A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine
ASCEND
An Open-Label, 12-Month Study to Evaluate the Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine
1 other identifier
interventional
482
1 country
44
Brief Summary
Study STS101-003 is a multi-center, multiple dose (PRN), open-label, 12-month study to evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2020
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2020
CompletedFirst Posted
Study publicly available on registry
May 28, 2020
CompletedStudy Start
First participant enrolled
September 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2023
CompletedResults Posted
Study results publicly available
July 3, 2023
CompletedJuly 3, 2023
June 1, 2023
2.3 years
May 20, 2020
June 12, 2023
June 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Attacks With Sustained Freedom From Headache Pain 2-48 Hours (Modified Intent to Treat Population)
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).
At Month 12 of Study Medication Dosing
Percentage of Participants With Attacks With Sustained Freedom From Most Bothersome Symptom 2-48 Hours (Modified Intent to Treat Population)
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.
At Month 12 of Study Drug Administration
Study Arms (1)
STS101
EXPERIMENTALSTS101 (dihydroergotamine nasal powder)
Interventions
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
WR-PRI
Encino, California, 91316, United States
Collaborative Neuroscience
Long Beach, California, 90806, United States
WR-PRI
Los Alamitos, California, 90720, United States
Downtown LA Research
Los Angeles, California, 90017, United States
Clinical Research Institute
Los Angeles, California, 90048, United States
WR-PRI
Newport Beach, California, 92660, United States
Hillcrest Medical Research
DeLand, Florida, 32720, United States
MD Clinical
Hallandale, Florida, 33009, United States
Multi-Specialty Research Associates
Lake City, Florida, 32055, United States
ClinCloud
Maitland, Florida, 32751, United States
Biotech Pharmaceuticals
Miami, Florida, 33155, United States
Behavioral Clinical Research
Miami Lakes, Florida, 33061, United States
CNS Health Care - Orlando
Orlando, Florida, 32801, United States
Complete Health Research
Ormond Beach, Florida, 32174, United States
Infinity Clinical Research
Sunrise, Florida, 33351, United States
Santos Research Center, Corp
Tampa, Florida, 33615, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Clinical Research CF
Winter Haven, Florida, 33880, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
Integrated Clinical Trial Services, Inc
West Des Moines, Iowa, 50265, United States
Delricht Research
Prairieville, Louisiana, 70769, United States
Medvadis Research at Boston PainCare Center
Waltham, Massachusetts, 02451, United States
Healthcare Research Network
Hazelwood, Missouri, 63042, United States
Clinvest Research
Springfield, Missouri, 65810, United States
Montana Medical Research
Missoula, Montana, 59808, United States
Wake Research - Clinical Research Center of Nevada
Las Vegas, Nevada, 89118, United States
Dartmouth-Hitchcock Neurology Headache Clinic
Lebanon, New Hampshire, 03766, United States
Hassman Research Institute
Berlin, New Jersey, 08009, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102, United States
SPRI Clinical Research
Brooklyn, New York, 11235, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
PharmQuest
Greensboro, North Carolina, 27408, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Rapid Medical Research
Cleveland, Ohio, 44122, United States
Neurology Diagnosis
Dayton, Ohio, 45459, United States
Delricht Research
Tulsa, Oklahoma, 74133, United States
Thomas Jefferson University/Jefferson Headache Center
Philadelphia, Pennsylvania, 19107, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
CNS Healthcare - Memphis
Memphis, Tennessee, 38119, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
DM Clinical Research
Tomball, Texas, 77375, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Georgetown University Hospital, Department of Neurology
McLean, Virginia, 22101, United States
Related Publications (1)
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.
PMID: 39373843DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President of Regulatory Affairs and Quality
- Organization
- Satsuma Pharmaceuticals, Inc.
Study Officials
- STUDY CHAIR
Detlef Albrecht, MD
Satsuma Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2020
First Posted
May 28, 2020
Study Start
September 14, 2020
Primary Completion
January 16, 2023
Study Completion
January 16, 2023
Last Updated
July 3, 2023
Results First Posted
July 3, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share