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

Migraine Clinical Trial

— SUMMIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04940390
• Other study ID #: STS101-007
• Status: Completed
• Phase: Phase 3
• Start date: June 30, 2021
• Est. completion date: October 26, 2022

Study information

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

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1591
• Est. completion date: October 26, 2022
• Est. primary completion date: October 13, 2022
• 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)

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.

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.
• Placebo
Placebo for STS101

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials	Albuquerque	New Mexico
United States	PMG Research Inc	Ames	Iowa
United States	MHNI	Ann Arbor	Michigan
United States	Delricht	Atlanta	Georgia
United States	Future Search Trials of Neurology	Austin	Texas
United States	Premier Family Physicians	Austin	Texas
United States	Delricht Research	Baton Rouge	Louisiana
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Neurology Offices of South Florida	Boca Raton	Florida
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Alpine Clinical Research Center, Inc	Boulder	Colorado
United States	Internal Medicine and Pediatric Associates of Bristol, PC	Bristol	Tennessee
United States	Integrative Clinical Trials	Brooklyn	New York
United States	SPRI Clinical Trials, LLC	Brooklyn	New York
United States	Discoveresearch	Bryan	Texas
United States	Minneapolis Clinic of Neurology	Burnsville	Minnesota
United States	Hope Clinical Research	Canoga Park	California
United States	Crescent City Headache and Neurology	Chalmette	Louisiana
United States	MD First Research	Chandler	Arizona
United States	Clinedge LLC - Clinical Trials SSC	Charleston	South Carolina
United States	Onsite Clinical	Charlotte	North Carolina
United States	PMG Research of Charlotte	Charlotte	North Carolina
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Aventiv Research	Columbus	Ohio
United States	North Suffolk Neurology	Commack	New York
United States	Delricht	Covington	Louisiana
United States	Clinedge, LLC	Cromwell	Connecticut
United States	Cedar Health Research, LLC	Dallas	Texas
United States	Future Search Trials of Dallas, LP	Dallas	Texas
United States	I-Research Atlanta	Decatur	Georgia
United States	Aventiv Research, Inc	Dublin	Ohio
United States	OK Clinical Research	Edmond	Oklahoma
United States	Skyline Medical Center, PC CCT Research	Elkhorn	Nebraska
United States	Wr-Pri, Llc	Encino	California
United States	Medisphere Medical Research Center	Evansville	Indiana
United States	Cognitive Clinical Trials, LLC	Fremont	Nebraska
United States	Neuro-Pain Medical Center Ince	Fresno	California
United States	North Texas Institute of Neurology	Frisco	Texas
United States	Headache Wellness Center - Greensboro	Greensboro	North Carolina
United States	Pharmquest, LLC	Greensboro	North Carolina
United States	Tribe CR	Greenville	South Carolina
United States	Delricht	Gulfport	Mississippi
United States	Velocity Clinical Research, Hallendale Beach	Hallandale Beach	Florida
United States	Drug Trials America	Hartsdale	New York
United States	Peters Medical Research	High Point	North Carolina
United States	Infinity Clinical Research, LLC	Hollywood	Florida
United States	Clinical Neuroscience Solutions, Inc	Jacksonville	Florida
United States	Elite Research Network, LLC a Florida LLC	Jacksonville	Florida
United States	Alpha Clinical Research Georgia	Johns Creek	Georgia
United States	Elite Research Network LLC a Florida LLC	Jupiter	Florida
United States	Alliance for Multispecialty Research	Kansas City	Missouri
United States	New Phase Research & Development	Knoxville	Tennessee
United States	Estudy Site - La Mesa	La Mesa	California
United States	Multi-Specialty Research Associates	Lake City	Florida
United States	Excel Clinical Research	Las Vegas	Nevada
United States	Wake Research-Clinical Research Center of Nevada LLC	Las Vegas	Nevada
United States	Epic Clinical Research	Lewisville	Texas
United States	Alliance For Multispecialty Research	Lexington	Kentucky
