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Completed

NCT Number: NCT03896009

Maximizing Outcomes in Treating Acute Migraine

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AXS-07 (MoSEIC meloxicam and rizatriptan)

Drug

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

Meloxicam

Drug

Meloxicam taken once upon onset of a qualifying migraine.

Rizatriptan

Drug

Rizatriptan taken once upon onset of a qualifying migraine.

Placebo

Drug

Placebo taken once upon onset of a qualifying migraine.

Primary outcomes

  1. Percentage of Subjects Reporting Headache Pain Freedom

    Time frame: Hour 2 following dose administration

    Absence of headache pain. AXS-07 vs Placebo.

  2. Percentage of Subjects With Absence of Most Bothersome Symptom

    Time frame: Hour 2 following dose administration

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

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

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

Acronym: MOMENTUM

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2019
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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