Clinical trial NCT05550207: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: Migraine
AXS-07
Meloxicam
Rizatriptan
Oral CGRP inhibitor
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of subjects with headache pain relief
timeFrame: Hour 2 following dose administration
measure: Percentage of subjects with absence of the Most Bothersome Symptom
timeFrame: Hour 2 following dose administration
Secondary outcomes:
Other outcomes:
Locations:
city: Colton
country: United States
facility: Clinical Research Site
state: California
city: Fullerton
country: United States
facility: Clinical Research Site
state: California
city: La Jolla
country: United States
facility: Clinical Research Site
state: California
city: Los Angeles
country: United States
facility: Clinical Research Site
state: California
city: Sherman Oaks
country: United States
facility: Clinical Research Site
state: California
city: Stamford
country: United States
facility: Clinical Research Site
state: Connecticut
city: DeLand
country: United States
facility: Clinical Research Site
state: Florida
city: Hallandale Beach
country: United States
facility: Clinical Research Site
state: Florida
city: Hollywood
country: United States
facility: Clinical Research Site
state: Florida
city: Miami
country: United States
facility: Clinical Research Site
state: Florida
city: Ormond Beach
country: United States
facility: Clinical Research Site
state: Florida
city: Oviedo
country: United States
facility: Clinical Research Site
state: Florida
city: Pensacola
country: United States
facility: Clinical Research Site
state: Florida
city: Winter Park
country: United States
facility: Clinical Research Site
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Site
state: Georgia
city: Avon
country: United States
facility: Clinical Research Site
state: Indiana
city: Boston
country: United States
facility: Clinical Research Site
state: Massachusetts
city: North Dartmouth
country: United States
facility: Clinical Research Site
state: Massachusetts
city: Las Vegas
country: United States
facility: Clinical Research Site
state: Nevada
city: Albuquerque
country: United States
facility: Clinical Research Site
state: New Mexico
city: Bronx
country: United States
facility: Clinical Research Site
state: New York
city: Williamsville
country: United States
facility: Clinical Research Site
state: New York
city: Philadelphia
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Research Site
state: South Carolina
city: Knoxville
country: United States
facility: Clinical Research Site
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Site
state: Tennessee
city: Cypress
country: United States
facility: Clinical Research Site
state: Texas
city: Sugar Land
country: United States
facility: Clinical Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Clinical Research Site
state: Utah
city: Charlottesville
country: United States
facility: Clinical Research Site
state: Virginia
city: McLean
country: United States
facility: Clinical Research Site
state: Virginia
Study officials:
References: