Status:
COMPLETED
A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine
Lead Sponsor:
Satsuma Pharmaceuticals, Inc.
Conditions:
Migraine
Migraine With Aura
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 migrain...
Detailed Description
The ASCEND trial 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 migrain...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
September 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2023
Estimated Enrollment :
482 Patients enrolled
Trial Details
Trial ID
NCT04406649
Start Date
September 14 2020
End Date
January 16 2023
Last Update
July 3 2023
Active Locations (44)
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1
WR-PRI
Encino, California, United States, 91316
2
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Long Beach, California, United States, 90806
3
WR-PRI
Los Alamitos, California, United States, 90720
4
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Los Angeles, California, United States, 90017