Migraine
Conditions
Keywords
Migraine, AXS-07, Meloxicam, Rizatriptan, Axsome, Axsome Therapeutics, MoSEIC meloxicam
Brief summary
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.
Interventions
AXS-07 taken once upon onset of a qualifying migraine.
DRUGMeloxicam
Meloxicam taken once upon onset of a qualifying migraine.
DRUGRizatriptan
Rizatriptan taken once upon onset of a qualifying migraine.
DRUGPlacebo
Placebo taken once upon onset of a qualifying migraine.
Sponsors
Axsome Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Has an established diagnosis of migraine with or without aura. * Has experienced an inadequate response to prior acute treatments. Key
Exclusion criteria
* Has previously received any investigational drug or device or investigational therapy within 30 days before Screening. * Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Reporting Headache Pain Freedom | Hour 2 following dose administration | Absence of headache pain. AXS-07 vs Placebo. |
| Percentage of Subjects With Absence of Most Bothersome Symptom | Hour 2 following dose administration | Absence of most bothersome symptom, defined at the onset of migraine. AXS-07 vs Placebo. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AXS-07 Taken once upon a qualifying migraine
AXS-07 (MoSEIC meloxicam and rizatriptan): AXS-07 taken once upon onset of a qualifying migraine. | 441 |
| Meloxicam Taken once upon a qualifying migraine
Meloxicam: Meloxicam taken once upon onset of a qualifying migraine. | 433 |
| Rizatriptan Taken once upon a qualifying migraine
Rizatriptan: Rizatriptan taken once upon onset of a qualifying migraine. | 434 |
| Placebo Taken once upon a qualifying migraine
Placebo: Placebo taken once upon onset of a qualifying migraine. | 218 |
| Total | 1,526 |
Baseline characteristics
| Characteristic | AXS-07 | Total | Placebo | Rizatriptan | Meloxicam |
|---|---|---|---|---|---|
| Age, Continuous | 41.1 years STANDARD_DEVIATION 11.64 | 41.1 years STANDARD_DEVIATION 11.54 | 41.0 years STANDARD_DEVIATION 11.71 | 41.5 years STANDARD_DEVIATION 10.75 | 41.0 years STANDARD_DEVIATION 12.13 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 7 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 29 Participants | 4 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 76 Participants | 296 Participants | 48 Participants | 84 Participants | 88 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 16 Participants | 4 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 11 Participants | 2 Participants | 5 Participants | 0 Participants |
| Race (NIH/OMB) White | 345 Participants | 1167 Participants | 160 Participants | 332 Participants | 330 Participants |
| Sex: Female, Male Female | 357 Participants | 1271 Participants | 185 Participants | 366 Participants | 363 Participants |
| Sex: Female, Male Male | 84 Participants | 255 Participants | 33 Participants | 68 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 441 | 0 / 433 | 0 / 434 | 0 / 218 |
| other Total, other adverse events | 49 / 441 | 50 / 433 | 67 / 434 | 13 / 218 |
| serious Total, serious adverse events | 1 / 441 | 0 / 433 | 0 / 434 | 0 / 218 |
Outcome results
Primary
Percentage of Subjects Reporting Headache Pain Freedom
Absence of headache pain. AXS-07 vs Placebo.
Time frame: Hour 2 following dose administration
Population: ITT population consists of all randomized subjects who received study drug and had a qualifying migraine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AXS-07 | Percentage of Subjects Reporting Headache Pain Freedom | 85 Participants |
| Placebo | Percentage of Subjects Reporting Headache Pain Freedom | 14 Participants |
p-value: <0.001Chi-squared
Primary
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
Population: ITT population consists of all randomized subjects who received study drug and had a qualifying migraine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AXS-07 | Percentage of Subjects With Absence of Most Bothersome Symptom | 158 Participants |
| Placebo | Percentage of Subjects With Absence of Most Bothersome Symptom | 51 Participants |
p-value: 0.002Chi-squared