A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine
(EMERGE Trial)
Recruiting in Palo Alto (17 mi)
+116 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Satsuma Pharmaceuticals, Inc.
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
Study STS101-002 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
Research Team
DA
Detlef Albrecht, MD
Principal Investigator
Satsuma Pharmaceuticals, Inc.
Eligibility Criteria
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)
Treatment Details
Interventions
- Dihydroergotamine (Ergot Alkaloid)
- Placebos (Drug)
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: STS101 Low DoseExperimental Treatment1 Intervention
STS101 (dihydroergotamine nasal powder), low dose
Group II: STS101 High DoseExperimental Treatment1 Intervention
STS101 (dihydroergotamine nasal powder), high dose
Group III: STS101 PlaceboPlacebo Group1 Intervention
STS101 Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Satsuma Pharmaceuticals, Inc.
Lead Sponsor
Trials
5
Recruited
3,400+