A Phase 3 interventional study of AXS-07 (MoSEIC meloxicam and rizatriptan) and Meloxicam in Migraine, sponsored by Axsome Therapeutics, Inc.. Completed at 85 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-08-24.
Sponsored by Axsome Therapeutics, Inc. · Phase 3, Interventional, and Treatment
AXS-07 is an oral, investigational medicine consisting of MoSEIC meloxicam and rizatriptan, which is being developed for the acute treatment of migraine with or without aura in adults. AXS-07 tablets are formulated to provide an enhanced rate of absorption of meloxicam. This study is designed to evaluate the efficacy and safety of AXS-07 compared to meloxicam, rizatriptan, and placebo for the treatment of a migraine attack.
This is a randomized, double-blind, 4-arm, parallel group, single-dose, placebo-controlled trial. Subjects who successfully complete screening and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07, meloxicam, rizatriptan, or placebo upon the occurrence of a qualifying migraine.
1,558 studies on the registry are indexed under Migraine Disorders; 301 are open to participants now.
This study's enrollment of 1,594 is above the median of 80 across 1,197 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Axsome Therapeutics, Inc. is the lead sponsor of 37 studies on the registry; 12 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 12 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Taken once upon a qualifying migraine
Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)
Taken once upon a qualifying migraine
Drug: Meloxicam
Taken once upon a qualifying migraine
Drug: Rizatriptan
Taken once upon a qualifying migraine
Drug: Placebo
Drug page: AXS-07
AXS-07 taken once upon onset of a qualifying migraine.
Meloxicam taken once upon onset of a qualifying migraine.
Rizatriptan taken once upon onset of a qualifying migraine.
Placebo taken once upon onset of a qualifying migraine.
Percentage of Subjects Reporting Headache Pain Freedom
Absence of headache pain. AXS-07 vs Placebo.
Time frame: Hour 2 following dose administration
Percentage of Subjects With Absence of Most Bothersome Symptom
Absence of most bothersome symptom, defined at the onset of migraine. AXS-07 vs Placebo.
Time frame: Hour 2 following dose administration
| Milestone | AXS-07 | Meloxicam | Rizatriptan | Placebo |
|---|---|---|---|---|
| Started | 456 | 455 | 456 | 227 |
| Completed | 441 | 433 | 434 | 218 |
| Not completed | 15 | 22 | 22 | 9 |
Absence of headache pain. AXS-07 vs Placebo.
| Participants | AXS-07 | Placebo |
|---|---|---|
| Percentage of Subjects Reporting Headache Pain Freedom | 85 | 14 |
Absence of most bothersome symptom, defined at the onset of migraine. AXS-07 vs Placebo.
| Participants | AXS-07 | Placebo |
|---|---|---|
| Percentage of Subjects With Absence of Most Bothersome Symptom | 158 | 51 |
Collected over Adverse events were collected after administration of study drug through the final visit (up to 1 week). Any AE was monitored up to a maximum of 30 days after the final visit.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AXS-07 | 0/441 (0%) | 1/441 (0.2%) | 49/441 (11.1%) |
| Meloxicam | 0/433 (0%) | 0/433 (0%) | 50/433 (11.5%) |
| Rizatriptan | 0/434 (0%) | 0/434 (0%) | 67/434 (15.4%) |
| Placebo | 0/218 (0%) | 0/218 (0%) | 13/218 (6%) |
| Event | AXS-07 | Meloxicam | Rizatriptan | Placebo |
|---|---|---|---|---|
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 1/441 | 0/433 | 0/434 | 0/218 |
| Event | AXS-07 | Meloxicam | Rizatriptan | Placebo |
|---|---|---|---|---|
| All Others, occurring in <1% of SubjectsGeneral disorders | 28/441 | 22/433 | 32/434 | 2/218 |
| NauseaGastrointestinal disorders | 12/441 | 14/433 | 21/434 | 8/218 |
| SomnolenceNervous system disorders | 6/441 | 10/433 | 9/434 | 1/218 |
| DizzinessNervous system disorders | 7/441 | 5/433 | 9/434 | 2/218 |
Safety Population includes all subjects who received study drug.
| Age, Continuous(years) | AXS-07 | Meloxicam | Rizatriptan | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 41.1 ± 11.64 | 41.0 ± 12.13 | 41.5 ± 10.75 | 41.0 ± 11.71 | 41.1 ± 11.54 |
| Sex: Female, Male(Participants) | AXS-07 | Meloxicam | Rizatriptan | Placebo | Total |
|---|---|---|---|---|---|
| Female | 357 | 363 | 366 | 185 | 1271 |
| Male | 84 | 70 | 68 | 33 | 255 |
| Race (NIH/OMB)(Participants) | AXS-07 | Meloxicam | Rizatriptan | Placebo | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 4 | 1 | 2 | 0 | 7 |
| Asian | 9 | 10 | 6 | 4 | 29 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 76 | 88 | 84 | 48 | 296 |
| White | 345 | 330 | 332 | 160 | 1167 |
| More than one race | 3 | 4 | 5 | 4 | 16 |
| Unknown or Not Reported | 4 | 0 | 5 | 2 | 11 |
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: AXS-07