drugset / Trial / NCT04163185
Initiating Early Control of Migraine Pain and Associated Symptoms
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2019-10-08
- Primary completion
- 2020-03-16
- Completion
- 2020-03-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Meloxicam | Small molecule | — | Oral |
| Subject | rizatriptan | Unknown | — | Oral |