Migraine study: ASY202
Official title 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
ClinicalTrials.gov ID: NCT07646613
What this study is testing
What is ASY202?
ASY202 is an investigational inhaled powder being studied as a potential treatment for migraine attacks. is designed to deliver dihydroergotamine to the lungs through a handheld inhaler to help treat migraine symptoms.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how well ASY202 works, how safe it is, and how well people can tolerate it.
- Who it's for
- Adults who have migraine attacks.
- What's involved
- Participants will use a handheld dry powder inhaler to treat migraine attacks. They will receive both the study drug and a placebo in different periods, but neither they nor the staff will know which is which at the time.
- Time commitment
- The study lasts about 16 weeks, including a screening period, two treatment periods separated by at least 7 days, and a safety follow‑up visit.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- of non-childbearing potential, or
You likely can't join if
- 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...
- 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...
- Known history or current diagnosis of psychological and/or psychiatric condition that, in the opinion of the Investigator, might interfere with study...
See the full eligibility 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)
- of non-childbearing potential, or
- of childbearing potential using protocol required contraception
- 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...
- 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.
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Lemon Grove, California, United States
- Walnut Creek, California, United States
- Stamford, Connecticut, United States
- Waterbury, Connecticut, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Roslindale, Massachusetts, United States
- Westborough, Massachusetts, United States
- City of Saint Peters, Missouri, United States
- Las Vegas, Nevada, United States
- Marlton, New Jersey, United States
- Brooklyn, New York, United States
- Raleigh, North Carolina, United States
- Memphis, Tennessee, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Lemon Grove, California, United States; Walnut Creek, California, United States; Stamford, Connecticut, United States; Waterbury, Connecticut, United States; Orlando, Florida, United States and 13 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.