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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04940390
Other study ID # STS101-007
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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