Clinical trial NCT03901482: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine
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
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: 2019-04-03
Enrollment: 1201
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 STS101-002 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).

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)

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