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Tests treatment safety and results for Migraine
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 medicine, given as a pill taken by mouth, being studied as a potential treatment for migraine.
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
- 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.
- 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...
- Female participants must be either:
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)
- Female participants must be either:
- 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. These conditions...
- 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's taking place
- Walnut Creek, California, United States
- Orlando, Florida, United States
- Las Vegas, Nevada, United States
- Nashville, Tennessee, 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 - 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?
Study sites include Walnut Creek, California, United States; Orlando, Florida, United States; Las Vegas, Nevada, United States; Nashville, Tennessee, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.