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)

Axsome Therapeutics

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: AXS-07 (meloxicam-rizatriptan)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05550207

AXS-07-304

Details and patient eligibility

About

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.

Full description

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

AXS-07 (meloxicam-rizatriptan)

Experimental group

Description:

Up to 8 weeks

Treatment:

Drug: AXS-07 (meloxicam-rizatriptan)