Phase 3
Completed N=1,594
Maximizing Outcomes in Treating Acute Migraine
Source: ClinicalTrials.gov NCT03896009 ↗Enrolled (actual)
1,594
Serious AEs
0.1%
Results posted
Aug 2023
Primary outcomePrimary: Percentage of Subjects Reporting Headache Pain Freedom — 85; 14 Participants — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Reporting Headache Pain Freedom |
85; 14 | <0.001 sig |
| PRIMARY Percentage of Subjects With Absence of Most Bothersome Symptom |
158; 51 | 0.002 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03896009). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.