Initiating Early Control of Migraine Pain and Associated Symptoms

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified December 2025 by Axsome Therapeutics, Inc.
Sponsor
Axsome Therapeutics, Inc.
Information Provided by (Responsible Party)
Axsome Therapeutics, Inc.
Clinicaltrials.gov Identifier
NCT04163185
Other Study ID Numbers:
AXS-07-303
First Submitted
November 11, 2019
First Posted
November 13, 2019
Results First Posted
March 17, 2023
Last Update Posted
January 27, 2026
Last Verified
December 2025

ClinicalTrials.gov processed this data on January 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Migraine
Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment302 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA 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
Study Start DateOctober 7, 2019
Actual Primary Completion DateMarch 15, 2020
Actual Study Completion DateMarch 22, 2020

Groups and Cohorts

Group/CohortIntervention/Treatment
AXS-07
Taken once upon migraine
Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)
AXS-07 tablet taken once upon the earliest onset of migraine pain.
Placebo
Taken once upon migraine
Drug: Placebo
Placebo tablet taken once upon the earliest onset of migraine pain.

Outcome Measures

Primary Outcome Measures
  1. Percentage of Subjects Achieving Headache Pain Freedom at Hour 2
    Absence of headache pain at Hour 2
  2. Percentage of Subjects With Absence of Most Bothersome Symptom at Hour 2
    Absence of Most Bothersome Symptom, defined at the onset of migraine at Hour 2

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsAxsome Therapeutics, Inc.
Locations
Clinical Research Site | Birmingham Alabama, United States, 35205Clinical Research Site | Birmingham Alabama, United States, 35216Clinical Research Site | Mobile Alabama, United States, 36608Clinical Research Site | Colton California, United States, 92399Clinical Research Site | Encino California, United States, 91316Clinical Research Site | Los Alamitos California, United States, 90720Clinical Research Site | Los Angeles California, United States, 90017Clinical Research Site | Redlands California, United States, 92374Clinical Research Site | Santa Monica California, United States, 90404Clinical Research Site | Spring Valley California, United States, 91978Clinical Research Site | Walnut Creek California, United States, 94598Clinical Research Site | Hallandale Florida, United States, 33009Clinical Research Site | Jacksonville Florida, United States, 32256Clinical Research Site | Lake City Florida, United States, 32055Clinical Research Site | Lake Worth Florida, United States, 33467Clinical Research Site | Ocoee Florida, United States, 34761Clinical Research Site | Orlando Florida, United States, 32801Clinical Research Site | Ormond Beach Florida, United States, 32174Clinical Research Site | South Miami Florida, United States, 33143Clinical Research Site | Sunrise Florida, United States, 33351Clinical Research Site | Tampa Florida, United States, 33634Clinical Research Site | Stockbridge Georgia, United States, 30281Clinical Research Site | Evanston Illinois, United States, 60201Clinical Research Site | Louisville Kentucky, United States, 40213Clinical Research Site | Boston Massachusetts, United States, 02131Clinical Research Site | Waltham Massachusetts, United States, 02451Clinical Research Site | Ann Arbor Michigan, United States, 48104Clinical Research Site | Springfield Missouri, United States, 65810Clinical Research Site | Albuquerque New Mexico, United States, 87102Clinical Research Site | Manlius New York, United States, 13104Clinical Research Site | Williamsville New York, United States, 14221Clinical Research Site | High Point North Carolina, United States, 27262Clinical Research Site | Oklahoma City Oklahoma, United States, 73106Clinical Research Site | Philadelphia Pennsylvania, United States, 19114Clinical Research Site | Charleston South Carolina, United States, 29406Clinical Research Site | Mt. Pleasant South Carolina, United States, 29464Clinical Research Site | Memphis Tennessee, United States, 38119Clinical Research Site | Nashville Tennessee, United States, 37203Clinical Research Site | Austin Texas, United States, 78731Clinical Research Site | Salt Lake City Utah, United States, 84107Clinical Research Site | Charlottesville Virginia, United States, 22911
Study Documents (Full Text)
Documents provided by Axsome Therapeutics, Inc.: Study Protocol  December 12, 2019Documents provided by Axsome Therapeutics, Inc.: Statistical Analysis Plan  March 11, 2020