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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.

Tracking Information
First Submitted Date  ICMJE April 2, 2019
First Posted Date  ICMJE April 3, 2019
Last Update Posted Date August 19, 2019
Actual Study Start Date  ICMJE June 24, 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03901482 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Migraine
  • Migraine With Aura
  • Migraine Without Aura
Intervention  ICMJE
  • Drug: Dihydroergotamine
    Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
    Other Name: Dihydroergotamine Mesylate
  • Drug: Placebos
    Placebo for STS101
    Other Name: STS101 Placebo
Study Arms  ICMJE
  • Experimental: STS101 Low Dose
    STS101 (dihydroergotamine nasal powder), low dose
    Intervention: Drug: Dihydroergotamine
  • Experimental: STS101 High Dose
    STS101 (dihydroergotamine nasal powder), high dose
    Intervention: Drug: Dihydroergotamine
  • Placebo Comparator: STS101 Placebo
    STS101 Placebo
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2019)
1140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trial Manager 9193148386 clin.inquiries@satsumarx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03901482
Other Study ID Numbers  ICMJE STS101-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Satsuma Pharmaceuticals, Inc.
Study Sponsor  ICMJE Satsuma Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Detlef Albrecht, MD Satsuma Pharmaceuticals, Inc.
PRS Account Satsuma Pharmaceuticals, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP