Initiating Early Control of Migraine Pain and Associated Symptoms
INTERCEPT
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
1 other identifier
interventional
302
1 country
41
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2019
Shorter than P25 for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 8, 2019
CompletedFirst Submitted
Initial submission to the registry
November 12, 2019
CompletedFirst Posted
Study publicly available on registry
November 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2020
CompletedResults Posted
Study results publicly available
January 28, 2026
CompletedJanuary 28, 2026
January 1, 2026
5 months
November 12, 2019
March 18, 2023
January 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Subjects Achieving Headache Pain Freedom at Hour 2
Absence of headache pain at Hour 2
Hour 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
Hour 2
Study Arms (2)
AXS-07
EXPERIMENTALTaken once upon migraine
Placebo
PLACEBO COMPARATORTaken once upon migraine
Interventions
AXS-07 tablet taken once upon the earliest onset of migraine pain.
Eligibility Criteria
You may qualify if:
- Has an established diagnosis of migraine with or without aura.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Clinical Research Site
Birmingham, Alabama, 35205, United States
Clinical Research Site
Birmingham, Alabama, 35216, United States
Clinical Research Site
Mobile, Alabama, 36608, United States
Clinical Research Site
Colton, California, 92399, United States
Clinical Research Site
Encino, California, 91316, United States
Clinical Research Site
Los Alamitos, California, 90720, United States
Clinical Research Site
Los Angeles, California, 90017, United States
Clinical Research Site
Redlands, California, 92374, United States
Clinical Research Site
Santa Monica, California, 90404, United States
Clinical Research Site
Spring Valley, California, 91978, United States
Clinical Research Site
Walnut Creek, California, 94598, United States
Clinical Research Site
Hallandale, Florida, 33009, United States
Clinical Research Site
Jacksonville, Florida, 32256, United States
Clinical Research Site
Lake City, Florida, 32055, United States
Clinical Research Site
Lake Worth, Florida, 33467, United States
Clinical Research Site
Ocoee, Florida, 34761, United States
Clinical Research Site
Orlando, Florida, 32801, United States
Clinical Research Site
Ormond Beach, Florida, 32174, United States
Clinical Research Site
South Miami, Florida, 33143, United States
Clinical Research Site
Sunrise, Florida, 33351, United States
Clinical Research Site
Tampa, Florida, 33634, United States
Clinical Research Site
Stockbridge, Georgia, 30281, United States
Clinical Research Site
Evanston, Illinois, 60201, United States
Clinical Research Site
Louisville, Kentucky, 40213, United States
Clinical Research Site
Boston, Massachusetts, 02131, United States
Clinical Research Site
Waltham, Massachusetts, 02451, United States
Clinical Research Site
Ann Arbor, Michigan, 48104, United States
Clinical Research Site
Springfield, Missouri, 65810, United States
Clinical Research Site
Albuquerque, New Mexico, 87102, United States
Clinical Research Site
Manlius, New York, 13104, United States
Clinical Research Site
Williamsville, New York, 14221, United States
Clinical Research Site
High Point, North Carolina, 27262, United States
Clinical Research Site
Oklahoma City, Oklahoma, 73106, United States
Clinical Research Site
Philadelphia, Pennsylvania, 19114, United States
Clinical Research Site
Charleston, South Carolina, 29406, United States
Clinical Research Site
Mt. Pleasant, South Carolina, 29464, United States
Clinical Research Site
Memphis, Tennessee, 38119, United States
Clinical Research Site
Nashville, Tennessee, 37203, United States
Clinical Research Site
Austin, Texas, 78731, United States
Clinical Research Site
Salt Lake City, Utah, 84107, United States
Clinical Research Site
Charlottesville, Virginia, 22911, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Caroline Streicher, Executive Director, Clinical Operations
- Organization
- Axsome Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2019
First Posted
November 14, 2019
Study Start
October 8, 2019
Primary Completion
March 16, 2020
Study Completion
March 23, 2020
Last Updated
January 28, 2026
Results First Posted
January 28, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share