New inhaled migraine treatment shows promise in early trial
NCT ID NCT07226362
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tested a new inhaled powder form of the migraine drug dihydroergotamine (DHE) in 44 healthy adults. Researchers compared how the body absorbs the drug when inhaled versus when given as a nasal spray or injection. The goal was to check safety and measure drug levels, not to treat migraines.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dihydroergotamine mesylate (DHE)
- What this could lead to
- If successful, this could lead to a new, easier-to-use inhaled form of DHE for migraine attacks.
- What could go wrong
- This is an early Phase 1 study in healthy people, not migraine patients. It only checks safety and how the drug moves in the body, not if it works for migraines.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
44 people
The number who actually took part.
- Started
-
Jun 2025
- Finished
-
Oct 2025
- 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 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Subjects must meet all the following criteria to be included in the study: 1. Male or female, ≥ 18 and ≤ 55 years of age, with body mass index (BMI) \>18.5 and \< 32.0 kg/m2 2. Healthy subjects 3. Female subjects of non-childbearing potential or childbearing potential willing to use protocol required methods of contraception 4. Current non-smoker 5. Able to understand the study procedures and provide signed informed consent to participate in the study. Exclusion Criteria: * Subjects to whom any of the following applies will be excluded from the study: 1. Positive pregnancy test or lactating female subjects at screening or on Day 1 of each treatment period 2. Clinically significant abnormal laboratory or serology test results 3. History or current diagnosis of uncontrolled or significant cardiac disease 4. Significant risk factors for cardiovascular disease 5. Subject with abnormal lung function at screening 6. History or current diagnosis of lung disease e.g. asthma, COPD 7. Known allergic reactions, hypersensitivity or contraindications to DHE, other ergot-derived products or to any excipient 8. History of drug or alcohol abuse
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Alliance for Multispecialty research (AMR)
Knoxville, Tennessee, 37920, United States
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