Initiating Early Control of Migraine Pain and Associated Symptoms
Completed · Phase 3 · Has a placebo group
Conditions studied: Migraine
In brief
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.
Key facts
- Study ID
- NCT04163185
- Run by
- Axsome Therapeutics, Inc.
- People needed
- 302
- Starts
- 2019-10-08
- Expected to finish
- 2020-03-23
- Last updated by the study team
- 2026-01-28
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Clinical Research Site — Birmingham, Alabama, United States
- Clinical Research Site — Birmingham, Alabama, United States
- Clinical Research Site — Mobile, Alabama, United States
- Clinical Research Site — Colton, California, United States
- Clinical Research Site — Encino, California, United States
- Clinical Research Site — Los Alamitos, California, United States
- Clinical Research Site — Los Angeles, California, United States
- Clinical Research Site — Redlands, California, United States
- Clinical Research Site — Santa Monica, California, United States
- Clinical Research Site — Spring Valley, California, United States
- Clinical Research Site — Walnut Creek, California, United States
- Clinical Research Site — Hallandale, Florida, United States
- Clinical Research Site — Jacksonville, Florida, United States
- Clinical Research Site — Lake City, Florida, United States
- Clinical Research Site — Lake Worth, Florida, United States
- Clinical Research Site — Ocoee, Florida, United States
- Clinical Research Site — Orlando, Florida, United States
- Clinical Research Site — Ormond Beach, Florida, United States
- Clinical Research Site — South Miami, Florida, United States
- Clinical Research Site — Sunrise, Florida, United States
- Clinical Research Site — Tampa, Florida, United States
- Clinical Research Site — Stockbridge, Georgia, United States
- Clinical Research Site — Evanston, Illinois, United States
- Clinical Research Site — Louisville, Kentucky, United States
- Clinical Research Site — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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