A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine
- Conditions
- Migraine With AuraMigraine Without AuraMigraine
- Interventions
- Drug: DihydroergotamineDrug: Placebo
- Registration Number
- NCT04940390
- Lead Sponsor
- Satsuma Pharmaceuticals, Inc.
- 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.
- Detailed Description
Study STS101-007 is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study in subjects with acute migraine (ages 18 to 65 years).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1591
- 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)
Key
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description STS101 Dihydroergotamine STS101 (dihydroergotamine nasal powder) STS101 Placebo Placebo STS101 Placebo
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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).
Trial Locations
- Locations (115)
DM Clinical Research
🇺🇸Tomball, Texas, United States
Downtown LA Research Center
🇺🇸Los Angeles, California, United States
Palm Beach Research
🇺🇸West Palm Beach, Florida, United States
New Phase Research & Development
🇺🇸Knoxville, Tennessee, United States
BTC of New Bedford
🇺🇸New Bedford, Massachusetts, United States
Next Phase Research
🇺🇸Miami, Florida, United States
Applemed Research Group
🇺🇸Miami, Florida, United States
Floridian Research
🇺🇸Miami, Florida, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Biotech Pharmaceuticals Group LLC
🇺🇸Miami, Florida, United States
Accel-Orange City
🇺🇸Orange City, Florida, United States
Tribe CR
🇺🇸Greenville, South Carolina, United States
Delricht
🇺🇸Gulfport, Mississippi, United States
Northeast Medical Research Associates
🇺🇸North Dartmouth, Massachusetts, United States
"Medvadis Research Corp, Llc @Boston Paincare Center "
🇺🇸Waltham, Massachusetts, United States
Skyline Medical Center, PC CCT Research
🇺🇸Elkhorn, Nebraska, United States
PMG Research of Wilmington, LLC
🇺🇸Wilmington, North Carolina, United States
Coastal Carolina Research Center Inc
🇺🇸North Charleston, South Carolina, United States
Alpine Clinical Research Center, Inc
🇺🇸Boulder, Colorado, United States
Plains Clinical Research
🇺🇸South West Fargo, North Dakota, United States
Minneapolis Clinic of Neurology
🇺🇸Burnsville, Minnesota, United States
Clinical Research Associates, Inc
🇺🇸Nashville, Tennessee, United States
Alliance For Multispecialty Research
🇺🇸Norfolk, Virginia, United States
Wr-Pri, Llc
🇺🇸Encino, California, United States
Neuro-Pain Medical Center Ince
🇺🇸Fresno, California, United States
Hope Clinical Research
🇺🇸Canoga Park, California, United States
Artemis Institute for Clinical Research - San Diego
🇺🇸San Diego, California, United States
Estudy Site - La Mesa
🇺🇸La Mesa, California, United States
Clinical Research Institute
🇺🇸Los Angeles, California, United States
Elite Research Network, LLC a Florida LLC
🇺🇸Norman, Oklahoma, United States
Wr-Pri Llc
🇺🇸Newport Beach, California, United States
WR-MCCR
🇺🇸San Diego, California, United States
Acclaim Clinical Research
🇺🇸San Diego, California, United States
National Research Institute, A Clinical Research Organization
🇺🇸Santa Ana, California, United States
Clin-Edge, LLC
🇺🇸Marietta, Georgia, United States
I Research Savannah
🇺🇸Savannah, Georgia, United States
I-Research Atlanta
🇺🇸Decatur, Georgia, United States
CIS Research
🇺🇸Wauconda, Illinois, United States
Medisphere Medical Research Center
🇺🇸Evansville, Indiana, United States
Meridian Clinical Research
🇺🇸Sioux City, Iowa, United States
Delricht Research
🇺🇸Tulsa, Oklahoma, United States
Integrative Clinical Trials
🇺🇸Brooklyn, New York, United States
SPRI Clinical Trials, LLC
🇺🇸Brooklyn, New York, United States
North Suffolk Neurology
🇺🇸Commack, New York, United States
Albuquerque Clinical Trials
🇺🇸Albuquerque, New Mexico, United States
North Carolina Clinical Research
🇺🇸Raleigh, North Carolina, United States
PMG Research, Inc
🇺🇸Raleigh, North Carolina, United States
PMG Research of Charlotte
🇺🇸Charlotte, North Carolina, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Headache Wellness Center - Greensboro
