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

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

Study Overview

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

Detailed Description

The EMERGE trial 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): 1201
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics
    • Birmingham, Alabama, United States, 35216
      • Accel Clinical - Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Arizona Research Center
    • Phoenix, Arizona, United States, 85018
      • Elite Clinical Studies
    • Phoenix, Arizona, United States, 85012
      • Alea Research
    • Tucson, Arizona, United States, 85710
      • Tucson Neuroscience Research
  • California
    • Carlsbad, California, United States, 92011
      • The Research Center of Southern California
    • Carmichael, California, United States, 95608
      • Med Center Medical Clinic
    • Encino, California, United States, 91316
      • WR-PRI
    • Huntington Beach, California, United States, 92647
      • Marvel Clinical Research
    • La Mesa, California, United States, 91942
      • eStudySite
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience
    • Los Alamitos, California, United States, 90720
      • WP-PRI
    • Los Angeles, California, United States, 90017
      • Downtown LA Research
    • Los Angeles, California, United States, 90024
      • Cal Neuro Research Group
    • Newport Beach, California, United States, 92660
      • WR-PRI
    • Oakland, California, United States, 94607
      • Alliance Sites
    • Palo Alto, California, United States, 94304
      • Stanford Neuroscience Health Center
    • Panorama City, California, United States, 91402
      • National Research Institute
    • Pomona, California, United States, 91767
      • Empire Clinical Reserch
    • Riverside, California, United States, 92503
      • Artemis Institute for Clinical Research- Riverside
    • San Diego, California, United States, 92103
      • Pacific Research Network
    • San Diego, California, United States, 92103
      • Artemis Institute of Clinical Research - San Diego
    • San Diego, California, United States, 92108
      • WR-MCCR
    • San Francisco, California, United States, 94102
      • Optimus Medical Group
    • San Marcos, California, United States, 92103
      • Artemis Institute for Clinical Research- San Marcos
    • Santa Monica, California, United States, 90404
      • Neurological Research Institute
    • Sherman Oaks, California, United States, 91403
      • Schuster Medical Research Institute
    • Simi Valley, California, United States, 93065
      • Southern California Research
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research
  • Connecticut
    • East Hartford, Connecticut, United States, 06118
      • Hartford Headache Center
    • Hamden, Connecticut, United States, 06517
      • CMR of Greater New Haven
    • Stamford, Connecticut, United States, 06905
      • New England Institute for Neurology and Headache
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research
  • Florida
    • DeLand, Florida, United States, 32720
      • Accel Clinical - DeLand
    • Fort Myers, Florida, United States, 33912
      • Gulf Coast Clinical Research
    • Hallandale Beach, Florida, United States, 33009
      • MD Clinical
    • Hialeah, Florida, United States, 33012
      • AGA Clinical Trials
    • Hialeah, Florida, United States, 33016
      • Galiz Research- Hialeah
    • Hollywood, Florida, United States, 33024
      • Research Centers of America
    • Jacksonville, Florida, United States, 32256
      • CNS Healthcare
    • Lake City, Florida, United States, 32055
      • Multispecialty Research Associates
    • Maitland, Florida, United States, 32751
      • ClinCloud
    • Miami, Florida, United States, 33122
      • Premier Clinical Reserch Institute, INC
    • Miami, Florida, United States, 33143
      • QPS MRA
    • Miami, Florida, United States, 33155
      • AppleMed Research Group
    • Miami, Florida, United States, 33155
      • Biotech Pharmaceuticals Group
    • North Miami, Florida, United States, 33161
      • Behavioral Clinical Research
    • Ocoee, Florida, United States, 34761
      • Sensible Health
    • Orange City, Florida, United States, 32763
      • Accel - Orange City
    • Orlando, Florida, United States, 32801
      • CNS Health Care - Orlando
    • Ormond Beach, Florida, United States, 32174
      • Neurology Associates of Ormond Beach
    • Sunrise, Florida, United States, 33351
      • Precision Clinical Research
    • Sunrise, Florida, United States, 33351
      • Infinity Clinical Research, LLC
    • Winter Haven, Florida, United States, 33880
      • Clinical Research CF
    • Winter Park, Florida, United States, 32789
      • Conquest Research
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Neuro Studios
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Advanced Clinical Research
  • Illinois
    • Downers Grove, Illinois, United States, 60515
