New migraine combo drug shows promise for Tough-to-Treat patients
NCT ID NCT05550207
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new drug called AXS-07, which combines meloxicam and rizatriptan, for treating migraine attacks in adults. The 100 participants had previously not gotten enough relief from oral CGRP inhibitors. The goal was to see if the drug could relieve headache pain and other bothersome symptoms without needing rescue medication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AXS-07 (a combination of meloxicam and rizatriptan)
- What this could lead to
- If successful, this could provide a new acute treatment option for people with migraine who have not gotten relief from oral CGRP inhibitors.
- What could go wrong
- This is an open-label study with no placebo group, so results may be less reliable. The combination drug may cause side effects like dizziness or drowsiness.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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100 people
The number who actually took part.
- Started
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Aug 2022
- Finished
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Nov 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Has an established diagnosis of migraine with or without aura * Has experienced an inadequate response to oral CGRP inhibitors for the acute treatment of migraine Exclusion Criteria: * Pregnant, breastfeeding, or planning to become pregnant during the study * Has previously received any investigational drug or device or investigational therapy within 30 days before Screening
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Clinical Research Site
Colton, California, 92324, United States
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Clinical Research Site
Fullerton, California, 92835, United States
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Clinical Research Site
La Jolla, California, 92037, United States
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Clinical Research Site
Los Angeles, California, 90067, United States
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Clinical Research Site
Sherman Oaks, California, 91403, United States
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Clinical Research Site
Stamford, Connecticut, 06905, United States
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Clinical Research Site
DeLand, Florida, 32720, United States
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Clinical Research Site
Hallandale, Florida, 33009, United States
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Clinical Research Site
Hollywood, Florida, 33024, United States
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Clinical Research Site
Miami, Florida, 33126, United States
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Clinical Research Site
Ormond Beach, Florida, 31274, United States
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Clinical Research Site
Oviedo, Florida, 32765, United States
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Clinical Research Site
Pensacola, Florida, 32504, United States
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Clinical Research Site
Winter Park, Florida, 32789, United States
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Clinical Research Site
Stockbridge, Georgia, 30281, United States
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Clinical Research Site
Avon, Indiana, 46123, United States
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Clinical Research Site
Boston, Massachusetts, 02131, United States
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Clinical Research Site
North Dartmouth, Massachusetts, 02747, United States
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Clinical Research Site
Las Vegas, Nevada, 89102, United States
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Clinical Research Site
Albuquerque, New Mexico, 87102, United States
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Clinical Research Site
The Bronx, New York, 10466, United States
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Clinical Research Site
Williamsville, New York, 14221, United States
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Clinical Research Site
Philadelphia, Pennsylvania, 19114, United States
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Clinical Research Site
Charleston, South Carolina, 29406, United States
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Clinical Research Site
Knoxville, Tennessee, 37909, United States
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Clinical Research Site
Nashville, Tennessee, 37203, United States
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Clinical Research Site
Cypress, Texas, 77429, United States
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Clinical Research Site
Sugar Land, Texas, 77478, United States
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Clinical Research Site
Salt Lake City, Utah, 84107, United States
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Clinical Research Site
Charlottesville, Virginia, 22911, United States
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Clinical Research Site
McLean, Virginia, 22101, United States
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