Clinical trial NCT04163185: Initiating Early Control of Migraine Pain and Associated Symptoms
Official title: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: Migraine
AXS-07
Meloxicam
Rizatriptan
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-14
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 placebo.

This is a randomized, double-blind, single-dose, placebo-controlled trial. Subjects who successfully complete the screening period and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07 or placebo upon the earliest onset of migraine pain.


Eligibility criteria: Key Inclusion Criteria:

• Has an established diagnosis of migraine with or without aura.

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.

Primary outcomes:
measure: Percentage of subjects reporting headache pain freedom
timeFrame: Hour 2
measure: Percentage of subjects with absence of Most Bothersome Symptom
timeFrame: Hour 2
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Site
state: Alabama
city: Birmingham
country: United States
facility: Clinical Research Site
state: Alabama
city: Mobile
country: United States
facility: Clinical Research Site
state: Alabama
city: Colton
country: United States
facility: Clinical Research Site
state: California
city: Encino
country: United States
facility: Clinical Research Site
state: California
city: Los Alamitos
country: United States
facility: Clinical Research Site
state: California
city: Los Angeles
country: United States
facility: Clinical Research Site
state: California
city: Redlands
country: United States
facility: Clinical Research Site
state: California
city: Santa Monica
country: United States
facility: Clinical Research Site
state: California
city: Spring Valley
country: United States
facility: Clinical Research Site
state: California
city: Walnut Creek
country: United States
facility: Clinical Research Site
state: California
city: Hallandale Beach
country: United States
facility: Clinical Research Site
state: Florida
city: Jacksonville
country: United States
facility: Clinical Research Site
state: Florida
city: Lake City
country: United States
facility: Clinical Research Site
state: Florida
city: Lake Worth
country: United States
facility: Clinical Research Site
state: Florida
city: Ocoee
country: United States
facility: Clinical Research Site
state: Florida
city: Orlando
country: United States
facility: Clinical Research Site
state: Florida
city: Ormond Beach
country: United States
facility: Clinical Research Site
state: Florida
city: South Miami
country: United States
facility: Clinical Research Site
state: Florida
city: Sunrise
country: United States
facility: Clinical Research Site
state: Florida
city: Tampa
country: United States
facility: Clinical Research Site
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Site
state: Georgia
city: Evanston
country: United States
facility: Clinical Research Site
state: Illinois
city: Louisville
country: United States
facility: Clinical Research Site
state: Kentucky
city: Boston
country: United States
facility: Clinical Research Site
state: Massachusetts
city: Waltham
country: United States
facility: Clinical Research Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Clinical Research Site
state: Michigan
city: Springfield
country: United States
facility: Clinical Research Site
state: Missouri
city: Albuquerque
country: United States
facility: Clinical Research Site
state: New Mexico
city: Manlius
country: United States
facility: Clinical Research Site
state: New York
city: Williamsville
country: United States
facility: Clinical Research Site
state: New York
city: High Point
country: United States
facility: Clinical Research Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Clinical Research Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Research Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Clinical Research Site
state: South Carolina
city: Memphis
country: United States
facility: Clinical Research Site
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Site
state: Tennessee
city: Austin
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
Study officials:
References: