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NCT04163185 Clinical Trial

Initiating Early Control of Migraine Pain and Associated Symptoms

Migraine Clinical Trial

— INTERCEPT  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04163185
Other study ID # AXS-07-303
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 8, 2019
Est. completion date March 23, 2020

Study information
Verified date April 2021
Source Axsome Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 302
Est. completion date March 23, 2020
Est. primary completion date March 23, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AXS-07 (MoSEIC meloxicam and rizatriptan)
AXS-07 tablet taken once upon the earliest onset of migraine pain.
• Placebo
Placebo tablet taken once upon the earliest onset of migraine pain.

Locations
Country Name City State
United States Clinical Research Site Albuquerque New Mexico
United States Clinical Research Site Ann Arbor Michigan
United States Clinical Research Site Austin Texas
United States Clinical Research Site Birmingham Alabama
United States Clinical Research Site Birmingham Alabama
United States Clinical Research Site Boston Massachusetts
United States Clinical Research Site Charleston South Carolina
United States Clinical Research Site Charlottesville Virginia
United States Clinical Research Site Colton California
United States Clinical Research Site Encino California
United States Clinical Research Site Evanston Illinois
United States Clinical Research Site Hallandale Beach Florida
United States Clinical Research Site High Point North Carolina
United States Clinical Research Site Jacksonville Florida
United States Clinical Research Site Lake City Florida
United States Clinical Research Site Lake Worth Florida
United States Clinical Research Site Los Alamitos California
United States Clinical Research Site Los Angeles California
United States Clinical Research Site Louisville Kentucky
United States Clinical Research Site Manlius New York
United States Clinical Research Site Memphis Tennessee
United States Clinical Research Site Mobile Alabama
United States Clinical Research Site Mount Pleasant South Carolina
United States Clinical Research Site Nashville Tennessee
United States Clinical Research Site Ocoee Florida
United States Clinical Research Site Oklahoma City Oklahoma
United States Clinical Research Site Orlando Florida
United States Clinical Research Site Ormond Beach Florida
United States Clinical Research Site Philadelphia Pennsylvania
United States Clinical Research Site Redlands California
United States Clinical Research Site Salt Lake City Utah
United States Clinical Research Site Santa Monica California
United States Clinical Research Site South Miami Florida
United States Clinical Research Site Spring Valley California
United States Clinical Research Site Springfield Missouri
United States Clinical Research Site Stockbridge Georgia
United States Clinical Research Site Sunrise Florida
United States Clinical Research Site Tampa Florida
United States Clinical Research Site Walnut Creek California
United States Clinical Research Site Waltham Massachusetts
United States Clinical Research Site Williamsville New York

Sponsors (1)
Lead Sponsor Collaborator
Axsome Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of subjects reporting headache pain freedom Absence of headache pain Hour 2
Primary Percentage of subjects with absence of Most Bothersome Symptom Absence of Most Bothersome Symptom, defined at the onset of migraine Hour 2
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