Maximizing Outcomes in Treating Acute Migraine

NCT03896009 | Completed Phase 3 Results FDA Drug

• 1 other identifier: AXS-07-301
• Study Type: interventional
• Target: 1,594
• Locations: 1 country
• Sites: 85

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 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.

Conditions

Migraine

Keywords

Migraine; AXS-07; Meloxicam; Rizatriptan; Axsome; Axsome Therapeutics; MoSEIC meloxicam

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects Reporting Headache Pain Freedom

  Absence of headache pain. AXS-07 vs Placebo.

  Hour 2 following dose administration

• Percentage of Subjects With Absence of Most Bothersome Symptom

  Absence of most bothersome symptom, defined at the onset of migraine. AXS-07 vs Placebo.

  Hour 2 following dose administration

Study Arms (4)

AXS-07

EXPERIMENTAL

Taken once upon a qualifying migraine

Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)

Meloxicam

ACTIVE COMPARATOR

Taken once upon a qualifying migraine

Drug: Meloxicam

Rizatriptan

ACTIVE COMPARATOR

Taken once upon a qualifying migraine

Drug: Rizatriptan

Placebo

PLACEBO COMPARATOR

Taken once upon a qualifying migraine

Drug: Placebo

Interventions

AXS-07 (MoSEIC meloxicam and rizatriptan) DRUG

AXS-07 taken once upon onset of a qualifying migraine.

AXS-07

Meloxicam DRUG

Meloxicam taken once upon onset of a qualifying migraine.

Meloxicam

Rizatriptan DRUG

Rizatriptan taken once upon onset of a qualifying migraine.

Rizatriptan

Placebo DRUG

Placebo taken once upon onset of a qualifying migraine.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has an established diagnosis of migraine with or without aura.
• Has experienced an inadequate response to prior acute treatments.

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.

Sponsors & Collaborators

• Axsome Therapeutics, Inc.: lead

Study Sites (85)

Clinical Research Site

Birmingham, Alabama, 35205, United States

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Clinical Research Site

Birmingham, Alabama, 35216, United States

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Mobile, Alabama, 36608, United States

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Phoenix, Arizona, 85004, United States

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Tempe, Arizona, 85283, United States

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Little Rock, Arkansas, 72209, United States

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Canoga Park, California, 91303, United States

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Colton, California, 92399, United States

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Culver City, California, 90230, United States

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Encino, California, 91316, United States

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Los Alamitos, California, 90720, United States

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Los Angeles, California, 90017, United States

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Oceanside, California, 92506, United States

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Pomona, California, 91767, United States

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Redlands, California, 92374, United States

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Riverside, California, 92503, United States

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San Diego, California, 92103, United States

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Santa Monica, California, 90404, United States

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Spring Valley, California, 91978, United States

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Walnut Creek, California, 94598, United States

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Waterbury, Connecticut, 06708, United States

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Clermont, Florida, 34711, United States

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DeLand, Florida, 32720, United States

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Fernandina Beach, Florida, 32034, United States

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Hallandale, Florida, 33009, United States

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Hialeah, Florida, 33012, United States

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Hollywood, Florida, 33024, United States

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Jacksonville, Florida, 32256, United States

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Lake City, Florida, 32055, United States

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Lake Worth, Florida, 33467, United States

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Miami, Florida, 33155, United States

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Ocoee, Florida, 34761, United States

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Orange City, Florida, 32763, United States

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Orlando, Florida, 32801, United States

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Ormond Beach, Florida, 32174, United States

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South Miami, Florida, 33143, United States

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Sunrise, Florida, 33351, United States

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Tampa, Florida, 33634, United States

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Atlanta, Georgia, 30312, United States

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Atlanta, Georgia, 30331, United States

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Stockbridge, Georgia, 30281, United States

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Meridian, Idaho, 83642, United States

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Evanston, Illinois, 60201, United States

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Lenexa, Kansas, 66214, United States

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Lexington, Kentucky, 40509, United States

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Louisville, Kentucky, 40213, United States

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New Orleans, Louisiana, 70125, United States

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Boston, Massachusetts, 02131, United States

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North Dartmouth, Massachusetts, 02747, United States

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Watertown, Massachusetts, 02472, United States

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Ann Arbor, Michigan, 48104, United States

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Minneapolis, Minnesota, 55402, United States

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Kansas City, Missouri, 64114, United States

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Springfield, Missouri, 65810, United States

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Las Vegas, Nevada, 89102, United States

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Berlin, New Jersey, 08009, United States

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Toms River, New Jersey, 08755, United States

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Albuquerque, New Mexico, 87102, United States

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Endwell, New York, 12760, United States

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Manlius, New York, 13104, United States

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New York, New York, 10017, United States

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Rochester, New York, 14609, United States

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The Bronx, New York, 10461, United States

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Williamsville, New York, 14221, United States

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High Point, North Carolina, 27262, United States

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Wilmington, North Carolina, 24801, United States

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Cincinnati, Ohio, 45212, United States

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Cleveland, Ohio, 44122, United States

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Dublin, Ohio, 43016, United States

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Oklahoma City, Oklahoma, 73106, United States

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Portland, Oregon, 97214, United States

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Salem, Oregon, 97301, United States

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Philadelphia, Pennsylvania, 19114, United States

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Charleston, South Carolina, 29406, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Knoxville, Tennessee, 37920, United States

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Memphis, Tennessee, 38119, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78731, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84107, United States

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Clinical Research Site

Charlottesville, Virginia, 22911, United States

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Norfolk, Virginia, 23507, United States

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Bellevue, Washington, 98007, United States

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Clinical Research Site

Seattle, Washington, 98105, United States

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Related Links

• Axsome Therapeutics Website

MeSH Terms

Conditions

Migraine Disorders

Interventions

rizatriptan; Meloxicam

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Caroline Streicher, Executive Director, Clinical Operations
• Organization: Axsome Therapeutics, Inc.

cstreicher@axsome.com

212-332-5061

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: March 15, 2019
• First Posted: March 29, 2019
• Study Start: March 4, 2019
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: August 24, 2023
• Results First Posted: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (85)