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Inhaled powder could offer rapid migraine relief without needles

NCT ID NCT07646613

Symptom relief Sponsor: Aspeya, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 4 times

Summary

This study tests an investigational inhaled medication called ASY202 (dihydroergotamine dry powder) for treating migraine attacks in adults. Participants use a handheld inhaler to take the drug or a placebo during separate migraine episodes, and neither they nor the study team know which is which. The goal is to see if ASY202 can stop headache pain and bothersome symptoms like light sensitivity or nausea within two hours. The trial involves about 108 people and lasts around 16 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dihydroergotamine (DHE) inhaled dry powder
What this could lead to
If successful, this could provide a fast-acting, non-injectable option for treating migraine attacks at home.
What could go wrong
This is an early-phase trial with only 108 participants, so results may not apply to everyone. Inhaled DHE may cause side effects like throat irritation or nausea.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 108 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Clinical Neuroscineces Solutions

    NOT_YET_RECRUITING

    Orlando, Florida, 32806, United States

    Contact Email: •••••@•••••

  • Clinical Neuroscineces Solutions - Orlando

    NOT_YET_RECRUITING

    Orlando, Florida, 32801, United States

    Contact Email: •••••@•••••

  • Clinical Research Associates, Inc.

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37203, United States

    Contact Email: •••••@•••••

  • Highland Research

    NOT_YET_RECRUITING

    Salt Lake City, Utah, 84124, United States

    Contact Email: •••••@•••••

  • M3 Wake Research - Las Vegas Rainbow

    NOT_YET_RECRUITING

    Las Vegas, Nevada, 89118, United States

    Contact Email: •••••@•••••

  • Sunwise Clinical Research, Llc

    RECRUITING

    Walnut Creek, California, 94596, United States

    Contact Email: •••••@•••••

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