      • PMG Research of DuPage Medical Group
    • Flossmoor, Illinois, United States, 60422
      • Healthcare Research Network II, LLC
  • Kansas
    • Prairie Village, Kansas, United States, 66208
      • Phoenix Medical Reserch
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70816
      • Delricht - Baton Rouge
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research
    • New Orleans, Louisiana, United States, 70124
      • Delricht - NewOrleans
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • New Bedford, Massachusetts, United States, 02740
      • Btc of New Bedford
    • Watertown, Massachusetts, United States, 02472
      • Medvadis Research Group
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Headache and Neurological Institute
    • Wyoming, Michigan, United States, 49519
      • Michigan Pain Consultants
  • Minnesota
    • Burnsville, Minnesota, United States, 55337
      • Minneapolis Clinic of Neurology
  • Missouri
    • Hazelwood, Missouri, United States, 63042
      • Healthcare Research Network II, LLC
    • Saint Peters, Missouri, United States, 63303
      • StudyMetrix Research
    • Springfield, Missouri, United States, 65810
      • Clinvest Research
  • Montana
    • Missoula, Montana, United States, 59808
      • Montana Medical Research
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research
  • Nevada
    • Las Vegas, Nevada, United States, 89121
      • Clinical Research of South Nevada
    • Las Vegas, Nevada, United States, 89102
      • Altea Research
    • Las Vegas, Nevada, United States, 89118
      • Wake Research-Clinical Research Center of Nevada
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Clinical Trials Office
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Albuquerque Neuroscience
    • Albuquerque, New Mexico, United States, 87109
      • Albuquerque Clinical Trials
  • New York
    • Bronx, New York, United States, 10461
      • Montefiori Medical Center
    • Brooklyn, New York, United States, 11235
      • SPRI Clinical Trials
    • New York, New York, United States, 10036
      • Manhattan Behavioral Medicine
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • PharmQuest
    • Greensboro, North Carolina, United States, 27405
      • Headache Wellness Center - Greensboro
    • Raleigh, North Carolina, United States, 27612
      • M3-Wake Research
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Lillestol Research
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Research Center
    • Cleveland, Ohio, United States, 44122
      • Rapid Medical Research Inc.
    • Columbus, Ohio, United States, 43213
      • Aventiv Research
    • Dayton, Ohio, United States, 45459
      • Neurology Diagnosis
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Delynn Institute
    • Tulsa, Oklahoma, United States, 74133
      • DelRicht Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University/Jefferson Headache Center
  • Rhode Island
    • Rumford, Rhode Island, United States, 02916
      • CNS Research Inc - Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • WR-ClinSearch
    • Memphis, Tennessee, United States, 38119
      • CNS Healthcare
    • Nashville, Tennessee, United States, 37203
      • Nashville Neuroscience Group
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates
  • Texas
    • Allen, Texas, United States, 75013
      • Wellness Clinical Research
    • Austin, Texas, United States, 78731
      • FutureSearch Trials of Neurology
    • Dallas, Texas, United States, 75231
      • Future Search Trials
    • Dallas, Texas, United States, 75240
      • HRMD Research
    • Houston, Texas, United States, 77081
      • Texas Center for Drug Development
    • Mesquite, Texas, United States, 75149
      • SMS Clinical Research
    • Tomball, Texas, United States, 77375
      • DM Clinical Research
    • Waxahachie, Texas, United States, 75165
      • ClinPoint Trials
  • Utah
    • Orem, Utah, United States, 84058
      • Aspen Clinical Research
    • Salt Lake City, Utah, United States, 84124
      • Highland Clinical Research
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 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)

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STS101 Low Dose; STS101 (dihydroergotamine nasal powder), low dose	Drug: Dihydroergotamine; Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.; Other Names: Dihydroergotamine Mesylate
Experimental: STS101 High Dose; STS101 (dihydroergotamine nasal powder), high dose	Drug: Dihydroergotamine; Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.; Other Names: Dihydroergotamine Mesylate
Placebo Comparator: STS101 Placebo	Drug: Placebos; 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 24, 2019
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): August 13, 2020

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 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: STS101-002

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