A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine

ClinicalTrials.gov processed this data on November 21, 2023. Link to the current ClinicalTrials.gov record.

Recruitment Status

(See Contacts and Locations)
Verified November 2023 by Satsuma Pharmaceuticals, Inc.


Satsuma Pharmaceuticals, Inc.

Information Provided by (Responsible Party)

Satsuma Pharmaceuticals, Inc.

Clinicaltrials.gov Identifier

Other Study ID Numbers: STS101-007
First Submitted: June 17, 2021
First Posted: June 25, 2021
Results First Posted: July 24, 2023
Last Update Posted: November 27, 2023
Last Verified: November 2023
History of Changes

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Study 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).
Condition or Disease Intervention/Treatment
  • Migraine
  • Migraine With Aura
  • Migraine Without Aura
  • Drug: Dihydroergotamine
  • Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment1591 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
Primary PurposeTreatment
Official TitleA Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine
Study Start DateJune 30, 2021
Actual Primary Completion DateOctober 13, 2022
Actual Study Completion DateOctober 26, 2022

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • STS101
    • STS101 (dihydroergotamine nasal powder)
  • Drug: Dihydroergotamine
    • Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
  • STS101 Placebo
    • STS101 Placebo
  • Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. 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).
    2. 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

    1. 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)
    • Ke
    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.
    • MD First Research | Chandler, Arizona, United States, 85286
    • Elite Clinical Studies | Phoenix, Arizona, United States, 85018
    • Alliance For Multispecialty Research | Tempe, Arizona, United States, 85283
    • Cognitive Clinical Trials, LLC | Tempe, Arizona, United States, 85283
    • Clinedge, LLC | Tucson, Arizona, United States, 85704
    • ERG Clinical | Little Rock, Arkansas, United States, 72211
    • Hope Clinical Research | Canoga Park, California, United States, 91303
    • Wr-Pri, Llc | Encino, California, United States, 91316
    • Neuro-Pain Medical Center Ince | Fresno, California, United States, 93710
    • Estudy Site - La Mesa | La Mesa, California, United States, 91942
    • Wr-Pri Llc | Los Alamitos, California, United States, 90720
    • Downtown LA Research Center | Los Angeles, California, United States, 90017
    • Clinical Research Institute | Los Angeles, California, United States, 90048
    • Wr-Pri Llc | Newport Beach, California, United States, 92660
    • Artemis Institute for Clinical Research - San Diego | San Diego, California, United States, 92103
    • WR-MCCR | San Diego, California, United States, 92108
    • Acclaim Clinical Research | San Diego, California, United States, 92120
    • National Research Institute, A Clinical Research Organization | Santa Ana, California, United States, 92704
    • Alpine Clinical Research Center, Inc | Boulder, Colorado, United States, 80301
    • Clinedge, LLC | Cromwell, Connecticut, United States, 06416
    • Neurology Offices of South Florida | Boca Raton, Florida, United States, 33428
    • Velocity Clinical Research, Hallendale Beach | Hallandale Beach, Florida, United States, 33009
    • Infinity Clinical Research, LLC | Hollywood, Florida, United States, 33024
    • Elite Research Network, LLC a Florida LLC | Jacksonville, Florida, United States, 32216
    • Clinical Neuroscience Solutions, Inc | Jacksonville, Florida, United States, 32256
    • Elite Research Network LLC a Florida LLC | Jupiter, Florida, United States, 33458
    • Multi-Specialty Research Associates | Lake City, Florida, United States, 32055
    • Clinicloud | Maitland, Florida, United States, 32751
    • Next Phase Research | Miami, Florida, United States, 33144
    • Applemed Research Group | Miami, Florida, United States, 33155
    • Biotech Pharmaceuticals Group LLC | Miami, Florida, United States, 33155
    • Novel Clinical Research Center LLC | Miami, Florida, United States, 33173
    • Floridian Research | Miami, Florida, United States, 33179
    • Behavioral Clinical Research | North Miami, Florida, United States, 33161
    • Accel-Orange City | Orange City, Florida, United States, 32763
    • CNS Health Care Orlando | Orlando, Florida, United States, 32801
    • Complete Health Research | Ormond Beach, Florida, United States, 32174
    • Oveido Medical Research | Oviedo, Florida, United States, 32765
    • Santos Research Center | Tampa, Florida, United States, 33603
    • VICIS Clinical Research, Inc | Tampa, Florida, United States, 33615
    • Palm Beach Research | West Palm Beach, Florida, United States, 33409
    • Conquest Research, LLC | Winter Park, Florida, United States, 32789
    • Delricht | Atlanta, Georgia, United States, 30329
    • I-Research Atlanta | Decatur, Georgia, United States, 30030
    • Alpha Clinical Research Georgia | Johns Creek, Georgia, United States, 30022
    • Clin-Edge, LLC | Marietta, Georgia, United States, 30060
    • I Research Savannah | Savannah, Georgia, United States, 31405
    • Advanced Clinical Research | Meridian, Idaho, United States, 83642
    • CIS Research | Wauconda, Illinois, United States, 60084
    • Medisphere Medical Research Center | Evansville, Indiana, United States, 47714
    • PMG Research Inc | Ames, Iowa, United States, 50010
    • Meridian Clinical Research | Sioux City, Iowa, United States, 51106
    • Integrated Clinical Trial SVC | West Des Moines, Iowa, United States, 50265
    • Alliance For Multispecialty Research | Lexington, Kentucky, United States, 40509
