Migraine
Conditions
Keywords
Migraine, AXS-07, Meloxicam, Rizatriptan
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 placebo. This is a randomized, double-blind, single-dose, placebo-controlled trial. Subjects who successfully complete the screening period and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07 or placebo upon the earliest onset of migraine pain.
Interventions
AXS-07 tablet taken once upon the earliest onset of migraine pain.
DRUGPlacebo
Placebo tablet taken once upon the earliest onset of migraine pain.
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. 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 Achieving Headache Pain Freedom at Hour 2 | Hour 2 | Absence of headache pain at Hour 2 |
| Percentage of Subjects With Absence of Most Bothersome Symptom at Hour 2 | Hour 2 | Absence of Most Bothersome Symptom, defined at the onset of migraine at Hour 2 |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 41.7 years STANDARD_DEVIATION 11.58 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 8 Participants |
| Race/Ethnicity, Customized Black or African American | 17 Participants |
| Race/Ethnicity, Customized Multiple | 4 Participants |
| Race/Ethnicity, Customized White | 234 Participants |
| Sex: Female, Male Female | 241 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 140 | 0 / 143 |
| other Total, other adverse events | 13 / 140 | 5 / 143 |
| serious Total, serious adverse events | 0 / 140 | 0 / 143 |
Outcome results
None listed