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MOMENTUM: A Randomized, Double-blind, Single-dose, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Clinical Research Site
Birmingham, Alabama, United States
Clinical Research Site
Birmingham, Alabama, United States
Clinical Research Site
Mobile, Alabama, United States
Clinical Research Site
Phoenix, Arizona, United States
Clinical Research Site
Tempe, Arizona, United States
Clinical Research Site
Little Rock, Arkansas, United States
Clinical Research Site
Canoga Park, California, United States
Clinical Research Site
Colton, California, United States
Clinical Research Site
Culver City, California, United States
Clinical Research Site
Encino, California, United States
Start Date
March 4, 2019
Primary Completion Date
December 10, 2019
Completion Date
December 10, 2019
Last Updated
August 24, 2023
1,594
ACTUAL participants
AXS-07 (MoSEIC meloxicam and rizatriptan)
DRUG
Meloxicam
DRUG
Rizatriptan
DRUG
Placebo
DRUG
Lead Sponsor
Axsome Therapeutics, Inc.
NCT06641466
NCT07018713
NCT04715685
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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