Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified August 2023 by Axsome Therapeutics, Inc.
Sponsor
Axsome Therapeutics, Inc.
Information Provided by (Responsible Party)
Axsome Therapeutics, Inc.
Clinicaltrials.gov Identifier
NCT04068051
Other Study ID Numbers:
AXS-07-302
First Submitted
July 26, 2019
First Posted
August 27, 2019
Results First Posted
September 14, 2023
Last Update Posted
October 9, 2023
Last Verified
August 2023

ClinicalTrials.gov processed this data on September 2023. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
Migraine
Drug: AXS-07

Study Design

Study TypeInterventional
Actual Enrollment706 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn 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 Start DateJuly 5, 2019
Actual Primary Completion DateSeptember 21, 2020
Actual Study Completion DateSeptember 21, 2020

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsAxsome Therapeutics, Inc.
Locations
Clinical Research Site | Birmingham Alabama, United States, 32516Clinical Research Site | Birmingham Alabama, United States, 32542Clinical Research Site | Mobile Alabama, United States, 36608Clinical Research Site | Phoenix Arizona, United States, 85004Clinical Research Site | Canoga Park California, United States, 91303Clinical Research Site | Colton California, United States, 92324Clinical Research Site | Encino California, United States, 91316Clinical Research Site | Los Alamitos California, United States, 90720Clinical Research Site | Los Angeles California, United States, 90017Clinical Research Site | Los Angeles California, United States, 90048Clinical Research Site | San Diego California, United States, 92103Clinical Research Site | Spring Valley California, United States, 91978Clinical Research Site | Walnut Creek California, United States, 94598Clinical Research Site | Hallandale Florida, United States, 33009Clinical Research Site | Jacksonville Florida, United States, 32256Clinical Research Site | Lake City Florida, United States, 32055Clinical Research Site | Lake Worth Florida, United States, 33467Clinical Research Site | Miami Florida, United States, 33155Clinical Research Site | Ocoee Florida, United States, 34761Clinical Research Site | Orlando Florida, United States, 32801Clinical Research Site | Ormond Beach Florida, United States, 32174Clinical Research Site | Tampa Florida, United States, 33634Clinical Research Site | Stockbridge Georgia, United States, 30281Clinical Research Site | Evanston Illinois, United States, 60201Clinical Research Site | Louisville Kentucky, United States, 40213Clinical Research Site | Boston Massachusetts, United States, 02131Clinical Research Site | North Dartmouth Massachusetts, United States, 02747Clinical Research Site | Waltham Massachusetts, United States, 02451Clinical Research Site | Ann Arbor Michigan, United States, 48104Clinical Research Site | Minneapolis Minnesota, United States, 55402Clinical Research Site | Springfield Missouri, United States, 65810Clinical Research Site | Las Vegas Nevada, United States, 89102Clinical Research Site | Albuquerque New Mexico, United States, 87102Clinical Research Site | Manlius New York, United States, 13104Clinical Research Site | Rochester New York, United States, 14609Clinical Research Site | Williamsville New York, United States, 14221Clinical Research Site | High Point North Carolina, United States, 27262Clinical Research Site | Cincinnati Ohio, United States, 45212Clinical Research Site | Columbus Ohio, United States, 43213Clinical Research Site | Oklahoma City Oklahoma, United States, 73106Clinical Research Site | Portland Oregon, United States, 97214Clinical Research Site | Salem Oregon, United States, 97301Clinical Research Site | Philadelphia Pennsylvania, United States, 19114Clinical Research Site | Charleston South Carolina, United States, 29406Clinical Research Site | Mt. Pleasant South Carolina, United States, 29464Clinical Research Site | Knoxville Tennessee, United States, 37920Clinical Research Site | Memphis Tennessee, United States, 38119Clinical Research Site | Austin Texas, United States, 78731Clinical Research Site | Salt Lake City Utah, United States, 84107Clinical Research Site | Charlottesville Virginia, United States, 22911Clinical Research Site | Seattle Washington, United States, 98105
Study Documents (Full Text)
Documents provided by Axsome Therapeutics, Inc.: Study Protocol and Statistical Analysis Plan  October 16, 2019