Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 22, 2020

Detailed Description

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: AXS-07

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Axsome Therapeutics, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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