A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine (SUMMIT)

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine; Migraine Without Aura; Migraine With Aura
• Intervention / Treatment: Drug: Dihydroergotamine; Drug: Placebo

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).

• Study Type: Interventional
• Enrollment (Actual): 1591
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key 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)

Key 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STS101; STS101 (dihydroergotamine nasal powder)	Drug: Dihydroergotamine; Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.; Other Names: Dihydroergotamine Mesylate
Experimental: STS101 Placebo	Drug: Placebo; Placebo for STS101; Other Names: STS101 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 Hours Post Dose

Collaborators and Investigators

• Sponsor: Satsuma Pharmaceuticals, Inc.
• Investigators: Study Chair: Detlef Albrecht, MD, Satsuma Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Actual): October 13, 2022
• Study Completion (Actual): October 26, 2022

Study Registration Dates

• First Submitted: June 17, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: migraine; dihydroergotamine; dihydroergotamine mesylate
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Migraine without Aura; Migraine with Aura; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Dopamine Agonists; Dopamine Agents; Vasoconstrictor Agents; Dihydroergotamine
• Other Study ID Numbers: STS101-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No