A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine

Phase 3

Completed

• Conditions: Migraine; Migraine With Aura; Migraine Without Aura
• Interventions: Drug: Placebos; Drug: Dihydroergotamine

• Registration Number: NCT03901482
• Lead Sponsor: Satsuma Pharmaceuticals, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-03
• Study Start: 2019-06-24
• Primary Completion: 2020-07-31
• Study Completion: 2020-08-13
• Results First Submitted: 2023-04-19
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-09
• Last Update Submitted: 2023-06-09
• Results First Posted: 2023-06-29
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1201

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STS101 Placebo	Placebos	STS101 Placebo
STS101 High Dose	Dihydroergotamine	STS101 (dihydroergotamine nasal powder), high dose
STS101 Low Dose	Dihydroergotamine	STS101 (dihydroergotamine nasal powder), low dose

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 (114)

Thomas Jefferson University/Jefferson Headache Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Cal Neuro Research Group; 🇺🇸 Los Angeles, California, United States

Rapid Medical Research Inc.; 🇺🇸 Cleveland, Ohio, United States

Elite Clinical Studies; 🇺🇸 Phoenix, Arizona, United States

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Alea Research; 🇺🇸 Phoenix, Arizona, United States

Artemis Institute of Clinical Research - San Diego; 🇺🇸 San Diego, California, United States

WR-MCCR; 🇺🇸 San Diego, California, United States

Pacific Research Network; 🇺🇸 San Diego, California, United States

Delynn Institute; 🇺🇸 Oklahoma City, Oklahoma, United States

Clinical Research Associates; 🇺🇸 Nashville, Tennessee, United States

Nashville Neuroscience Group; 🇺🇸 Nashville, Tennessee, United States

Wasatch Clinical Research; 🇺🇸 Salt Lake City, Utah, United States

Tucson Neuroscience Research; 🇺🇸 Tucson, Arizona, United States

Alabama Clinical Therapeutics; 🇺🇸 Birmingham, Alabama, United States

New England Institute for Neurology and Headache; 🇺🇸 Stamford, Connecticut, United States

Lillestol Research; 🇺🇸 Fargo, North Dakota, United States

Boston Clinical Trials; 🇺🇸 Boston, Massachusetts, United States

Advanced Clinical Research; 🇺🇸 Meridian, Idaho, United States

PharmQuest; 🇺🇸 Greensboro, North Carolina, United States

QPS MRA; 🇺🇸 Miami, Florida, United States

Galiz Research- Hialeah; 🇺🇸 Hialeah, Florida, United States

CMR of Greater New Haven; 🇺🇸 Hamden, Connecticut, United States

Chase Medical Research; 🇺🇸 Waterbury, Connecticut, United States

MD Clinical; 🇺🇸 Hallandale Beach, Florida, United States

ClinCloud; 🇺🇸 Maitland, Florida, United States

Accel Clinical - DeLand; 🇺🇸 DeLand, Florida, United States

CNS Healthcare; 🇺🇸 Memphis, Tennessee, United States

Gulf Coast Clinical Research; 🇺🇸 Fort Myers, Florida, United States

AGA Clinical Trials; 🇺🇸 Hialeah, Florida, United States

Research Centers of America; 🇺🇸 Hollywood, Florida, United States

Behavioral Clinical Research; 🇺🇸 North Miami, Florida, United States

Conquest Research; 🇺🇸 Winter Park, Florida, United States

Accel - Orange City; 🇺🇸 Orange City, Florida, United States

Phoenix Medical Reserch; 🇺🇸 Prairie Village, Kansas, United States

Biotech Pharmaceuticals Group; 🇺🇸 Miami, Florida, United States

Clinical Research of South Nevada; 🇺🇸 Las Vegas, Nevada, United States

Tandem Clinical Research; 🇺🇸 Marrero, Louisiana, United States

Altea Research; 🇺🇸 Las Vegas, Nevada, United States

Highland Clinical Research; 🇺🇸 Salt Lake City, Utah, United States

StudyMetrix Research; 🇺🇸 Saint Peters, Missouri, United States

PMG Research of DuPage Medical Group; 🇺🇸 Downers Grove, Illinois, United States

Manhattan Behavioral Medicine; 🇺🇸 New York, New York, United States

Montana Medical Research; 🇺🇸 Missoula, Montana, United States

Neuro Studios; 🇺🇸 Decatur, Georgia, United States

BTC of New Bedford; 🇺🇸 New Bedford, Massachusetts, United States

Wake Research-Clinical Research Center of Nevada; 🇺🇸 Las Vegas, Nevada, United States

Healthcare Research Network II, LLC; 🇺🇸 Hazelwood, Missouri, United States

Medvadis Research Group; 🇺🇸 Watertown, Massachusetts, United States

Delricht - Baton Rouge; 🇺🇸 Baton Rouge, Louisiana, United States

Hassman Research Institute; 🇺🇸 Berlin, New Jersey, United States

PMG Research of Wilmington; 🇺🇸 Wilmington, North Carolina, United States

Dartmouth-Hitchcock Clinical Trials Office; 🇺🇸 Lebanon, New Hampshire, United States

