Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE)

An Open-Label, Multiple-Dose Evaluation of the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05550207

Enrollment

100

Registered

2022-09-22

Start date

2022-08-31

Completion date

2024-11-27

Last updated

2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

Migraine, AXS-07, Meloxicam, Rizatriptan, Oral CGRP inhibitor

Brief summary

This is a multicenter, open-label trial to evaluate the efficacy and safety of AXS-07 in subjects with migraine attacks and prior inadequate response to oral CGRP inhibitors.

Detailed description

Eligible subjects will receive open-label AXS-07 for up to 8 weeks for at-home treatment of their next 4 migraine attacks.

Interventions

DRUGAXS-07 (meloxicam-rizatriptan)

AXS-07 tablets, taken orally for the acute treatment of migraine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Has an established diagnosis of migraine with or without aura * Has experienced an inadequate response to oral CGRP inhibitors for the acute treatment of migraine

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of subjects with headache pain relief	Hour 2 following dose administration	Absence of headache pain and without the use of rescue medication.
Percentage of subjects with absence of the Most Bothersome Symptom	Hour 2 following dose administration	Absence of the most bothersome symptom, defined at the onset of migraine.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026