MOMENTUM: Maximizing Outcomes in Treating Acute Migraine
Sponsor
Axsome Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03896009
Collaborator
(none)
1,594
85
4
9.2
18.8
2
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1594 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Mar 4, 2019
Actual Primary Completion Date
:
Dec 10, 2019
Actual Study Completion Date
:
Dec 10, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AXS-07 Taken once upon a qualifying migraine |
Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)
AXS-07 taken once upon onset of a qualifying migraine.
|
| Active Comparator: Meloxicam Taken once upon a qualifying migraine |
Drug: Meloxicam
Meloxicam taken once upon onset of a qualifying migraine.
|
| Active Comparator: Rizatriptan Taken once upon a qualifying migraine |
Drug: Rizatriptan
Rizatriptan taken once upon onset of a qualifying migraine.
|
| Placebo Comparator: Placebo Taken once upon a qualifying migraine |
Drug: Placebo
Placebo taken once upon onset of a qualifying migraine.
|
Outcome Measures
Primary Outcome Measures
- Percentage of subjects reporting headache pain freedom [Hour 2 following dose administration]
Absence of headache pain
- Percentage of subjects with absence of Most Bothersome Symptom [Hour 2 following dose administration]
Absence of most bothersome symptom, defined at the onset of migraine
Secondary Outcome Measures
- Percentage of subjects reporting sustained headache pain freedom [Hours 2 through 24 following dose administration]
Sustained headache pain freedom without use of rescue medication and no relapse of headache pain
- Percentage of subjects reporting headache pain relief [Hour 2 following dose administration]
Mild or no headache pain
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Research Site | Birmingham | Alabama | United States | 35205 |
| 2 | Clinical Research Site | Birmingham | Alabama | United States | 35216 |
| 3 | Clinical Research Site | Mobile | Alabama | United States | 36608 |
| 4 | Clinical Research Site | Phoenix | Arizona | United States | 85004 |
| 5 | Clinical Research Site | Tempe | Arizona | United States | 85283 |
| 6 | Clinical Research Site | Little Rock | Arkansas | United States | 72209 |
| 7 | Clinical Research Site | Canoga Park | California | United States | 91303 |
| 8 | Clinical Research Site | Colton | California | United States | 92399 |
| 9 | Clinical Research Site | Culver City | California | United States | 90230 |
| 10 | Clinical Research Site | Encino | California | United States | 91316 |
| 11 | Clinical Research Site | Los Alamitos | California | United States | 90720 |
| 12 | Clinical Research Site | Los Angeles | California | United States | 90017 |
| 13 | Clinical Research Site | Oceanside | California | United States | 92506 |
| 14 | Clinical Research Site | Pomona | California | United States | 91767 |
| 15 | Clinical Research Site | Redlands | California | United States | 92374 |
| 16 | Clinical Research Site | Riverside | California | United States | 92503 |
| 17 | Clinical Research Site | San Diego | California | United States | 92103 |
| 18 | Clinical Research Site | Santa Monica | California | United States | 90404 |
| 19 | Clinical Research Site | Spring Valley | California | United States | 91978 |
| 20 | Clinical Research Site | Walnut Creek | California | United States | 94598 |
| 21 | Clinical Research Site | Waterbury | Connecticut | United States | 06708 |
| 22 | Clinical Research Site | Clermont | Florida | United States | 34711 |
| 23 | Clinical Research Site | DeLand | Florida | United States | 32720 |
| 24 | Clinical Research Site | Fernandina Beach | Florida | United States | 32034 |
| 25 | Clinical Research Site | Hallandale Beach | Florida | United States | 33009 |
| 26 | Clinical Research Site | Hialeah | Florida | United States | 33012 |
| 27 | Clinical Research Site | Hollywood | Florida | United States | 33024 |
| 28 | Clinical Research Site | Jacksonville | Florida | United States | 32256 |
| 29 | Clinical Research Site | Lake City | Florida | United States | 32055 |
| 30 | Clinical Research Site | Lake Worth | Florida | United States | 33467 |
| 31 | Clinical Research Site | Miami | Florida | United States | 33155 |
| 32 | Clinical Research Site | Ocoee | Florida | United States | 34761 |
| 33 | Clinical Research Site | Orange City | Florida | United States | 32763 |
