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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 : Recruiting
First Posted : April 3, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Migraine Migraine With Aura Migraine Without Aura Drug: Dihydroergotamine Drug: Placebos Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1140 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
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 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




Primary Outcome Measures :
  1. Pain Freedom at 2 Hours [ Time Frame: 2 Hours Post-Dose ]
    Proportion of subjects free from headache pain at 2 hours post dose

  2. 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


Secondary Outcome Measures :
  1. 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

  2. Rescue Medication Usage [ Time Frame: Up to 48 hours post-dosing ]
    Proportion of subjects who use rescue medication

  3. 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)



Information from the National Library of Medicine

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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
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)

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Clinical Trial Manager 9193148386 clin.inquiries@satsumarx.com

  Show 52 Study Locations
Sponsors and Collaborators
Satsuma Pharmaceuticals, Inc.
Investigators
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Study Chair: Detlef Albrecht, MD Satsuma Pharmaceuticals, Inc.

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Responsible Party: Satsuma Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03901482     History of Changes
Other Study ID Numbers: STS101-002
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Satsuma Pharmaceuticals, Inc.:
dihydroergotamine
dihydroergotamine mesylate
migraine
Additional relevant MeSH terms:
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Migraine Disorders
Migraine with Aura
Migraine without 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