A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine
SUMMIT
1 other identifier
interventional
1,591
1 country
127
Brief 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.
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 2021
Shorter than P25 for phase_3
127 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
June 17, 2021
CompletedFirst Posted
Study publicly available on registry
June 25, 2021
CompletedStudy Start
First participant enrolled
June 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2022
CompletedResults Posted
Study results publicly available
July 24, 2023
CompletedNovember 27, 2023
November 1, 2023
1.3 years
June 17, 2021
June 12, 2023
November 21, 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 (2)
STS101
EXPERIMENTALSTS101 (dihydroergotamine nasal powder)
STS101 Placebo
EXPERIMENTALSTS101 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 (127)
MD First Research
Chandler, Arizona, 85286, United States
Elite Clinical Studies
Phoenix, Arizona, 85018, United States
Alliance For Multispecialty Research
Tempe, Arizona, 85283, United States
Cognitive Clinical Trials, LLC
Tempe, Arizona, 85283, United States
Clinedge, LLC
Tucson, Arizona, 85704, United States
ERG Clinical
Little Rock, Arkansas, 72211, United States
Hope Clinical Research
Canoga Park, California, 91303, United States
Wr-Pri, Llc
Encino, California, 91316, United States
Neuro-Pain Medical Center Ince
Fresno, California, 93710, United States
Estudy Site - La Mesa
La Mesa, California, 91942, United States
Wr-Pri Llc
Los Alamitos, California, 90720, United States
Downtown LA Research Center
Los Angeles, California, 90017, United States
Clinical Research Institute
Los Angeles, California, 90048, United States
Wr-Pri Llc
Newport Beach, California, 92660, United States
Artemis Institute for Clinical Research - San Diego
San Diego, California, 92103, United States
WR-MCCR
San Diego, California, 92108, United States
Acclaim Clinical Research
San Diego, California, 92120, United States
National Research Institute, A Clinical Research Organization
Santa Ana, California, 92704, United States
Alpine Clinical Research Center, Inc
Boulder, Colorado, 80301, United States
Clinedge, LLC
Cromwell, Connecticut, 06416, United States
Neurology Offices of South Florida
Boca Raton, Florida, 33428, United States
Velocity Clinical Research, Hallendale Beach
Hallandale, Florida, 33009, United States
Infinity Clinical Research, LLC
Hollywood, Florida, 33024, United States
Elite Research Network, LLC a Florida LLC
Jacksonville, Florida, 32216, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256, United States
Elite Research Network LLC a Florida LLC
Jupiter, Florida, 33458, United States
Multi-Specialty Research Associates
Lake City, Florida, 32055, United States
Clinicloud
Maitland, Florida, 32751, United States
Next Phase Research
Miami, Florida, 33144, United States
Applemed Research Group
Miami, Florida, 33155, United States
Biotech Pharmaceuticals Group LLC
Miami, Florida, 33155, United States
Novel Clinical Research Center LLC
Miami, Florida, 33173, United States
Floridian Research
Miami, Florida, 33179, United States
Behavioral Clinical Research
North Miami, Florida, 33161, United States
Accel-Orange City
Orange City, Florida, 32763, United States
CNS Health Care Orlando
Orlando, Florida, 32801, United States
Complete Health Research
Ormond Beach, Florida, 32174, United States
Oveido Medical Research
Oviedo, Florida, 32765, United States
Santos Research Center
Tampa, Florida, 33603, United States
VICIS Clinical Research, Inc
Tampa, Florida, 33615, United States
Palm Beach Research
West Palm Beach, Florida, 33409, United States
Conquest Research, LLC
Winter Park, Florida, 32789, United States
Delricht
Atlanta, Georgia, 30329, United States
I-Research Atlanta
Decatur, Georgia, 30030, United States
Alpha Clinical Research Georgia
Johns Creek, Georgia, 30022, United States
Clin-Edge, LLC
Marietta, Georgia, 30060, United States
I Research Savannah
Savannah, Georgia, 31405, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
CIS Research
Wauconda, Illinois, 60084, United States
Medisphere Medical Research Center
Evansville, Indiana, 47714, United States
PMG Research Inc
Ames, Iowa, 50010, United States
Meridian Clinical Research
Sioux City, Iowa, 51106, United States
Integrated Clinical Trial SVC
West Des Moines, Iowa, 50265, United States
Alliance For Multispecialty Research
Lexington, Kentucky, 40509, United States
Louisville Metabolic & Atherosclerosis Research Center
Louisville, Kentucky, 40213, United States
Delricht Research
Baton Rouge, Louisiana, 70817, United States
Crescent City Headache and Neurology
Chalmette, Louisiana, 70043, United States
Delricht
Covington, Louisiana, 70433, United States
Alliance for Multispecialty Research
New Orleans, Louisiana, 70119, United States
Delricht-New Orleans
New Orleans, Louisiana, 70124, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
BTC of New Bedford
New Bedford, Massachusetts, 02740, United States
Northeast Medical Research Associates
North Dartmouth, Massachusetts, 02747, United States
"Medvadis Research Corp, Llc @Boston Paincare Center "
Waltham, Massachusetts, 02451, United States
MHNI
Ann Arbor, Michigan, 48104, United States
Minneapolis Clinic of Neurology
Burnsville, Minnesota, 55337, United States
Delricht
Gulfport, Mississippi, 39503, United States
Alliance for Multispecialty Research
Kansas City, Missouri, 64114, United States
Montana Medical Research, Inc
Missoula, Montana, 59808, United States
Skyline Medical Center, PC CCT Research
Elkhorn, Nebraska, 68022, United States
Cognitive Clinical Trials, LLC
Fremont, Nebraska, 68025, United States
Quality Clinical Research, Inc
Omaha, Nebraska, 68114, United States
Excel Clinical Research
Las Vegas, Nevada, 89109, United States
Wake Research-Clinical Research Center of Nevada LLC
Las Vegas, Nevada, 89118, United States
Clinedge LLC
North Las Vegas, Nevada, 89030, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102, United States
Integrative Clinical Trials
Brooklyn, New York, 11229, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235, United States
North Suffolk Neurology
Commack, New York, 11725, United States
Drug Trials America
Hartsdale, New York, 10530, United States
Central New York Clinical Research
Manlius, New York, 13104, United States
Upstate Clinical Research Associates
Williamsville, New York, 14221, United States
PMG Research of Charlotte
Charlotte, North Carolina, 28209, United States
Onsite Clinical
Charlotte, North Carolina, 28277, United States
Headache Wellness Center - Greensboro
Greensboro, North Carolina, 27405, United States
Pharmquest, LLC
Greensboro, North Carolina, 27408, United States
Peters Medical Research
High Point, North Carolina, 27262, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
PMG Research, Inc
Raleigh, North Carolina, 27609, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
PMG Research Inc
Winston-Salem, North Carolina, 27103, United States
Plains Clinical Research
South West Fargo, North Dakota, 58104, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Aventiv Research
Columbus, Ohio, 43213, United States
Aventiv Research, Inc
Dublin, Ohio, 43016, United States
OK Clinical Research
Edmond, Oklahoma, 73034, United States
Elite Research Network, LLC a Florida LLC
Norman, Oklahoma, 73072, United States
Hightower Clinical
Oklahoma City, Oklahoma, 73134, United States
Delricht Research
Tulsa, Oklahoma, 74133, United States
Tekton Research
Yukon, Oklahoma, 73099, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Ocean State Clinical Research Partners
Lincoln, Rhode Island, 02865, United States
Velocity Clinical Research.- Providence
Warwick, Rhode Island, 02886, United States
Clinedge LLC - Clinical Trials SSC
Charleston, South Carolina, 29406, United States
Tribe CR
Greenville, South Carolina, 29607, United States
Coastal Carolina Research Center Inc
North Charleston, South Carolina, 29405, United States
Hillcrest Clinical Research
Simpsonville, South Carolina, 29681, United States
Internal Medicine and Pediatric Associates of Bristol, PC
Bristol, Tennessee, 37620, United States
New Phase Research & Development
Knoxville, Tennessee, 37909, United States
Clinical Research Associates, Inc
Nashville, Tennessee, 37203, United States
Future Search Trials of Neurology
Austin, Texas, 78731, United States
Premier Family Physicians
Austin, Texas, 78735, United States
Discoveresearch
Bryan, Texas, 77802, United States
Future Search Trials of Dallas, LP
Dallas, Texas, 75231, United States
Cedar Health Research, LLC
Dallas, Texas, 75251, United States
North Texas Institute of Neurology
Frisco, Texas, 75034, United States
Epic Clinical Research
Lewisville, Texas, 75057, United States
DM Clinical Research
Magnolia, Texas, 77355, United States
Village Health Partners
Plano, Texas, 75024, United States
Sun Research
San Antonio, Texas, 78215, United States
DM Clinical Research
Tomball, Texas, 77375, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Alliance For Multispecialty Research
Norfolk, Virginia, 23502, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Seattle Womens
Seattle, Washington, 98105, 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
June 17, 2021
First Posted
June 25, 2021
Study Start
June 30, 2021
Primary Completion
October 13, 2022
Study Completion
October 26, 2022
Last Updated
November 27, 2023
Results First Posted
July 24, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share