| 34 | Clinical Research Site | Orlando | Florida | United States | 32801 |
| 35 | Clinical Research Site | Ormond Beach | Florida | United States | 32174 |
| 36 | Clinical Research Site | South Miami | Florida | United States | 33143 |
| 37 | Clinical Research Site | Sunrise | Florida | United States | 33351 |
| 38 | Clinical Research Site | Tampa | Florida | United States | 33634 |
| 39 | Clinical Research Site | Atlanta | Georgia | United States | 30312 |
| 40 | Clinical Research Site | Atlanta | Georgia | United States | 30331 |
| 41 | Clinical Research Site | Stockbridge | Georgia | United States | 30281 |
| 42 | Clinical Research Site | Meridian | Idaho | United States | 83642 |
| 43 | Clinical Research Site | Evanston | Illinois | United States | 60201 |
| 44 | Clinical Research Site | Lenexa | Kansas | United States | 66214 |
| 45 | Clinical Research Site | Lexington | Kentucky | United States | 40509 |
| 46 | Clinical Research Site | Louisville | Kentucky | United States | 40213 |
| 47 | Clinical Research Site | New Orleans | Louisiana | United States | 70125 |
| 48 | Clinical Research Site | Boston | Massachusetts | United States | 02131 |
| 49 | Clinical Research Site | North Dartmouth | Massachusetts | United States | 02747 |
| 50 | Clinical Research Site | Watertown | Massachusetts | United States | 02472 |
| 51 | Clinical Research Site | Ann Arbor | Michigan | United States | 48104 |
| 52 | Clinical Research Site | Minneapolis | Minnesota | United States | 55402 |
| 53 | Clinical Research Site | Kansas City | Missouri | United States | 64114 |
| 54 | Clinical Research Site | Springfield | Missouri | United States | 65810 |
| 55 | Clinical Research Site | Las Vegas | Nevada | United States | 89102 |
| 56 | Clinical Research Site | Berlin | New Jersey | United States | 08009 |
| 57 | Clinical Research Site | Toms River | New Jersey | United States | 08755 |
| 58 | Clinical Research Site | Albuquerque | New Mexico | United States | 87102 |
| 59 | Clinical Research Site | Bronx | New York | United States | 10461 |
| 60 | Clinical Research Site | Endwell | New York | United States | 12760 |
| 61 | Clinical Research Site | Manlius | New York | United States | 13104 |
| 62 | Clinical Research Site | New York | New York | United States | 10017 |
| 63 | Clinical Research Site | Rochester | New York | United States | 14609 |
| 64 | Clinical Research Site | Williamsville | New York | United States | 14221 |
| 65 | Clinical Research Site | High Point | North Carolina | United States | 27262 |
| 66 | Clinical Research Site | Wilmington | North Carolina | United States | 24801 |
| 67 | Clinical Research Site | Cincinnati | Ohio | United States | 45212 |
| 68 | Clinical Research Site | Cleveland | Ohio | United States | 44122 |
| 69 | Clinical Research Site | Dublin | Ohio | United States | 43016 |
| 70 | Clinical Research Site | Oklahoma City | Oklahoma | United States | 73106 |
| 71 | Clinical Research Site | Portland | Oregon | United States | 97214 |
| 72 | Clinical Research Site | Salem | Oregon | United States | 97301 |
| 73 | Clinical Research Site | Philadelphia | Pennsylvania | United States | 19114 |
| 74 | Clinical Research Site | Charleston | South Carolina | United States | 29406 |
| 75 | Clinical Research Site | Mount Pleasant | South Carolina | United States | 29464 |
| 76 | Clinical Research Site | Knoxville | Tennessee | United States | 37920 |
| 77 | Clinical Research Site | Memphis | Tennessee | United States | 38119 |
| 78 | Clinical Research Site | Nashville | Tennessee | United States | 37203 |
| 79 | Clinical Research Site | Austin | Texas | United States | 78731 |
| 80 | Clinical Research Site | San Antonio | Texas | United States | 78229 |
| 81 | Clinical Research Site | Salt Lake City | Utah | United States | 84107 |
| 82 | Clinical Research Site | Charlottesville | Virginia | United States | 22911 |
| 83 | Clinical Research Site | Norfolk | Virginia | United States | 23507 |
| 84 | Clinical Research Site | Bellevue | Washington | United States | 98007 |
| 85 | Clinical Research Site | Seattle | Washington | United States | 98105 |
Sponsors and Collaborators
- Axsome Therapeutics, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT03896009
Other Study ID Numbers:
- AXS-07-301
First Posted:
Mar 29, 2019
Last Update Posted:
Apr 26, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Axsome Therapeutics, Inc.
Additional relevant MeSH terms: