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Maximizing Outcomes in Treating Acute Migraine (MOMENTUM)

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AXS-07 (MoSEIC meloxicam and rizatriptan)
Meloxicam
Rizatriptan
Placebo
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 Migraine, AXS-07, Meloxicam, Rizatriptan, Axsome, Axsome Therapeutics, MoSEIC meloxicam

Eligibility Criteria

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

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

AXS-07

Meloxicam

Rizatriptan

Placebo

Arm Description

Taken once upon a qualifying migraine

Taken once upon a qualifying migraine

Taken once upon a qualifying migraine

Taken once upon a qualifying migraine

Outcomes

Primary Outcome Measures

Percentage of Subjects Reporting Headache Pain Freedom
Absence of headache pain. AXS-07 vs Placebo.
Percentage of Subjects With Absence of Most Bothersome Symptom
Absence of most bothersome symptom, defined at the onset of migraine. AXS-07 vs Placebo.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2019
Last Updated
August 22, 2023
Sponsor
Axsome Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03896009
Brief Title
Maximizing Outcomes in Treating Acute Migraine
Acronym
MOMENTUM
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
December 10, 2019 (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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1594 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AXS-07
Arm Type
Experimental
Arm Description
Taken once upon a qualifying migraine
Arm Title
Meloxicam
Arm Type
Active Comparator
Arm Description
Taken once upon a qualifying migraine
Arm Title
Rizatriptan
Arm Type
Active Comparator
Arm Description
Taken once upon a qualifying migraine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Taken once upon a qualifying migraine
Intervention Type
Drug
Intervention Name(s)
AXS-07 (MoSEIC meloxicam and rizatriptan)
Intervention Description
AXS-07 taken once upon onset of a qualifying migraine.
Intervention Type
Drug
Intervention Name(s)
Meloxicam
Intervention Description
Meloxicam taken once upon onset of a qualifying migraine.
Intervention Type
Drug
Intervention Name(s)
Rizatriptan
Intervention Description
Rizatriptan taken once upon onset of a qualifying migraine.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo taken once upon onset of a qualifying migraine.
Primary Outcome Measure Information:
Title
Percentage of Subjects Reporting Headache Pain Freedom
Description
Absence of headache pain. AXS-07 vs Placebo.
Time Frame
Hour 2 following dose administration
Title
Percentage of Subjects With Absence of Most Bothersome Symptom
Description
Absence of most bothersome symptom, defined at the onset of migraine. AXS-07 vs Placebo.
Time Frame
Hour 2 following dose administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Clinical Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Clinical Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
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
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Clinical Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209
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
92399
Country
United States
Facility Name
Clinical Research Site
City
Culver City
State/Province
California
ZIP/Postal Code
90230
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
Oceanside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Clinical Research Site
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Clinical Research Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Clinical Research Site
City
Riverside
State/Province
California
ZIP/Postal Code
92503
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
Santa Monica
State/Province
California
ZIP/Postal Code
90404
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
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Clinical Research Site
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Facility Name
Clinical Research Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Clinical Research Site
City
Fernandina Beach
State/Province
Florida
ZIP/Postal Code
32034
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
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Clinical Research Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
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
Orange City
State/Province
Florida
ZIP/Postal Code
32763
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
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Clinical Research Site
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
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
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
Clinical Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
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
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
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
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Clinical Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
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
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70125
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
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
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Clinical Research Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
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Clinical Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
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United States
Facility Name
Clinical Research Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
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
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Clinical Research Site
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
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
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Clinical Research Site
City
Endwell
State/Province
New York
ZIP/Postal Code
12760
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
New York
State/Province
New York
ZIP/Postal Code
10017
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
Wilmington
State/Province
North Carolina
ZIP/Postal Code
24801
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
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Clinical Research Site
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
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
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
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
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
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
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Clinical Research Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
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
Links:
URL
http://www.axsome.com
Description
Axsome Therapeutics Website

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Maximizing Outcomes in Treating Acute Migraine

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