Recruiting
Phase 2

ASY202

Sponsor:

Aspeya, Inc.

Code:

NCT07646613

Conditions

Migraine

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

ASY202

Placebo

Study Details

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.

Conditions

Migraine

Study ID

NCT07646613

Start date

May 19, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ASY202, Then Placebo

ASY202 is a pre-metered drug-device combination product containing DHE dry powder formulation for oral inhalation, delivered via a dry powder inhaler (DPI) device. In Treatment Period 1, participants will receive ASY202, followed by a washout period and subsequent administration of placebo in Treatment Period 2. The placebo consists of an inactive inhalation powder delivered via a matching DPI device.

experimental: Placebo, Then ASY202

In Treatment Period 1, participants will receive placebo inhalation powder delivered via a dry powder inhaler (DPI) device, followed by a washout period and subsequent administration of ASY202 in Treatment Period 2.

Interventions

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.

Primary outcome measure

  • Proportion of patients with freedom from headache pain at 2 hours post-dose [ Time Frame: 2 hours Post-Dose ]

Central Contacts and Locations

Central contacts

Eken

+41 76 358 88 30clinicaltrials@aspeya.com

Locations

Sunwise Clinical Research, Llc

Recruiting

Walnut Creek, California, United States, 94596

Contacts

Eken

+41 76 358 88 30clinicaltrials@aspeya.com

More Information

Sponsor

Aspeya, Inc.

Last update posted

Sep 2, 2026

Last verified

Sep, 2026

Keywords

  • Migraine
  • DHE
  • Dihydroergotamine Mesylate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Aspeya, Inc. on 2026-09-02.