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
| NCT ID | NCT07646613 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Aspeya, Inc. |
| Condition | Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2026-05-19 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 108 participants in total. It began in 2026-05-19 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07646613 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07646613 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07646613 currently recruiting?
Yes, NCT07646613 is actively recruiting participants. Contact the research team at clinicaltrials@aspeya.com for enrollment information.
Where is the NCT07646613 trial being conducted?
This trial is being conducted at Walnut Creek, United States, Las Vegas, United States, Salt Lake City, United States.
Who is sponsoring the NCT07646613 clinical trial?
NCT07646613 is sponsored by Aspeya, Inc.. The trial plans to enroll 108 participants.
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