Clinical trial NCT04940390: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Migraine With Aura
Migraine Without Aura
Keywords: dihydroergotamine
dihydroergotamine mesylate
migraine
Lead sponsor: Satsuma Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-25
Enrollment: 1591
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose
timeFrame: 2 Hours Post-Dose
measure: Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose
timeFrame: 2 Hours Post-Dose
Secondary outcomes:
measure: Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose
timeFrame: 2 Hours Post Dose
Other outcomes:
Locations:
city: Chandler
country: United States
facility: MD First Research
state: Arizona
city: Phoenix
country: United States
facility: Elite Clinical Studies
state: Arizona
city: Tempe
country: United States
facility: Alliance For Multispecialty Research
state: Arizona
city: Tempe
country: United States
facility: Cognitive Clinical Trials, LLC
state: Arizona
city: Tucson
country: United States
facility: Clinedge, LLC
state: Arizona
city: Little Rock
country: United States
facility: ERG Clinical
state: Arkansas
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Encino
country: United States
facility: Wr-Pri, Llc
state: California
city: Fresno
country: United States
facility: Neuro-Pain Medical Center Ince
state: California
city: La Mesa
country: United States
facility: Estudy Site - La Mesa
state: California
city: Los Alamitos
country: United States
facility: Wr-Pri Llc
state: California
city: Los Angeles
country: United States
facility: Downtown LA Research Center
state: California
city: Los Angeles
country: United States
facility: Clinical Research Institute
state: California
city: Newport Beach
country: United States
facility: Wr-Pri Llc
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research - San Diego
state: California
city: San Diego
country: United States
facility: WR-MCCR
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research
state: California
city: Santa Ana
country: United States
facility: National Research Institute, A Clinical Research Organization
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center, Inc
state: Colorado
city: Cromwell
country: United States
facility: Clinedge, LLC
state: Connecticut
city: Boca Raton
country: United States
facility: Neurology Offices of South Florida
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallendale Beach
state: Florida
city: Hollywood
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Elite Research Network, LLC a Florida LLC
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Jupiter
country: United States
facility: Elite Research Network LLC a Florida LLC
state: Florida
city: Lake City
country: United States
facility: Multi-Specialty Research Associates
state: Florida
city: Maitland
country: United States
facility: Clinicloud
state: Florida
city: Miami
country: United States
facility: Next Phase Research
state: Florida
city: Miami
country: United States
facility: Applemed Research Group
state: Florida
city: Miami
country: United States
facility: Biotech Pharmaceuticals Group LLC
state: Florida
city: Miami
country: United States
facility: Novel Clinical Research Center LLC
state: Florida
city: Miami
country: United States
facility: Floridian Research
state: Florida
city: North Miami
country: United States
facility: Behavioral Clinical Research
state: Florida
city: Orange City
country: United States
facility: Accel-Orange City
state: Florida
city: Orlando
country: United States
facility: CNS Health Care Orlando
state: Florida
city: Ormond Beach
country: United States
facility: Complete Health Research
state: Florida
city: Oviedo
country: United States
facility: Oveido Medical Research
state: Florida
city: Tampa
country: United States
facility: Santos Research Center
state: Florida
city: Tampa
country: United States
facility: VICIS Clinical Research, Inc
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research
state: Florida
city: Winter Park
country: United States
facility: Conquest Research, LLC
state: Florida
city: Atlanta
country: United States
facility: Delricht
state: Georgia
city: Decatur
country: United States
facility: I-Research Atlanta
state: Georgia
city: Johns Creek
country: United States
facility: Alpha Clinical Research Georgia
state: Georgia
city: Marietta
country: United States
facility: Clin-Edge, LLC
state: Georgia
city: Savannah
country: United States
facility: I Research Savannah
state: Georgia
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Wauconda
country: United States
facility: CIS Research
state: Illinois
city: Evansville
country: United States
facility: Medisphere Medical Research Center
state: Indiana
city: Ames
country: United States
facility: PMG Research Inc
state: Iowa
city: Sioux City
country: United States
facility: Meridian Clinical Research
state: Iowa
city: West Des Moines
country: United States
facility: Integrated Clinical Trial SVC
state: Iowa
city: Lexington
country: United States
facility: Alliance For Multispecialty Research
state: Kentucky
city: Louisville
country: United States
facility: Louisville Metabolic & Atherosclerosis Research Center
state: Kentucky
city: Baton Rouge
country: United States
facility: Delricht Research
state: Louisiana
city: Chalmette
country: United States
facility: Crescent City Headache and Neurology
state: Louisiana
city: Covington
country: United States