United States	Ocean State Clinical Research Partners	Lincoln	Rhode Island
United States	ERG Clinical	Little Rock	Arkansas
United States	Wr-Pri Llc	Los Alamitos	California
United States	Clinical Research Institute	Los Angeles	California
United States	Downtown LA Research Center	Los Angeles	California
United States	Louisville Metabolic & Atherosclerosis Research Center	Louisville	Kentucky
United States	DM Clinical Research	Magnolia	Texas
United States	Clinicloud	Maitland	Florida
United States	Central New York Clinical Research	Manlius	New York
United States	Clin-Edge, LLC	Marietta	Georgia
United States	Suburban Research Associates	Media	Pennsylvania
United States	Advanced Clinical Research	Meridian	Idaho
United States	Applemed Research Group	Miami	Florida
United States	Biotech Pharmaceuticals Group LLC	Miami	Florida
United States	Floridian Research	Miami	Florida
United States	Next Phase Research	Miami	Florida
United States	Novel Clinical Research Center LLC	Miami	Florida
United States	Montana Medical Research, Inc	Missoula	Montana
United States	Clinical Research Associates, Inc	Nashville	Tennessee
United States	BTC of New Bedford	New Bedford	Massachusetts
United States	Alliance for Multispecialty Research	New Orleans	Louisiana
United States	Delricht-New Orleans	New Orleans	Louisiana
United States	Wr-Pri Llc	Newport Beach	California
United States	Alliance For Multispecialty Research	Norfolk	Virginia
United States	Elite Research Network, LLC a Florida LLC	Norman	Oklahoma
United States	Coastal Carolina Research Center Inc	North Charleston	South Carolina
United States	Northeast Medical Research Associates	North Dartmouth	Massachusetts
United States	Clinedge LLC	North Las Vegas	Nevada
United States	Behavioral Clinical Research	North Miami	Florida
United States	Advanced Research Institute	Ogden	Utah
United States	Hightower Clinical	Oklahoma City	Oklahoma
United States	Quality Clinical Research, Inc	Omaha	Nebraska
United States	Accel-Orange City	Orange City	Florida
United States	CNS Health Care Orlando	Orlando	Florida
United States	Complete Health Research	Ormond Beach	Florida
United States	Oveido Medical Research	Oviedo	Florida
United States	Elite Clinical Studies	Phoenix	Arizona
United States	Village Health Partners	Plano	Texas
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	PMG Research, Inc	Raleigh	North Carolina
United States	Sun Research	San Antonio	Texas
United States	Acclaim Clinical Research	San Diego	California
United States	Artemis Institute for Clinical Research - San Diego	San Diego	California
United States	WR-MCCR	San Diego	California
United States	National Research Institute, A Clinical Research Organization	Santa Ana	California
United States	I Research Savannah	Savannah	Georgia
United States	Seattle Womens	Seattle	Washington
United States	Hillcrest Clinical Research	Simpsonville	South Carolina
United States	Meridian Clinical Research	Sioux City	Iowa
United States	Plains Clinical Research	South West Fargo	North Dakota
United States	Santos Research Center	Tampa	Florida
United States	VICIS Clinical Research, Inc	Tampa	Florida
United States	Alliance For Multispecialty Research	Tempe	Arizona
United States	Cognitive Clinical Trials, LLC	Tempe	Arizona
United States	DM Clinical Research	Tomball	Texas
United States	Clinedge, LLC	Tucson	Arizona
United States	Delricht Research	Tulsa	Oklahoma
United States	Tidewater Integrated Medical Research	Virginia Beach	Virginia
United States	"Medvadis Research Corp, Llc @Boston Paincare Center "	Waltham	Massachusetts
United States	Velocity Clinical Research.- Providence	Warwick	Rhode Island
United States	CIS Research	Wauconda	Illinois
United States	Integrated Clinical Trial SVC	West Des Moines	Iowa
United States	Palm Beach Research	West Palm Beach	Florida
United States	Upstate Clinical Research Associates	Williamsville	New York
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina
United States	PMG Research Inc	Winston-Salem	North Carolina
United States	Conquest Research, LLC	Winter Park	Florida
United States	Tekton Research	Yukon	Oklahoma

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