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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)

Primary Purpose

Migraine

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AXS-07 (meloxicam-rizatriptan)
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, Oral CGRP inhibitor

Eligibility Criteria

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

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

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AXS-07 (meloxicam-rizatriptan)

Arm Description

Up to 8 weeks

Outcomes

Primary Outcome Measures

Percentage of subjects with headache pain relief
Absence of headache pain and without the use of rescue medication.
Percentage of subjects with absence of the Most Bothersome Symptom
Absence of the most bothersome symptom, defined at the onset of migraine.

Secondary Outcome Measures

Full Information

First Posted
September 19, 2022
Last Updated
September 21, 2023
Sponsor
Axsome Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05550207
Brief Title
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)
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

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

5. 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.
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.

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, Oral CGRP inhibitor

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
AXS-07 (meloxicam-rizatriptan)
Arm Type
Experimental
Arm Description
Up to 8 weeks
Intervention Type
Drug
Intervention Name(s)
AXS-07 (meloxicam-rizatriptan)
Intervention Description
AXS-07 tablets, taken orally for the acute treatment of migraine
Primary Outcome Measure Information:
Title
Percentage of subjects with headache pain relief
Description
Absence of headache pain and without the use of rescue medication.
Time Frame
Hour 2 following dose administration
Title
Percentage of subjects with absence of the Most Bothersome Symptom
Description
Absence of the most bothersome symptom, defined at the onset of migraine.
Time Frame
Hour 2 following dose administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director
Phone
+1 (212) 332-5061
Email
cstreicher@axsome.com
Facility Information:
Facility Name
Clinical Research Site
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
31274
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Site
City
McLean
State/Province
Virginia
ZIP/Postal Code
22101
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.axsome.com
Description
Axsome Therapeutics Website

Learn more about this trial

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)

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