facility: Delricht
state: Louisiana
city: New Orleans
country: United States
facility: Alliance for Multispecialty Research
state: Louisiana
city: New Orleans
country: United States
facility: Delricht-New Orleans
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: New Bedford
country: United States
facility: BTC of New Bedford
state: Massachusetts
city: North Dartmouth
country: United States
facility: Northeast Medical Research Associates
state: Massachusetts
city: Waltham
country: United States
facility: "Medvadis Research Corp, Llc @Boston Paincare Center "
state: Massachusetts
city: Ann Arbor
country: United States
facility: MHNI
state: Michigan
city: Burnsville
country: United States
facility: Minneapolis Clinic of Neurology
state: Minnesota
city: Gulfport
country: United States
facility: Delricht
state: Mississippi
city: Kansas City
country: United States
facility: Alliance for Multispecialty Research
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research, Inc
state: Montana
city: Elkhorn
country: United States
facility: Skyline Medical Center, PC CCT Research
state: Nebraska
city: Fremont
country: United States
facility: Cognitive Clinical Trials, LLC
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research, Inc
state: Nebraska
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: Las Vegas
country: United States
facility: Wake Research-Clinical Research Center of Nevada LLC
state: Nevada
city: North Las Vegas
country: United States
facility: Clinedge LLC
state: Nevada
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: Brooklyn
country: United States
facility: Integrative Clinical Trials
state: New York
city: Brooklyn
country: United States
facility: SPRI Clinical Trials, LLC
state: New York
city: Commack
country: United States
facility: North Suffolk Neurology
state: New York
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: Manlius
country: United States
facility: Central New York Clinical Research
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates
state: New York
city: Charlotte
country: United States
facility: PMG Research of Charlotte
state: North Carolina
city: Charlotte
country: United States
facility: Onsite Clinical
state: North Carolina
city: Greensboro
country: United States
facility: Headache Wellness Center - Greensboro
state: North Carolina
city: Greensboro
country: United States
facility: Pharmquest, LLC
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research, Inc
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research Inc
state: North Carolina
city: South West Fargo
country: United States
facility: Plains Clinical Research
state: North Dakota
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research
state: Ohio
city: Dublin
country: United States
facility: Aventiv Research, Inc
state: Ohio
city: Edmond
country: United States
facility: OK Clinical Research
state: Oklahoma
city: Norman
country: United States
facility: Elite Research Network, LLC a Florida LLC
state: Oklahoma
city: Oklahoma City
country: United States
facility: Hightower Clinical
state: Oklahoma
city: Tulsa
country: United States
facility: Delricht Research
state: Oklahoma
city: Yukon
country: United States
facility: Tekton Research
state: Oklahoma
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Lincoln
country: United States
facility: Ocean State Clinical Research Partners
state: Rhode Island
city: Warwick
country: United States
facility: Velocity Clinical Research.- Providence
state: Rhode Island
city: Charleston
country: United States
facility: Clinedge LLC - Clinical Trials SSC
state: South Carolina
city: Greenville
country: United States
facility: Tribe CR
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center Inc
state: South Carolina
city: Simpsonville
country: United States
facility: Hillcrest Clinical Research
state: South Carolina
city: Bristol
country: United States
facility: Internal Medicine and Pediatric Associates of Bristol, PC
state: Tennessee
city: Knoxville
country: United States
facility: New Phase Research & Development
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc
state: Tennessee
city: Austin
country: United States
facility: Future Search Trials of Neurology
state: Texas
city: Austin
country: United States
facility: Premier Family Physicians
state: Texas
city: Bryan
country: United States
facility: Discoveresearch
state: Texas
city: Dallas
country: United States
facility: Future Search Trials of Dallas, LP
state: Texas
city: Dallas
country: United States
facility: Cedar Health Research, LLC
state: Texas
city: Frisco
country: United States
facility: North Texas Institute of Neurology
state: Texas
city: Lewisville
country: United States
facility: Epic Clinical Research
state: Texas
city: Magnolia
country: United States
facility: DM Clinical Research
state: Texas
city: Plano
country: United States
facility: Village Health Partners
state: Texas
city: San Antonio
country: United States
facility: Sun Research
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Norfolk
country: United States
facility: Alliance For Multispecialty Research
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Integrated Medical Research
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Seattle Womens
state: Washington
Study officials:
affiliation: Satsuma Pharmaceuticals, Inc.
name: Detlef Albrecht, MD
role: STUDY_CHAIR
References: