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Initiating Early Control of Migraine Pain and Associated Symptoms

NCT04163185 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2026-01-28

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 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.

Conditions

Interventions

DRUG

AXS-07 (MoSEIC meloxicam and rizatriptan)

AXS-07 tablet taken once upon the earliest onset of migraine pain.

DRUG

Placebo

Placebo tablet taken once upon the earliest onset of migraine pain.

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
2019-10-08
Primary Completion
2020-03-16
Completion
2020-03-23
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 NCT04163185 on ClinicalTrials.gov