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Completed

NCT Number: NCT04068051

Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)

MOVEMENT (Multimechanistic Treatment over Time of Migraine Symptoms) is a Phase 3 study to evaluate the long-term safety of chronic intermittent use of AXS-07 and to assess the effect of AXS-07 on migraine symptoms following repeated treatment of migraine attacks.

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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

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About this study

This study is a Phase 3, multicenter, open-label, trial to evaluate the long-term safety and efficacy of intermittent chronic dosing with AXS-07 in subjects with migraine attacks. Eligible subjects will take AXS-07 following the onset of a migraine. Subjects will be treated for up to 12 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has participated in a prior study with AXS-07 for the treatment of migraine

Exclusion criteria

  • Has previously received any investigational drug or device or investigational therapy within 30 days before Screening, other than AXS-07
  • Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study

Treatment and study plan

AXS-07

Drug

AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.

Primary outcomes

  1. Long-term Safety of Chronic Intermittent Use of AXS-07

    Time frame: Up to 12 months

    Long-term safety as measured by:

    Subjects with any TEAEs

    Subjects with suspected to be drug-related TEAEs

    Subjects with serious TEAEs

    Subjects with TEAEs that led to drug withdrawal

    Subjects with TEAEs that led to withdrawal from study

    Subjects with TEAEs that resulted in death

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

An Open-Label, Long-Term Study to Assess the Safety and Efficacy of AXS-07 (MoSEIC™ Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2019
Registry last updated
Oct 10, 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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