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

Migraine Clinical Trial

— EMERGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03901482
• Other study ID #: STS101-002
• Status: Completed
• Phase: Phase 3
• Start date: June 24, 2019
• Est. completion date: August 13, 2020

Study information

• Verified date: June 2023
• Source: Satsuma Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1201
• Est. completion date: August 13, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders
• Migraine With Aura
• Migraine Without Aura

Intervention

Drug:
• Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
• Placebos
Placebo for STS101

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials	Albuquerque	New Mexico
United States	Albuquerque Neuroscience	Albuquerque	New Mexico
United States	Wellness Clinical Research	Allen	Texas
United States	Michigan Headache and Neurological Institute	Ann Arbor	Michigan
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Delricht - Baton Rouge	Baton Rouge	Louisiana
United States	Hassman Research Institute	Berlin	New Jersey
United States	Accel Clinical - Birmingham	Birmingham	Alabama
United States	Alabama Clinical Therapeutics	Birmingham	Alabama
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Montefiori Medical Center	Bronx	New York
United States	SPRI Clinical Trials	Brooklyn	New York
United States	Minneapolis Clinic of Neurology	Burnsville	Minnesota
United States	The Research Center of Southern California	Carlsbad	California
United States	Med Center Medical Clinic	Carmichael	California
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	WR-ClinSearch	Chattanooga	Tennessee
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Rapid Medical Research Inc.	Cleveland	Ohio
United States	Aventiv Research	Columbus	Ohio
United States	Future Search Trials	Dallas	Texas
United States	HRMD Research	Dallas	Texas
United States	Neurology Diagnosis	Dayton	Ohio
United States	Neuro Studios	Decatur	Georgia
United States	Accel Clinical - DeLand	DeLand	Florida
United States	PMG Research of DuPage Medical Group	Downers Grove	Illinois
United States	Hartford Headache Center	East Hartford	Connecticut
United States	WR-PRI	Encino	California
United States	Lillestol Research	Fargo	North Dakota
United States	Healthcare Research Network II, LLC	Flossmoor	Illinois
United States	Gulf Coast Clinical Research	Fort Myers	Florida
United States	Headache Wellness Center - Greensboro	Greensboro	North Carolina
United States	PharmQuest	Greensboro	North Carolina
United States	MD Clinical	Hallandale Beach	Florida
United States	CMR of Greater New Haven	Hamden	Connecticut
United States	Healthcare Research Network II, LLC	Hazelwood	Missouri
United States	AGA Clinical Trials	Hialeah	Florida
United States	Galiz Research- Hialeah	Hialeah	Florida
United States	Research Centers of America	Hollywood	Florida
United States	Texas Center for Drug Development	Houston	Texas
United States	Marvel Clinical Research	Huntington Beach	California
United States	CNS Healthcare	Jacksonville	Florida
United States	eStudySite	La Mesa	California
United States	Multispecialty Research Associates	Lake City	Florida
United States	Altea Research	Las Vegas	Nevada
United States	Clinical Research of South Nevada	Las Vegas	Nevada
United States	Wake Research-Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Dartmouth-Hitchcock Clinical Trials Office	Lebanon	New Hampshire
United States	Collaborative Neuroscience	Long Beach	California
United States	WP-PRI	Los Alamitos	California
United States	Cal Neuro Research Group	Los Angeles	California
United States	Downtown LA Research	Los Angeles	California
United States	ClinCloud	Maitland	Florida
United States	Tandem Clinical Research	Marrero	Louisiana
United States	CNS Healthcare	Memphis	Tennessee
United States	Advanced Clinical Research	Meridian	Idaho
United States	SMS Clinical Research	Mesquite	Texas
United States	Applemed Research Group	Miami	Florida
United States	Biotech Pharmaceuticals Group	Miami	Florida
United States	Premier Clinical Reserch Institute, INC	Miami	Florida
United States	QPS MRA	Miami	Florida
United States	Montana Medical Research	Missoula	Montana
United States	Clinical Research Associates	Nashville	Tennessee
United States	Nashville Neuroscience Group	Nashville	Tennessee
United States	BTC of New Bedford	New Bedford	Massachusetts
United States	Delricht - NewOrleans	New Orleans	Louisiana
United States	Manhattan Behavioral Medicine	New York	New York
United States	WR-PRI	Newport Beach	California
United States	Behavioral Clinical Research	North Miami	Florida
United States	Alliance Sites	Oakland	California
United States	Sensible Health	Ocoee	Florida
United States	Delynn Institute	Oklahoma City	Oklahoma
United States	Quality Clinical Research	Omaha	Nebraska
United States	Accel - Orange City	Orange City	Florida
United States	Aspen Clinical Research	Orem	Utah
United States	CNS Health Care - Orlando	Orlando	Florida
United States	Neurology Associates of Ormond Beach	Ormond Beach	Florida
United States	Stanford Neuroscience Health Center	Palo Alto	California
United States	National Research Institute	Panorama City	California
United States	Thomas Jefferson University/Jefferson Headache Center	Philadelphia	Pennsylvania
United States	Alea Research	Phoenix	Arizona
United States	Arizona Research Center	Phoenix	Arizona
United States	Elite Clinical Studies	Phoenix	Arizona
United States	Empire Clinical Reserch	Pomona	California
United States	Phoenix Medical Reserch	Prairie Village	Kansas
United States	M3-Wake Research	Raleigh	North Carolina
United States	Artemis Institute for Clinical Research- Riverside	Riverside	California
United States	Rochester Clinical Research	Rochester	New York
United States	CNS Research Inc - Rhode Island	Rumford	Rhode Island
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Highland Clinical Research	Salt Lake City	Utah
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Artemis Institute of Clinical Research - San Diego	San Diego	California
United States	Pacific Research Network	San Diego	California
United States	WR-MCCR	San Diego	California
United States	Optimus Medical Group	San Francisco	California
United States	Artemis Institute for Clinical Research- San Marcos	San Marcos	California
United States	Neurological Research Institute	Santa Monica	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	Clinvest Research	Springfield	Missouri
United States	New England Institute for Neurology and Headache	Stamford	Connecticut
United States	Infinity Clinical Research, LLC	Sunrise	Florida
United States	Precision Clinical Research	Sunrise	Florida
United States	DM Clinical Research	Tomball	Texas
United States	Tucson Neuroscience Research	Tucson	Arizona
United States	Delricht Research	Tulsa	Oklahoma
United States	Omega Medical Research	Warwick	Rhode Island
United States	Chase Medical Research	Waterbury	Connecticut
United States	Medvadis Research Group	Watertown	Massachusetts
United States	ClinPoint Trials	Waxahachie	Texas
United States	Upstate Clinical Research Associates	Williamsville	New York
United States	PMG Research of Wilmington	Wilmington	North Carolina
United States	Clinical Research CF	Winter Haven	Florida
United States	Conquest Research	Winter Park	Florida
United States	Michigan Pain Consultants	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Satsuma Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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