Headache Wellness Center - Greensboro; 🇺🇸 Greensboro, North Carolina, United States

WR-ClinSearch; 🇺🇸 Chattanooga, Tennessee, United States

Charlottesville Medical Research; 🇺🇸 Charlottesville, Virginia, United States

Aspen Clinical Research; 🇺🇸 Orem, Utah, United States

DM Clinical Research; 🇺🇸 Tomball, Texas, United States

Quality Clinical Research; 🇺🇸 Omaha, Nebraska, United States

Clinvest Research; 🇺🇸 Springfield, Missouri, United States

Delricht Research; 🇺🇸 Tulsa, Oklahoma, United States

Multispecialty Research Associates; 🇺🇸 Lake City, Florida, United States

Sensible Health; 🇺🇸 Ocoee, Florida, United States

Premier Clinical Reserch Institute, INC; 🇺🇸 Miami, Florida, United States

Applemed Research Group; 🇺🇸 Miami, Florida, United States

Neurology Associates of Ormond Beach; 🇺🇸 Ormond Beach, Florida, United States

Precision Clinical Research; 🇺🇸 Sunrise, Florida, United States

Clinical Research CF; 🇺🇸 Winter Haven, Florida, United States

Michigan Pain Consultants; 🇺🇸 Wyoming, Michigan, United States

M3-Wake Research; 🇺🇸 Raleigh, North Carolina, United States

CTI Clinical Research Center; 🇺🇸 Cincinnati, Ohio, United States

Aventiv Research; 🇺🇸 Columbus, Ohio, United States

Neurology Diagnosis; 🇺🇸 Dayton, Ohio, United States

Future Search Trials; 🇺🇸 Dallas, Texas, United States

HRMD Research; 🇺🇸 Dallas, Texas, United States

SMS Clinical Research; 🇺🇸 Mesquite, Texas, United States

Rochester Clinical Research; 🇺🇸 Rochester, New York, United States

Upstate Clinical Research Associates; 🇺🇸 Williamsville, New York, United States

CNS Research Inc - Rhode Island; 🇺🇸 Rumford, Rhode Island, United States

Omega Medical Research; 🇺🇸 Warwick, Rhode Island, United States

Infinity Clinical Research, LLC; 🇺🇸 Sunrise, Florida, United States

Minneapolis Clinic of Neurology; 🇺🇸 Burnsville, Minnesota, United States

SPRI Clinical Trials; 🇺🇸 Brooklyn, New York, United States

Texas Center for Drug Development; 🇺🇸 Houston, Texas, United States

Accel Clinical - Birmingham; 🇺🇸 Birmingham, Alabama, United States

The Research Center of Southern California; 🇺🇸 Carlsbad, California, United States

Med Center Medical Clinic; 🇺🇸 Carmichael, California, United States

Marvel Clinical Research; 🇺🇸 Huntington Beach, California, United States

eStudySite; 🇺🇸 La Mesa, California, United States

WP-PRI; 🇺🇸 Los Alamitos, California, United States

Collaborative Neuroscience; 🇺🇸 Long Beach, California, United States

Alliance Sites; 🇺🇸 Oakland, California, United States

Downtown LA Research; 🇺🇸 Los Angeles, California, United States

Empire Clinical Reserch; 🇺🇸 Pomona, California, United States

Stanford Neuroscience Health Center; 🇺🇸 Palo Alto, California, United States

National Research Institute; 🇺🇸 Panorama City, California, United States

Artemis Institute for Clinical Research- Riverside; 🇺🇸 Riverside, California, United States

Optimus Medical Group; 🇺🇸 San Francisco, California, United States

Artemis Institute for Clinical Research- San Marcos; 🇺🇸 San Marcos, California, United States

Schuster Medical Research Institute; 🇺🇸 Sherman Oaks, California, United States

Southern California Research; 🇺🇸 Simi Valley, California, United States

Encompass Clinical Research; 🇺🇸 Spring Valley, California, United States

Hartford Headache Center; 🇺🇸 East Hartford, Connecticut, United States

Neurological Research Institute; 🇺🇸 Santa Monica, California, United States

WR-PRI; 🇺🇸 Newport Beach, California, United States

CNS Health Care - Orlando; 🇺🇸 Orlando, Florida, United States

Michigan Headache and Neurological Institute; 🇺🇸 Ann Arbor, Michigan, United States

Albuquerque Clinical Trials; 🇺🇸 Albuquerque, New Mexico, United States

Delricht - NewOrleans; 🇺🇸 New Orleans, Louisiana, United States

Albuquerque Neuroscience; 🇺🇸 Albuquerque, New Mexico, United States

Montefiori Medical Center; 🇺🇸 Bronx, New York, United States

FutureSearch Trials of Neurology; 🇺🇸 Austin, Texas, United States

ClinPoint Trials; 🇺🇸 Waxahachie, Texas, United States

Wellness Clinical Research; 🇺🇸 Allen, Texas, United States