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

NCT ID
NCT07646613
Registry status
Recruiting
Study type
Interventional
Phase
Phase 2
Sponsor
Aspeya, Inc.
Conditions
Migraine

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: A Randomized, Double-blind, Placebo-controlled, Crossover, Multi-center Clinical Trial for the Evaluation of Efficacy, Safety, and Tolerability of ASY202 for the Acute Treatment of Migraine in Adult Patients

Enrollment: 108 participants (Estimated).

What is being studied

  • Combination product: ASY202
  • Combination product: Placebo

Who may be eligible

Ages
18 Years to 65 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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

Study locations

6 study locations are listed.

Recruiting site status is explicitly provided for 6 locations; 1 is listed as Recruiting.

Countries: United States

  • California, United States: 1
  • Florida, United States: 2
  • Nevada, United States: 1
  • Tennessee, United States: 1
  • Utah, United States: 1

Sample of listed locations

  • Sunwise Clinical Research, Llc — Walnut Creek, California, 94596, United States — Recruiting
  • Clinical Neuroscineces Solutions — Orlando, Florida, 32806, United States — Not yet recruiting
  • Clinical Neuroscineces Solutions - Orlando — Orlando, Florida, 32801, United States — Not yet recruiting
  • M3 Wake Research - Las Vegas Rainbow — Las Vegas, Nevada, 89118, United States — Not yet recruiting
  • Clinical Research Associates, Inc. — Nashville, Tennessee, 37203, United States — Not yet recruiting
  • Highland Research — Salt Lake City, Utah, 84124, United States — Not yet recruiting

Study details

Start date
May 19, 2026
Primary completion date
March 1, 2027
Completion date
March 1, 2027
First posted
June 15, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07646613
Registry last updated
September 2, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07646613 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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