🇺🇸Greensboro, North Carolina, United States
Pharmquest, LLC
🇺🇸Greensboro, North Carolina, United States
Onsite Clinical
🇺🇸Charlotte, North Carolina, United States
Drug Trials America
🇺🇸Hartsdale, New York, United States
Peters Medical Research
🇺🇸High Point, North Carolina, United States
Central New York Clinical Research
🇺🇸Manlius, New York, United States
Upstate Clinical Research Associates
🇺🇸Williamsville, New York, United States
Aventiv Research, Inc
🇺🇸Dublin, Ohio, United States
Aventiv Research
🇺🇸Columbus, Ohio, United States
OK Clinical Research
🇺🇸Edmond, Oklahoma, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Future Search Trials of Dallas, LP
🇺🇸Dallas, Texas, United States
Cedar Health Research, LLC
🇺🇸Dallas, Texas, United States
Velocity Clinical Research.- Providence
🇺🇸Warwick, Rhode Island, United States
Discoveresearch
🇺🇸Bryan, Texas, United States
Epic Clinical Research
🇺🇸Lewisville, Texas, United States
Ocean State Clinical Research Partners
🇺🇸Lincoln, Rhode Island, United States
North Texas Institute of Neurology
🇺🇸Frisco, Texas, United States
Sun Research
🇺🇸San Antonio, Texas, United States
Tidewater Integrated Medical Research
🇺🇸Virginia Beach, Virginia, United States
Seattle Womens
🇺🇸Seattle, Washington, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Hightower Clinical
🇺🇸Oklahoma City, Oklahoma, United States
Clinedge, LLC
🇺🇸Cromwell, Connecticut, United States
Elite Clinical Studies
🇺🇸Phoenix, Arizona, United States
Oveido Medical Research
🇺🇸Oviedo, Florida, United States
Velocity Clinical Research, Hallendale Beach
🇺🇸Hallandale Beach, Florida, United States
Novel Clinical Research Center LLC
🇺🇸Miami, Florida, United States
Excel Clinical Research
🇺🇸Las Vegas, Nevada, United States
ERG Clinical
🇺🇸Little Rock, Arkansas, United States
Crescent City Headache and Neurology
🇺🇸Chalmette, Louisiana, United States
Clinical Neuroscience Solutions, Inc
🇺🇸Jacksonville, Florida, United States
Multi-Specialty Research Associates
🇺🇸Lake City, Florida, United States
Complete Health Research
🇺🇸Ormond Beach, Florida, United States
Advanced Clinical Research
🇺🇸Meridian, Idaho, United States
Cognitive Clinical Trials, LLC
🇺🇸Fremont, Nebraska, United States
MD First Research
🇺🇸Chandler, Arizona, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
Wake Research-Clinical Research Center of Nevada LLC
🇺🇸Las Vegas, Nevada, United States
Clinedge LLC
🇺🇸North Las Vegas, Nevada, United States
Infinity Clinical Research, LLC
🇺🇸Hollywood, Florida, United States
Elite Research Network LLC a Florida LLC
🇺🇸Jupiter, Florida, United States
Hillcrest Clinical Research
🇺🇸Simpsonville, South Carolina, United States
Neurology Offices of South Florida
🇺🇸Boca Raton, Florida, United States
Clinicloud
🇺🇸Maitland, Florida, United States
Internal Medicine and Pediatric Associates of Bristol, PC
🇺🇸Bristol, Tennessee, United States
Behavioral Clinical Research
🇺🇸North Miami, Florida, United States
Conquest Research, LLC
🇺🇸Winter Park, Florida, United States
Montana Medical Research, Inc
🇺🇸Missoula, Montana, United States
Quality Clinical Research, Inc
🇺🇸Omaha, Nebraska, United States
Santos Research Center
🇺🇸Tampa, Florida, United States
VICIS Clinical Research, Inc
🇺🇸Tampa, Florida, United States
CNS Health Care Orlando
🇺🇸Orlando, Florida, United States
PMG Research Inc
🇺🇸Winston-Salem, North Carolina, United States
MHNI
🇺🇸Ann Arbor, Michigan, United States
Alpha Clinical Research Georgia
🇺🇸Johns Creek, Georgia, United States
Louisville Metabolic & Atherosclerosis Research Center
🇺🇸Louisville, Kentucky, United States
Clinedge LLC - Clinical Trials SSC
🇺🇸Charleston, South Carolina, United States
Alliance for Multispecialty Research
🇺🇸Kansas City, Missouri, United States
Delricht-New Orleans
🇺🇸New Orleans, Louisiana, United States
Future Search Trials of Neurology
🇺🇸Austin, Texas, United States
Premier Family Physicians
🇺🇸Austin, Texas, United States
Tekton Research
🇺🇸Yukon, Oklahoma, United States
Village Health Partners
🇺🇸Plano, Texas, United States
Integrated Clinical Trial SVC
🇺🇸West Des Moines, Iowa, United States