Maximizing Outcomes in Treating Acute Migraine (MOMENTUM)

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: AXS-07 (MoSEIC meloxicam and rizatriptan); Drug: Meloxicam; Drug: Rizatriptan; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1594
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Clinical Research Site
    • Birmingham, Alabama, United States, 35216
      • Clinical Research Site
    • Mobile, Alabama, United States, 36608
      • Clinical Research Site
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Clinical Research Site
    • Tempe, Arizona, United States, 85283
      • Clinical Research Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72209
      • Clinical Research Site
  • California
    • Canoga Park, California, United States, 91303
      • Clinical Research Site
    • Colton, California, United States, 92399
      • Clinical Research Site
    • Culver City, California, United States, 90230
      • Clinical Research Site
    • Encino, California, United States, 91316
      • Clinical Research Site
    • Los Alamitos, California, United States, 90720
      • Clinical Research Site
    • Los Angeles, California, United States, 90017
      • Clinical Research Site
    • Oceanside, California, United States, 92506
      • Clinical Research Site
    • Pomona, California, United States, 91767
      • Clinical Research Site
    • Redlands, California, United States, 92374
      • Clinical Research Site
    • Riverside, California, United States, 92503
      • Clinical Research Site
    • San Diego, California, United States, 92103
      • Clinical Research Site
    • Santa Monica, California, United States, 90404
      • Clinical Research Site
    • Spring Valley, California, United States, 91978
      • Clinical Research Site
    • Walnut Creek, California, United States, 94598
      • Clinical Research Site
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Clinical Research Site
  • Florida
    • Clermont, Florida, United States, 34711
      • Clinical Research Site
    • DeLand, Florida, United States, 32720
      • Clinical Research Site
    • Fernandina Beach, Florida, United States, 32034
      • Clinical Research Site
    • Hallandale Beach, Florida, United States, 33009
      • Clinical Research Site
    • Hialeah, Florida, United States, 33012
      • Clinical Research Site
    • Hollywood, Florida, United States, 33024
      • Clinical Research Site
    • Jacksonville, Florida, United States, 32256
      • Clinical Research Site
    • Lake City, Florida, United States, 32055
      • Clinical Research Site
    • Lake Worth, Florida, United States, 33467
      • Clinical Research Site
    • Miami, Florida, United States, 33155
      • Clinical Research Site
    • Ocoee, Florida, United States, 34761
      • Clinical Research Site
    • Orange City, Florida, United States, 32763
      • Clinical Research Site
    • Orlando, Florida, United States, 32801
      • Clinical Research Site
    • Ormond Beach, Florida, United States, 32174
      • Clinical Research Site
    • South Miami, Florida, United States, 33143
      • Clinical Research Site
    • Sunrise, Florida, United States, 33351
      • Clinical Research Site
    • Tampa, Florida, United States, 33634
      • Clinical Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30312
      • Clinical Research Site
    • Atlanta, Georgia, United States, 30331
      • Clinical Research Site
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Site
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Clinical Research Site
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Clinical Research Site
  • Kansas
    • Lenexa, Kansas, United States, 66214
      • Clinical Research Site
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Clinical Research Site
    • Louisville, Kentucky, United States, 40213
      • Clinical Research Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70125
      • Clinical Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Clinical Research Site
    • North Dartmouth, Massachusetts, United States, 02747
      • Clinical Research Site
    • Watertown, Massachusetts, United States, 02472
      • Clinical Research Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Clinical Research Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Site
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Clinical Research Site
    • Springfield, Missouri, United States, 65810
      • Clinical Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Clinical Research Site
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Clinical Research Site
    • Toms River, New Jersey, United States, 08755
      • Clinical Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Clinical Research Site
  • New York
    • Bronx, New York, United States, 10461
      • Clinical Research Site
    • Endwell, New York, United States, 12760
      • Clinical Research Site
    • Manlius, New York, United States, 13104
      • Clinical Research Site
    • New York, New York, United States, 10017
      • Clinical Research Site
    • Rochester, New York, United States, 14609
      • Clinical Research Site
    • Williamsville, New York, United States, 14221
      • Clinical Research Site
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Clinical Research Site
    • Wilmington, North Carolina, United States, 24801
      • Clinical Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • Clinical Research Site
    • Cleveland, Ohio, United States, 44122
      • Clinical Research Site
    • Dublin, Ohio, United States, 43016
      • Clinical Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73106
      • Clinical Research Site
  • Oregon
    • Portland, Oregon, United States, 97214
      • Clinical Research Site
    • Salem, Oregon, United States, 97301
      • Clinical Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research Site
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Clinical Research Site
    • Mount Pleasant, South Carolina, United States, 29464
      • Clinical Research Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Clinical Research Site
    • Memphis, Tennessee, United States, 38119
      • Clinical Research Site
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Site
  • Texas
    • Austin, Texas, United States, 78731
      • Clinical Research Site
    • San Antonio, Texas, United States, 78229
      • Clinical Research Site
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Clinical Research Site
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Clinical Research Site
    • Norfolk, Virginia, United States, 23507
      • Clinical Research Site
  • Washington
    • Bellevue, Washington, United States, 98007
      • Clinical Research Site
    • Seattle, Washington, United States, 98105
      • Clinical Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AXS-07; Taken once upon a qualifying migraine	Drug: AXS-07 (MoSEIC meloxicam and rizatriptan); AXS-07 taken once upon onset of a qualifying migraine.
Active Comparator: Meloxicam; Taken once upon a qualifying migraine	Drug: Meloxicam; Meloxicam taken once upon onset of a qualifying migraine.
Active Comparator: Rizatriptan; Taken once upon a qualifying migraine	Drug: Rizatriptan; Rizatriptan taken once upon onset of a qualifying migraine.
Placebo Comparator: Placebo; Taken once upon a qualifying migraine	Drug: Placebo; Placebo taken once upon onset of a qualifying migraine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects reporting sustained headache pain freedom	Sustained headache pain freedom without use of rescue medication and no relapse of headache pain	Hours 2 through 24 following dose administration
Percentage of subjects reporting headache pain relief	Mild or no headache pain	Hour 2 following dose administration

Collaborators and Investigators

• Sponsor: Axsome Therapeutics, Inc.

Publications and helpful links

Helpful Links

• Axsome Therapeutics Website

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2019
• Primary Completion (Actual): December 10, 2019
• Study Completion (Actual): December 10, 2019

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): March 29, 2019

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Migraine; Axsome; AXS-07; Meloxicam; Rizatriptan; Axsome Therapeutics; MoSEIC meloxicam
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Serotonin Agents; Serotonin Receptor Agonists; Cyclooxygenase 2 Inhibitors; Meloxicam; Rizatriptan
• Other Study ID Numbers: AXS-07-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No