Ireland
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Recruiting Phase 2

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

NCT07646613 · tracked via the Priya Life Science USA tracker
Sponsor
Aspeya, Inc
Phase
Phase 2
Started
2026-05-19
Last updated
2026-10-09

Condition(s) studied

Migraine

Investigational drug(s) / intervention(s)

ASY202Placebo

ASY202: ASY202 is a pre-metered drug-device combination product containing a dry-powder formulation of dihydroergotamine (DHE) intended for oral inhalation, delivered via a dry powder inhaler (DPI).

Placebo: Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.

Study summary

This study is testing an investigational inhaled migraine medication to see how well it works, how safe it is, and how well people tolerate it. Adults with migraine will receive both the study medication (ASY202) and a placebo (inactive treatment) at different times during the study. Neither participants nor study staff will know which treatment is given at the time. The medication is taken using a handheld dry powder inhaler to treat migraine attacks when they occur.

Following screening, eligible participants will be enrolled and randomized to one of two treatments sequences i.e. one treatment sequence will receive ASY202 in treatment period 1 followed by placebo in treatment period 2 and other treatment sequence will receive placebo in treatment period 1 followed by ASY202 in treatment period 2.

The study lasts about 16 weeks and includes a screening period, two treatment periods (with a minimum of 7 days washout period between the treatment periods), and a safety follow-up visit.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

  • Proportion of patients with freedom from headache pain at 2 hours post-dose — 2 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.

Trial sites (20)

FacilityCityRegionStatus
Arizona Research Center Phoenix Arizona Recruiting
Synergy San Diego Lemon Grove California Recruiting
Sunwise Clinical Research, Llc Walnut Creek California Recruiting
New England Institute for Clinical Research Stamford Connecticut Recruiting
Chase Medical Research Waterbury Connecticut Recruiting
Clinical Neuroscineces Solutions - Orlando Orlando Florida Recruiting
Clinical Neuroscineces Solutions Orlando Florida Recruiting
Conquest Research Atlanta Georgia Recruiting
Boston Clinical Trials Roslindale Massachusetts Recruiting
Mass. Institute of Clinical Research Westborough Massachusetts Recruiting
StudyMetrix Research City of Saint Peters Missouri Recruiting
M3 Wake Research - Las Vegas Rainbow Las Vegas Nevada Recruiting
CenExel Marlton NJ Marlton New Jersey Recruiting
SPRI Clinical Trials Brooklyn New York Recruiting
M3 Wake Research Raleigh North Carolina Recruiting
CNS Healthcare Memphis Tennessee Recruiting
Clinical Research Associates, Inc. Nashville Tennessee Recruiting
FutureSearch Trials of Neurology Austin Texas Recruiting
FutureSearch Trials of Dallas Dallas Texas Recruiting
Highland Clinical Research Salt Lake City Utah Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07646613 on ClinicalTrials.gov ↗ ← All trials in the USA