    • Louisville Metabolic & Atherosclerosis Research Center | Louisville, Kentucky, United States, 40213
    • Delricht Research | Baton Rouge, Louisiana, United States, 70817
    • Crescent City Headache and Neurology | Chalmette, Louisiana, United States, 70043
    • Delricht | Covington, Louisiana, United States, 70433
    • Alliance for Multispecialty Research | New Orleans, Louisiana, United States, 70119
    • Delricht-New Orleans | New Orleans, Louisiana, United States, 70124
    • Boston Clinical Trials | Boston, Massachusetts, United States, 02131
    • BTC of New Bedford | New Bedford, Massachusetts, United States, 02740
    • Northeast Medical Research Associates | North Dartmouth, Massachusetts, United States, 02747
    • "Medvadis Research Corp, Llc @Boston Paincare Center " | Waltham, Massachusetts, United States, 02451
    • MHNI | Ann Arbor, Michigan, United States, 48104
    • Minneapolis Clinic of Neurology | Burnsville, Minnesota, United States, 55337
    • Delricht | Gulfport, Mississippi, United States, 39503
    • Alliance for Multispecialty Research | Kansas City, Missouri, United States, 64114
    • Montana Medical Research, Inc | Missoula, Montana, United States, 59808
    • Skyline Medical Center, PC CCT Research | Elkhorn, Nebraska, United States, 68022
    • Cognitive Clinical Trials, LLC | Fremont, Nebraska, United States, 68025
    • Quality Clinical Research, Inc | Omaha, Nebraska, United States, 68114
    • Excel Clinical Research | Las Vegas, Nevada, United States, 89109
    • Wake Research-Clinical Research Center of Nevada LLC | Las Vegas, Nevada, United States, 89118
    • Clinedge LLC | North Las Vegas, Nevada, United States, 89030
    • Albuquerque Clinical Trials | Albuquerque, New Mexico, United States, 87102
    • Integrative Clinical Trials | Brooklyn, New York, United States, 11229
    • SPRI Clinical Trials, LLC | Brooklyn, New York, United States, 11235
    • North Suffolk Neurology | Commack, New York, United States, 11725
    • Drug Trials America | Hartsdale, New York, United States, 10530
    • Central New York Clinical Research | Manlius, New York, United States, 13104
    • Upstate Clinical Research Associates | Williamsville, New York, United States, 14221
    • PMG Research of Charlotte | Charlotte, North Carolina, United States, 28209
    • Onsite Clinical | Charlotte, North Carolina, United States, 28277
    • Headache Wellness Center - Greensboro | Greensboro, North Carolina, United States, 27405
    • Pharmquest, LLC | Greensboro, North Carolina, United States, 27408
    • Peters Medical Research | High Point, North Carolina, United States, 27262
    • North Carolina Clinical Research | Raleigh, North Carolina, United States, 27607
    • PMG Research, Inc | Raleigh, North Carolina, United States, 27609
    • PMG Research of Wilmington, LLC | Wilmington, North Carolina, United States, 28401
    • PMG Research Inc | Winston-Salem, North Carolina, United States, 27103
    • Plains Clinical Research | South West Fargo, North Dakota, United States, 58104
    • CTI Clinical Research Center | Cincinnati, Ohio, United States, 45212
    • Aventiv Research | Columbus, Ohio, United States, 43213
    • Aventiv Research, Inc | Dublin, Ohio, United States, 43016
    • OK Clinical Research | Edmond, Oklahoma, United States, 73034
    • Elite Research Network, LLC a Florida LLC | Norman, Oklahoma, United States, 73072
    • Hightower Clinical | Oklahoma City, Oklahoma, United States, 73134
    • Delricht Research | Tulsa, Oklahoma, United States, 74133
    • Tekton Research | Yukon, Oklahoma, United States, 73099
    • Suburban Research Associates | Media, Pennsylvania, United States, 19063
    • Ocean State Clinical Research Partners | Lincoln, Rhode Island, United States, 02865
    • Velocity Clinical Research.- Providence | Warwick, Rhode Island, United States, 02886
    • Clinedge LLC - Clinical Trials SSC | Charleston, South Carolina, United States, 29406
    • Tribe CR | Greenville, South Carolina, United States, 29607
    • Coastal Carolina Research Center Inc | North Charleston, South Carolina, United States, 29405
    • Hillcrest Clinical Research | Simpsonville, South Carolina, United States, 29681
    • Internal Medicine and Pediatric Associates of Bristol, PC | Bristol, Tennessee, United States, 37620
    • New Phase Research & Development | Knoxville, Tennessee, United States, 37909
    • Clinical Research Associates, Inc | Nashville, Tennessee, United States, 37203
    • Future Search Trials of Neurology | Austin, Texas, United States, 78731
    • Premier Family Physicians | Austin, Texas, United States, 78735
    • Discoveresearch | Bryan, Texas, United States, 77802
    • Future Search Trials of Dallas, LP | Dallas, Texas, United States, 75231
    • Cedar Health Research, LLC | Dallas, Texas, United States, 75251
    • North Texas Institute of Neurology | Frisco, Texas, United States, 75034
    • Epic Clinical Research | Lewisville, Texas, United States, 75057
    • DM Clinical Research | Magnolia, Texas, United States, 77355
    • Village Health Partners | Plano, Texas, United States, 75024
    • Sun Research | San Antonio, Texas, United States, 78215
    • DM Clinical Research | Tomball, Texas, United States, 77375
    • Advanced Research Institute | Ogden, Utah, United States, 84405
    • Charlottesville Medical Research | Charlottesville, Virginia, United States, 22911
    • Alliance For Multispecialty Research | Norfolk, Virginia, United States, 23502
    • Tidewater Integrated Medical Research | Virginia Beach, Virginia, United States, 23454
    • Northwest Clinical Research Center | Bellevue, Washington, United States, 98007
    • Seattle Womens | Seattle, Washington, United States, 98105

      Study Documents (Full Text)

      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