A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine
Condition: Migraine; Migraine With Aura; Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura; Migraine with Aura
Intervention: Dihydroergotamine; Placebo
Intervention description: Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.; Placebo for STS101
Intervention MeSH terms: Dihydroergotamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1591.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: dihydroergotamine; dihydroergotamine mesylate; migraine

Summary:

      Study STS101-007 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.
    

Eligibility 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)

        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.