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Clinical Trials/NCT05550207
NCT05550207CompletedPhase 3

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

Axsome Therapeutics, Inc.1 site in 1 country100 target enrollmentStarted: August 31, 2022Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Percentage of subjects with headache pain relief

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

AXS-07 (meloxicam-rizatriptan)

Experimental

Up to 8 weeks

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

Outcomes

Primary Outcomes

Percentage of subjects with headache pain relief

Time Frame: 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

Time Frame: Hour 2 following dose administration

Absence of the most bothersome symptom, defined at the onset of migraine.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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