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Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AXS-07
Sponsored by
Axsome Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Axsome, AXS-07, MoSEIC™ meloxicam, rizatriptan

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AXS-07

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 27, 2019
Last Updated
September 15, 2023
Sponsor
Axsome Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04068051
Brief Title
Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 6, 2019 (Actual)
Primary Completion Date
September 22, 2020 (Actual)
Study Completion Date
September 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axsome Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Axsome, AXS-07, MoSEIC™ meloxicam, rizatriptan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
706 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AXS-07
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AXS-07
Intervention Description
AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.
Primary Outcome Measure Information:
Title
Long-term Safety of Chronic Intermittent Use of AXS-07
Description
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
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Clinical Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
32516
Country
United States
Facility Name
Clinical Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
32542
Country
United States
Facility Name
Clinical Research Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Clinical Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Clinical Research Site
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Clinical Research Site
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
Clinical Research Site
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Clinical Research Site
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Clinical Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Clinical Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Clinical Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Clinical Research Site
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Clinical Research Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Clinical Research Site
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Clinical Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Clinical Research Site
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
Clinical Research Site
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Clinical Research Site
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Clinical Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Clinical Research Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Clinical Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Clinical Research Site
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Clinical Research Site
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Clinical Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Clinical Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Clinical Research Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Clinical Research Site
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
Clinical Research Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Clinical Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Clinical Research Site
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Facility Name
Clinical Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Clinical Research Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Clinical Research Site
City
Manlius
State/Province
New York
ZIP/Postal Code
13104
Country
United States
Facility Name
Clinical Research Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Clinical Research Site
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Clinical Research Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Clinical Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Clinical Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Clinical Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Facility Name
Clinical Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97214
Country
United States
Facility Name
Clinical Research Site
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Clinical Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Clinical Research Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Clinical Research Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Clinical Research Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Clinical Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Clinical Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Clinical Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Clinical Research Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Clinical Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)

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