A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 1,591
- Locations
- 115
- Primary Endpoint
- Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose
Study Overview
Brief 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.
Detailed Description
Study STS101-007 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
STS101
STS101 (dihydroergotamine nasal powder)
Intervention: Dihydroergotamine (Drug)
STS101 Placebo
STS101 Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose
Time Frame: 2 Hours Post-Dose
The subject's rating was documented on a four-point scale from no pain (= 0), mild pain (= 1), moderate pain (= 2) to severe pain (= 3). Pain freedom means the pain went from moderate (2) or severe (3) to no pain (0).
Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose
Time Frame: 2 Hours Post-Dose
Subjects were prompted to document the presence of 3 symptoms (photophobia, phonophobia, and nausea) immediately before study drug administration and during the treated migraine attack.
Secondary Outcomes
- Percentage of Subjects With Relief From Migraine Headache Pain at 2 Hours Post Dose(2 Hours Post Dose)