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

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified October 2023 by Satsuma Pharmaceuticals, Inc.
Sponsor
Satsuma Pharmaceuticals, Inc.
Information Provided by (Responsible Party)
Satsuma Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
NCT04940390
Other Study ID Numbers:
STS101-007
First Submitted
June 16, 2021
First Posted
June 24, 2021
Results First Posted
June 11, 2023
Last Update Posted
November 26, 2023
Last Verified
October 2023

ClinicalTrials.gov processed this data on November 2023. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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).

Condition or DiseaseIntervention/Treatment
MigraineMigraine With AuraMigraine Without Aura
Drug: DihydroergotamineDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment1591 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA 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 Start DateJune 29, 2021
Actual Primary Completion DateOctober 12, 2022
Actual Study Completion DateOctober 25, 2022

Groups and Cohorts

Group/CohortIntervention/Treatment
STS101
STS101 (dihydroergotamine nasal powder)
Drug: Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
STS101 Placebo
STS101 Placebo
Drug: Placebo
Placebo for STS101

Outcome Measures

Primary Outcome Measures
  1. 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. 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.
Secondary Outcome Measures
  1. 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).

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsSatsuma Pharmaceuticals, Inc.
Locations
MD First Research | Chandler Arizona, United States, 85286Elite Clinical Studies | Phoenix Arizona, United States, 85018Alliance For Multispecialty Research | Tempe Arizona, United States, 85283Cognitive Clinical Trials, LLC | Tempe Arizona, United States, 85283Clinedge, LLC | Tucson Arizona, United States, 85704ERG Clinical | Little Rock Arkansas, United States, 72211Hope Clinical Research | Canoga Park California, United States, 91303Wr-Pri, Llc | Encino California, United States, 91316Neuro-Pain Medical Center Ince | Fresno California, United States, 93710Estudy Site - La Mesa | La Mesa California, United States, 91942Wr-Pri Llc | Los Alamitos California, United States, 90720Downtown LA Research Center | Los Angeles California, United States, 90017Clinical Research Institute | Los Angeles California, United States, 90048Wr-Pri Llc | Newport Beach California, United States, 92660Artemis Institute for Clinical Research - San Diego | San Diego California, United States, 92103WR-MCCR | San Diego California, United States, 92108Acclaim Clinical Research | San Diego California, United States, 92120National Research Institute, A Clinical Research Organization | Santa Ana California, United States, 92704Alpine Clinical Research Center, Inc | Boulder Colorado, United States, 80301Clinedge, LLC | Cromwell Connecticut, United States, 06416Neurology Offices of South Florida | Boca Raton Florida, United States, 33428Velocity Clinical Research, Hallendale Beach | Hallandale Florida, United States, 33009Infinity Clinical Research, LLC | Hollywood Florida, United States, 33024Elite Research Network, LLC a Florida LLC | Jacksonville Florida, United States, 32216Clinical Neuroscience Solutions, Inc | Jacksonville Florida, United States, 32256Elite Research Network LLC a Florida LLC | Jupiter Florida, United States, 33458Multi-Specialty Research Associates | Lake City Florida, United States, 32055Clinicloud | Maitland Florida, United States, 32751Next Phase Research | Miami Florida, United States, 33144Applemed Research Group | Miami Florida, United States, 33155Biotech Pharmaceuticals Group LLC | Miami Florida, United States, 33155Novel Clinical Research Center LLC | Miami Florida, United States, 33173Floridian Research | Miami Florida, United States, 33179Behavioral Clinical Research | North Miami Florida, United States, 33161Accel-Orange City | Orange City Florida, United States, 32763CNS Health Care Orlando | Orlando Florida, United States, 32801Complete Health Research | Ormond Beach Florida, United States, 32174Oveido Medical Research | Oviedo Florida, United States, 32765Santos Research Center | Tampa Florida, United States, 33603VICIS Clinical Research, Inc | Tampa Florida, United States, 33615Palm Beach Research | West Palm Beach Florida, United States, 33409Conquest Research, LLC | Winter Park Florida, United States, 32789Delricht | Atlanta Georgia, United States, 30329I-Research Atlanta | Decatur Georgia, United States, 30030Alpha Clinical Research Georgia | Johns Creek Georgia, United States, 30022Clin-Edge, LLC | Marietta Georgia, United States, 30060I Research Savannah | Savannah Georgia, United States, 31405Advanced Clinical Research | Meridian Idaho, United States, 83642CIS Research | Wauconda Illinois, United States, 60084Medisphere Medical Research Center | Evansville Indiana, United States, 47714PMG Research Inc | Ames Iowa, United States, 50010Meridian Clinical Research | Sioux City Iowa, United States, 51106Integrated Clinical Trial SVC | West Des Moines Iowa, United States, 50265Alliance For Multispecialty Research | Lexington Kentucky, United States, 40509Louisville Metabolic & Atherosclerosis Research Center | Louisville Kentucky, United States, 40213Delricht Research | Baton Rouge Louisiana, United States, 70817Crescent City Headache and Neurology | Chalmette Louisiana, United States, 70043Delricht | Covington Louisiana, United States, 70433Alliance for Multispecialty Research | New Orleans Louisiana, United States, 70119Delricht-New Orleans | New Orleans Louisiana, United States, 70124Boston Clinical Trials | Boston Massachusetts, United States, 02131BTC of New Bedford | New Bedford Massachusetts, United States, 02740Northeast Medical Research Associates | North Dartmouth Massachusetts, United States, 02747"Medvadis Research Corp, Llc @Boston Paincare Center " | Waltham Massachusetts, United States, 02451MHNI | Ann Arbor Michigan, United States, 48104Minneapolis Clinic of Neurology | Burnsville Minnesota, United States, 55337Delricht | Gulfport Mississippi, United States, 39503Alliance for Multispecialty Research | Kansas City Missouri, United States, 64114Montana Medical Research, Inc | Missoula Montana, United States, 59808Skyline Medical Center, PC CCT Research | Elkhorn Nebraska, United States, 68022Cognitive Clinical Trials, LLC | Fremont Nebraska, United States, 68025Quality Clinical Research, Inc | Omaha Nebraska, United States, 68114Excel Clinical Research | Las Vegas Nevada, United States, 89109Wake Research-Clinical Research Center of Nevada LLC | Las Vegas Nevada, United States, 89118Clinedge LLC | North Las Vegas Nevada, United States, 89030Albuquerque Clinical Trials | Albuquerque New Mexico, United States, 87102Integrative Clinical Trials | Brooklyn New York, United States, 11229SPRI Clinical Trials, LLC | Brooklyn New York, United States, 11235North Suffolk Neurology | Commack New York, United States, 11725Drug Trials America | Hartsdale New York, United States, 10530Central New York Clinical Research | Manlius New York, United States, 13104Upstate Clinical Research Associates | Williamsville New York, United States, 14221PMG Research of Charlotte | Charlotte North Carolina, United States, 28209Onsite Clinical | Charlotte North Carolina, United States, 28277Headache Wellness Center - Greensboro | Greensboro North Carolina, United States, 27405Pharmquest, LLC | Greensboro North Carolina, United States, 27408Peters Medical Research | High Point North Carolina, United States, 27262North Carolina Clinical Research | Raleigh North Carolina, United States, 27607PMG Research, Inc | Raleigh North Carolina, United States, 27609PMG Research of Wilmington, LLC | Wilmington North Carolina, United States, 28401PMG Research Inc | Winston-Salem North Carolina, United States, 27103Plains Clinical Research | South West Fargo North Dakota, United States, 58104CTI Clinical Research Center | Cincinnati Ohio, United States, 45212Aventiv Research | Columbus Ohio, United States, 43213Aventiv Research, Inc | Dublin Ohio, United States, 43016OK Clinical Research | Edmond Oklahoma, United States, 73034Elite Research Network, LLC a Florida LLC | Norman Oklahoma, United States, 73072Hightower Clinical | Oklahoma City Oklahoma, United States, 73134Delricht Research | Tulsa Oklahoma, United States, 74133Tekton Research | Yukon Oklahoma, United States, 73099Suburban Research Associates | Media Pennsylvania, United States, 19063Ocean State Clinical Research Partners | Lincoln Rhode Island, United States, 02865Velocity Clinical Research.- Providence | Warwick Rhode Island, United States, 02886Clinedge LLC - Clinical Trials SSC | Charleston South Carolina, United States, 29406Tribe CR | Greenville South Carolina, United States, 29607Coastal Carolina Research Center Inc | North Charleston South Carolina, United States, 29405Hillcrest Clinical Research | Simpsonville South Carolina, United States, 29681Internal Medicine and Pediatric Associates of Bristol, PC | Bristol Tennessee, United States, 37620New Phase Research & Development | Knoxville Tennessee, United States, 37909Clinical Research Associates, Inc | Nashville Tennessee, United States, 37203Future Search Trials of Neurology | Austin Texas, United States, 78731Premier Family Physicians | Austin Texas, United States, 78735Discoveresearch | Bryan Texas, United States, 77802Future Search Trials of Dallas, LP | Dallas Texas, United States, 75231Cedar Health Research, LLC | Dallas Texas, United States, 75251North Texas Institute of Neurology | Frisco Texas, United States, 75034Epic Clinical Research | Lewisville Texas, United States, 75057DM Clinical Research | Magnolia Texas, United States, 77355Village Health Partners | Plano Texas, United States, 75024Sun Research | San Antonio Texas, United States, 78215DM Clinical Research | Tomball Texas, United States, 77375Advanced Research Institute | Ogden Utah, United States, 84405Charlottesville Medical Research | Charlottesville Virginia, United States, 22911Alliance For Multispecialty Research | Norfolk Virginia, United States, 23502Tidewater Integrated Medical Research | Virginia Beach Virginia, United States, 23454Northwest Clinical Research Center | Bellevue Washington, United States, 98007Seattle Womens | Seattle Washington, United States, 98105
Investigators
Study Chair: Detlef Albrecht, MD, Satsuma Pharmaceuticals, Inc.
Study Documents (Full Text)
Documents provided by Satsuma Pharmaceuticals, Inc.: Study Protocol  May 19, 2021Documents provided by Satsuma Pharmaceuticals, Inc.: Statistical Analysis Plan  October 16, 2022