A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine
NCT ID: NCT04406649
Last Updated: 2023-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
482 participants
INTERVENTIONAL
2020-09-14
2023-01-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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STS101
STS101 (dihydroergotamine nasal powder)
Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Interventions
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Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Satsuma Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Detlef Albrecht, MD
Role: STUDY_CHAIR
Satsuma Pharmaceuticals, Inc.
Locations
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WR-PRI
Encino, California, United States
Collaborative Neuroscience
Long Beach, California, United States
WR-PRI
Los Alamitos, California, United States
Downtown LA Research
Los Angeles, California, United States
Clinical Research Institute
Los Angeles, California, United States
WR-PRI
Newport Beach, California, United States
Hillcrest Medical Research
DeLand, Florida, United States
MD Clinical
Hallandale, Florida, United States
Multi-Specialty Research Associates
Lake City, Florida, United States
ClinCloud
Maitland, Florida, United States
Biotech Pharmaceuticals
Miami, Florida, United States
Behavioral Clinical Research
Miami Lakes, Florida, United States
CNS Health Care - Orlando
Orlando, Florida, United States
Complete Health Research
Ormond Beach, Florida, United States
Infinity Clinical Research
Sunrise, Florida, United States
Santos Research Center, Corp
Tampa, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Clinical Research CF
Winter Haven, Florida, United States
Advanced Clinical Research
Meridian, Idaho, United States
Integrated Clinical Trial Services, Inc
West Des Moines, Iowa, United States
Delricht Research
Prairieville, Louisiana, United States
Medvadis Research at Boston PainCare Center
Waltham, Massachusetts, United States
Healthcare Research Network
Hazelwood, Missouri, United States
Clinvest Research
Springfield, Missouri, United States
Montana Medical Research
Missoula, Montana, United States
Wake Research - Clinical Research Center of Nevada
Las Vegas, Nevada, United States
Dartmouth-Hitchcock Neurology Headache Clinic
Lebanon, New Hampshire, United States
Hassman Research Institute
Berlin, New Jersey, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States
SPRI Clinical Research
Brooklyn, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
PharmQuest
Greensboro, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Rapid Medical Research
Cleveland, Ohio, United States
Neurology Diagnosis
Dayton, Ohio, United States
Delricht Research
Tulsa, Oklahoma, United States
Thomas Jefferson University/Jefferson Headache Center
Philadelphia, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
CNS Healthcare - Memphis
Memphis, Tennessee, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Georgetown University Hospital, Department of Neurology
McLean, Virginia, United States
Countries
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References
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Tepper SJ, Albrecht D, Ailani J, Kirby L, Strom S, Rapoport AM. Long-Term (12-Month) Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine: Data from the Phase 3 Open-Label ASCEND Study. CNS Drugs. 2024 Dec;38(12):1017-1027. doi: 10.1007/s40263-024-01118-8. Epub 2024 Oct 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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STS101-003
Identifier Type: -
Identifier Source: org_study_id
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