A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine (EMERGE)
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ClinicalTrials.gov Identifier: NCT03901482 |
Recruitment Status :
Completed
First Posted : April 3, 2019
Last Update Posted : September 14, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Migraine Migraine With Aura Migraine Without Aura | Drug: Dihydroergotamine Drug: Placebos | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1201 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | EMERGE: 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 |
Actual Study Start Date : | June 24, 2019 |
Actual Primary Completion Date : | July 31, 2020 |
Actual Study Completion Date : | August 13, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: STS101 Low Dose
STS101 (dihydroergotamine nasal powder), low dose
|
Drug: Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Other Name: Dihydroergotamine Mesylate |
Experimental: STS101 High Dose
STS101 (dihydroergotamine nasal powder), high dose
|
Drug: Dihydroergotamine
Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Other Name: Dihydroergotamine Mesylate |
Placebo Comparator: STS101 Placebo
STS101 Placebo
|
Drug: Placebos
Placebo for STS101
Other Name: STS101 Placebo |
- Pain Freedom at 2 Hours [ Time Frame: 2 Hours Post-Dose ]Proportion of subjects free from headache pain at 2 hours post dose
- Freedom From Most-Bothersome Symptom at 2 Hours [ Time Frame: 2 Hours Post-Dose ]Proportion of subjects free from most bothersome symptom (MBS) among photophobia, phonophobia and nausea at 2 hours post dose
- Sustained Pain-Free [ Time Frame: Up to 48 hours post-dosing ]Proportion of subjects free from headache pain at 2 hours post dose and remaining headache free at 24 hours post dose with no use of rescue medication and no relapse of any headache pain
- Rescue Medication Usage [ Time Frame: Up to 48 hours post-dosing ]Proportion of subjects who use rescue medication
- Pain Relapse [ Time Frame: Up to 48 hours post-dosing ]Proportion of subjects with headache relapse (defined as the return of headache of any severity within 24 hours post dosing of the investigational drug, when the subject was pain-free at 2 hours after investigational drug administration)

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901482

Study Chair: | Detlef Albrecht, MD | Satsuma Pharmaceuticals, Inc. |
Responsible Party: | Satsuma Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT03901482 |
Other Study ID Numbers: |
STS101-002 |
First Posted: | April 3, 2019 Key Record Dates |
Last Update Posted: | September 14, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
dihydroergotamine dihydroergotamine mesylate migraine |
Migraine Disorders Migraine without Aura Migraine with Aura Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Dihydroergotamine Vasoconstrictor Agents |
Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |