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Completed Phase 3 Interventional Results available

Initiating Early Control of Migraine Pain and Associated Symptoms

ClinicalTrials.gov ID: NCT04163185

Public ClinicalTrials.gov record NCT04163185. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 6:29 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04163185
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Enrollment
302 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 8, 2019 (Actual)
Primary completion
Mar 16, 2020 (Actual)
Completion
Mar 23, 2020 (Actual)
Last update posted
Jan 28, 2026

2019 – 2020

United States locations

U.S. sites
41
U.S. states
19
U.S. cities
40
Facility City State ZIP Site status
Clinical Research Site Birmingham Alabama 35205 —
Clinical Research Site Birmingham Alabama 35216 —
Clinical Research Site Mobile Alabama 36608 —
Clinical Research Site Colton California 92399 —
Clinical Research Site Encino California 91316 —
Clinical Research Site Los Alamitos California 90720 —
Clinical Research Site Los Angeles California 90017 —
Clinical Research Site Redlands California 92374 —
Clinical Research Site Santa Monica California 90404 —
Clinical Research Site Spring Valley California 91978 —
Clinical Research Site Walnut Creek California 94598 —
Clinical Research Site Hallandale Florida 33009 —
Clinical Research Site Jacksonville Florida 32256 —
Clinical Research Site Lake City Florida 32055 —
Clinical Research Site Lake Worth Florida 33467 —
Clinical Research Site Ocoee Florida 34761 —
Clinical Research Site Orlando Florida 32801 —
Clinical Research Site Ormond Beach Florida 32174 —
Clinical Research Site South Miami Florida 33143 —
Clinical Research Site Sunrise Florida 33351 —
Clinical Research Site Tampa Florida 33634 —
Clinical Research Site Stockbridge Georgia 30281 —
Clinical Research Site Evanston Illinois 60201 —
Clinical Research Site Louisville Kentucky 40213 —
Clinical Research Site Boston Massachusetts 02131 —
Clinical Research Site Waltham Massachusetts 02451 —
Clinical Research Site Ann Arbor Michigan 48104 —
Clinical Research Site Springfield Missouri 65810 —
Clinical Research Site Albuquerque New Mexico 87102 —
Clinical Research Site Manlius New York 13104 —
Clinical Research Site Williamsville New York 14221 —
Clinical Research Site High Point North Carolina 27262 —
Clinical Research Site Oklahoma City Oklahoma 73106 —
Clinical Research Site Philadelphia Pennsylvania 19114 —
Clinical Research Site Charleston South Carolina 29406 —
Clinical Research Site Mt. Pleasant South Carolina 29464 —
Clinical Research Site Memphis Tennessee 38119 —
Clinical Research Site Nashville Tennessee 37203 —
Clinical Research Site Austin Texas 78731 —
Clinical Research Site Salt Lake City Utah 84107 —
Clinical Research Site Charlottesville Virginia 22911 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04163185, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 28, 2026 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04163185 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →