A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine

Overview

Study STS101-003 is a multi-center, multiple dose (PRN), open-label, 12-month study to evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine.

Full Title of Study: “An Open-Label, 12-Month Study to Evaluate the Safety and Tolerability 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: None (Open Label)
  • Study Primary Completion Date: October 2021

Detailed Description

The ASCEND trial is a multi-center, multiple dose (PRN), open-label, 12-month study to evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine.

Interventions

  • Drug: Dihydroergotamine
    • Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
    • Time Frame: Up to 12 months
    • Incidence of adverse events, incidence of abnormal physical examination findings, abnormal 12-lead ECG readings and incidence of nasal symptoms.

Secondary Measures

  • Pain Freedom
    • Time Frame: Up to 48 hours post-dosing
    • Proportion of subjects free from headache pain (defined as moderate or severe headache pain becoming none on a 4-point scale)
  • Freedom From Most-Bothersome Symptom
    • Time Frame: Up to 48 hours post-dosing
    • Proportion of subjects free from most bothersome symptom (MBS) among photophobia, phonophobia and nausea

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)

Key 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.
  • Overall Contact(s)
    • Clinical Trial Manager, 6508370799, clin.inquiries@satsumarx.com

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