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Maximizing Outcomes in Treating Acute Migraine

NCT03896009 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1594

Last updated 2023-08-24

Study results available
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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 meloxicam, rizatriptan, and placebo for the treatment of a migraine attack.

This is a randomized, double-blind, 4-arm, parallel group, single-dose, placebo-controlled trial. Subjects who successfully complete screening and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07, meloxicam, rizatriptan, or placebo upon the occurrence of a qualifying migraine.

Conditions

Interventions

DRUG

AXS-07 (MoSEIC meloxicam and rizatriptan)

AXS-07 taken once upon onset of a qualifying migraine.

DRUG

Meloxicam

Meloxicam taken once upon onset of a qualifying migraine.

DRUG

Rizatriptan

Rizatriptan taken once upon onset of a qualifying migraine.

DRUG

Placebo

Placebo taken once upon onset of a qualifying migraine.

Sponsors & Collaborators

  • Axsome Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-04
Primary Completion
2019-12-10
Completion
2019-12-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03896009 on ClinicalTrials.gov