Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE)
Sponsor
Axsome Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05550207
Collaborator
(none)
100
19
1
15
5.3
0.4
Study Details
Study Description
Brief Summary
This is a multicenter, open-label trial to evaluate the efficacy and safety of AXS-07 in subjects with migraine attacks and prior inadequate response to oral CGRP inhibitors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Eligible subjects will receive open-label AXS-07 for up to 8 weeks for at-home treatment of their next 4 migraine attacks.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multiple-Dose Evaluation of the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor
Actual Study Start Date
:
Aug 31, 2022
Anticipated Primary Completion Date
:
Dec 1, 2023
Anticipated Study Completion Date
:
Dec 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AXS-07 (meloxicam-rizatriptan) Up to 8 weeks |
Drug: AXS-07 (meloxicam-rizatriptan)
AXS-07 tablets, taken orally for the acute treatment of migraine
|
Outcome Measures
Primary Outcome Measures
- Percentage of subjects with headache pain relief [Hour 2 following dose administration]
Absence of headache pain and without the use of rescue medication.
- Percentage of subjects with absence of the Most Bothersome Symptom [Hour 2 following dose administration]
Absence of the most bothersome symptom, defined at the onset of migraine.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Has an established diagnosis of migraine with or without aura
-
Has experienced an inadequate response to oral CGRP inhibitors for the acute treatment of migraine
Exclusion Criteria:
-
Pregnant, breastfeeding, or planning to become pregnant during the study
-
Has previously received any investigational drug or device or investigational therapy within 30 days before Screening
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Research Site | Colton | California | United States | 92324 |
| 2 | Clinical Research Site | Fullerton | California | United States | 92835 |
| 3 | Clinical Research Site | La Jolla | California | United States | 92037 |
| 4 | Clinical Research Site | Stamford | Connecticut | United States | 06905 |
| 5 | Clinical Research Site | DeLand | Florida | United States | 32720 |
| 6 | Clinical Research Site | Hallandale Beach | Florida | United States | 33009 |
| 7 | Clinical Research Site | Ormond Beach | Florida | United States | 31274 |
| 8 | Clinical Research Site | Oviedo | Florida | United States | 32765 |
| 9 | Clinical Research Site | Sunrise | Florida | United States | 33351 |
| 10 | Clinical Research Site | Boston | Massachusetts | United States | 02131 |
| 11 | Clinical Research Site | North Dartmouth | Massachusetts | United States | 02747 |
| 12 | Clinical Research Site | Albuquerque | New Mexico | United States | 87102 |
| 13 | Clinical Research Site | Williamsville | New York | United States | 14221 |
| 14 | Clinical Research Site | High Point | North Carolina | United States | 27262 |
| 15 | Clinical Research Site | Charleston | South Carolina | United States | 29406 |
| 16 | Clinical Research Site | Knoxville | Tennessee | United States | 37909 |
| 17 | Clinical Research Site | Nashville | Tennessee | United States | 37203 |
| 18 | Clinical Research Site | Cypress | Texas | United States | 77429 |
| 19 | Clinical Research Site | Charlottesville | Virginia | United States | 22911 |
Sponsors and Collaborators
- Axsome Therapeutics, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT05550207
Other Study ID Numbers:
- AXS-07-304
First Posted:
Sep 22, 2022
Last Update Posted:
Sep 22, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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: