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

Phase 3

Completed

Conditions: Migraine
Migraine With Aura
Migraine Without Aura

Interventions: Drug: Placebos
Drug: Dihydroergotamine

Registration Number: NCT03901482

Lead Sponsor: Satsuma Pharmaceuticals, Inc.

Brief Summary: 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

Detailed Description: The EMERGE trial is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study in subjects with acute migraine (ages 18 to 65 years).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1201

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)

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STS101 Placebo	Placebos	STS101 Placebo
STS101 High Dose	Dihydroergotamine	STS101 (dihydroergotamine nasal powder), high dose
STS101 Low Dose	Dihydroergotamine	STS101 (dihydroergotamine nasal powder), low dose

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose	2 Hours Post-Dose	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.
Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose	2 Hours Post-Dose	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).

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose	2 Hours Post Dose	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 relief means the pain went from moderate (2) or severe (3) to mild pain (1) or no pain (0).

Trial Locations

Locations (114): Accel Clinical - Birmingham
🇺🇸
Birmingham, Alabama, United States
Alabama Clinical Therapeutics
🇺🇸
Birmingham, Alabama, United States
Alea Research
🇺🇸
Phoenix, Arizona, United States
Elite Clinical Studies
🇺🇸
Phoenix, Arizona, United States
Arizona Research Center
🇺🇸
Phoenix, Arizona, United States
Tucson Neuroscience Research
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Tucson, Arizona, United States
The Research Center of Southern California
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Carlsbad, California, United States
Med Center Medical Clinic
🇺🇸
Carmichael, California, United States
WR-PRI
🇺🇸
Newport Beach, California, United States
Marvel Clinical Research
🇺🇸
Huntington Beach, California, United States
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Accel Clinical - Birmingham
🇺🇸Birmingham, Alabama, United States