NCT07646613
Study Evaluating the Efficacy, Safety, and Tolerability of ASY202 (Dihydroergotamine Mesylate [DHE] Inhalation Powder Delivered Via a Multidose Dry Powder Inhaler) for the Acute Treatment of Migraine in Adult Patients
Recruiting
PHASE2Ages 18–65InterventionalTreatmentAspeya, Inc.
~108 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:ASY202Placebo
At a glance
Recruiting sites
1 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients with freedom from headache pain at 2 hours post-dose
Measured over 2 hours Post-Dose
Conditions
Where it's being run
6 sites across 5 statesFlorida2
California1
Nevada1
Tennessee1
Utah1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Able to understand study procedures and provide written informed consent
Male or female, 18-65 years of age at Screening
BMI between 18.5-35 kg/m² at Screening
Documented history of migraine (with or without aura) for ≥1 year, consistent with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)
Female participants must be either:
of non-childbearing potential, or
of childbearing potential using protocol required contraception
Exclusion
Diagnosis of headache conditions other than migraine
History or current diagnosis of coronary artery disease (CAD)
History or current diagnosis of coronary artery vasospasm (including Printz-metal's angina), clinically significant arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation) or peripheral vascular disease, ischemic disease (e.g., Raynaud's syndrome, ischemic bowel syndrome, angina pectoris, myocardial infarction, or documented silent ischemia)
History of percutaneous coronary intervention, cardiac surgery, sepsis or vascular surgery
History or current diagnosis of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, or subarachnoid hemorrhage
Known history or current diagnosis of psychological and/or psychiatric condition that, in the opinion of the Investigator, might interfere with study participation and assessments or participant safety. These conditions may include depression, psychosis, schizophrenia, bipolar disorder, dementia, alcoholism, drug abuse, etc.
Known allergic reactions, hypersensitivity, or contraindications to DHE, other ergot-derived products, or any other excipient in the formulation
Use of strong or moderate CYP3A4 inhibitors within 14 days (or 5 half-lives) or CYP3A4 inducers within 28 days (or 5 half-lives) prior to Randomization
Any clinically significant symptoms or conditions at screening, other than migraine, 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 participant safety
What this trial measures
- Proportion of patients with freedom from headache pain at 2 hours post-dose2 hours Post-Dose
Proportion of patients achieving freedom from headache pain at 2 hours following administration of a single 2.0 mg dose of ASY202 compared with placebo. Headache pain freedom is defined as a reduction from moderate or severe headache intensity (score of 2 or 3 on a 4-point scale) at baseline (time 0) to no headache pain (score of 0 on the same 4-point scale) at 2 hours post-dose.