miami, Florida, 33155, United States
Behavioral Clinical Research
North Miami, Florida, 33161, United States
Sensible Health
Ocoee, Florida, 34761, United States
Accel - Orange City
Orange City, Florida, 32763, United States
CNS Health Care - Orlando
Orlando, Florida, 32801, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174, United States
Infinity Clinical Research, LLC
Sunrise, Florida, 33351, United States
Precision Clinical Research
Sunrise, Florida, 33351, United States
Clinical Research CF
Winter Haven, Florida, 33880, United States
Conquest Research
Winter Park, Florida, 32789, United States
Neuro Studios
Decatur, Georgia, 30033, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
PMG Research of DuPage Medical Group
Downers Grove, Illinois, 60515, United States
Healthcare Research Network II, LLC
Flossmoor, Illinois, 60422, United States
Phoenix Medical Reserch
Prairie Village, Kansas, 66208, United States
Delricht - Baton Rouge
Baton Rouge, Louisiana, 70816, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Delricht - NewOrleans
New Orleans, Louisiana, 70124, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
BTC of New Bedford
New Bedford, Massachusetts, 02740, United States
Medvadis Research Group
Watertown, Massachusetts, 02472, United States
Michigan Headache and Neurological Institute
Ann Arbor, Michigan, 48104, United States
Michigan Pain Consultants
Wyoming, Michigan, 49519, United States
Minneapolis Clinic of Neurology
Burnsville, Minnesota, 55337, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Healthcare Research Network II, LLC
Hazelwood, Missouri, 63042, United States
Clinvest Research
Springfield, Missouri, 65810, United States
Montana Medical Research
Missoula, Montana, 59808, United States
Quality Clinical Research
Omaha, Nebraska, 68114, United States
Altea Research
Las Vegas, Nevada, 89102, United States
Wake Research-Clinical Research Center of Nevada
Las Vegas, Nevada, 89118, United States
Clinical Research of South Nevada
Las Vegas, Nevada, 89121, United States
Dartmouth-Hitchcock Clinical Trials Office
Lebanon, New Hampshire, 03756, United States
Hassman Research Institute
Berlin, New Jersey, 08009, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87109, United States
Albuquerque Neuroscience
Albuquerque, New Mexico, 87109, United States
SPRI Clinical Trials
Brooklyn, New York, 11235, United States
Manhattan Behavioral Medicine
New York, New York, 10036, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
Montefiori Medical Center
The Bronx, New York, 10461, United States
Upstate Clinical Research Associates
Williamsville, New York, 14221, United States
Headache Wellness Center - Greensboro
Greensboro, North Carolina, 27405, United States
PharmQuest
Greensboro, North Carolina, 27408, United States
M3-Wake Research
Raleigh, North Carolina, 27612, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
Lillestol Research
Fargo, North Dakota, 58104, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Rapid Medical Research Inc.
Cleveland, Ohio, 44122, United States
Aventiv Research
Columbus, Ohio, 43213, United States
Neurology Diagnosis
Dayton, Ohio, 45459, United States
Delynn Institute
Oklahoma City, Oklahoma, 73112, United States
Delricht Research
Tulsa, Oklahoma, 74133, United States
Thomas Jefferson University/Jefferson Headache Center
Philadelphia, Pennsylvania, 19107, United States
CNS Research Inc - Rhode Island
Rumford, Rhode Island, 02916, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
WR-ClinSearch
Chattanooga, Tennessee, 37421, United States
CNS Healthcare
Memphis, Tennessee, 38119, United States
Clinical Research Associates
Nashville, Tennessee, 37203, United States
Nashville Neuroscience Group
Nashville, Tennessee, 37203, United States
Wellness Clinical Research
Allen, Texas, 75013, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
Future Search Trials
Dallas, Texas, 75231, United States
HRMD Research
Dallas, Texas, 75240, United States
Texas Center for Drug Development
Houston, Texas, 77081, United States
SMS Clinical Research
Mesquite, Texas, 75149, United States
DM Clinical Research
Tomball, Texas, 77375, United States
ClinPoint Trials
Waxahachie, Texas, 75165, United States
Aspen Clinical Research
Orem, Utah, 84058, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
Highland Clinical Research
Salt Lake City, Utah, 84124, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President of Regulatory Affairs and Quality
- Organization
- Satsuma Pharmaceuticals, Inc.
Study Officials
- STUDY CHAIR
Detlef Albrecht, MD
Satsuma Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2019
First Posted
April 3, 2019
Study Start
June 24, 2019
Primary Completion
July 31, 2020
Study Completion
August 13, 2020
Last Updated
June 29, 2023
Results First Posted
June 29, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share