Clinical trial NCT04068051: Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)
Official title: An Open-Label, Long-Term Study to Assess the Safety and Efficacy of AXS-07 (MoSEIC™ Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: Axsome
AXS-07
MoSEIC™ meloxicam
rizatriptan
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 706
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: MOVEMENT (Multimechanistic Treatment over Time of Migraine Symptoms) is a Phase 3 study to evaluate the long-term safety of chronic intermittent use of AXS-07 and to assess the effect of AXS-07 on migraine symptoms following repeated treatment of migraine attacks.

Detailed description: This study is a Phase 3, multicenter, open-label, trial to evaluate the long-term safety and efficacy of intermittent chronic dosing with AXS-07 in subjects with migraine attacks. Eligible subjects will take AXS-07 following the onset of a migraine. Subjects will be treated for up to 12 months.

Eligibility criteria: Inclusion Criteria:

* Has participated in a prior study with AXS-07 for the treatment of migraine

Exclusion Criteria:

* Has previously received any investigational drug or device or investigational therapy within 30 days before Screening, other than AXS-07
* Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study

Primary outcomes:
measure: Long-term Safety of Chronic Intermittent Use of AXS-07
timeFrame: Up to 12 months
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: Phoenix
country: United States
facility: Clinical Research Site
state: Arizona
city: Canoga Park
country: United States
facility: Clinical Research Site
state: California
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: Los Angeles
country: United States
facility: Clinical Research Site
state: California
city: San Diego
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: Miami
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: 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: North Dartmouth
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: Minneapolis
country: United States
facility: Clinical Research Site
state: Minnesota
city: Springfield
country: United States
facility: Clinical Research Site
state: Missouri
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: Manlius
country: United States
facility: Clinical Research Site
state: New York
city: Rochester
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: Cincinnati
country: United States
facility: Clinical Research Site
state: Ohio
city: Columbus
country: United States
facility: Clinical Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Clinical Research Site
state: Oklahoma
city: Portland
country: United States
facility: Clinical Research Site
state: Oregon
city: Salem
country: United States
facility: Clinical Research Site
state: Oregon
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: Knoxville
country: United States
facility: Clinical Research Site
state: Tennessee
city: Memphis
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
city: Seattle
country: United States
facility: Clinical Research Site
state: Washington
Study officials:
References: