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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: June 2020

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).

Interventions

  • Drug: Dihydroergotamine
    • Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
  • Drug: Placebos
    • Placebo for STS101

Arms, Groups and Cohorts

  • Experimental: STS101 Low Dose
    • STS101 (dihydroergotamine nasal powder), low dose
  • Experimental: STS101 High Dose
    • STS101 (dihydroergotamine nasal powder), high dose
  • Placebo Comparator: STS101 Placebo
    • STS101 Placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Satsuma Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Detlef Albrecht, MD, Study Chair, Satsuma Pharmaceuticals, Inc.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.