Overview

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

Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Satsuma Pharmaceuticals, Inc.
Treatments:
Dihydroergotamine
Criteria
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.