Clinical trial

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

Name

AXS-07-304

Description

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.

Trial arms

Trial start

2022-08-31

Estimated PCD

2024-12-01

Trial end

2024-12-01

Status

Recruiting

Phase

Early phase I

Treatment

AXS-07 (meloxicam-rizatriptan)

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

Arms:

AXS-07 (meloxicam-rizatriptan)

Size

100

Primary endpoint

Percentage of subjects with headache pain relief

Hour 2 following dose administration

Percentage of subjects with absence of the Most Bothersome Symptom

Hour 2 following dose administration

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2024-04-26

1 organization

1 product

1 indication

Organization

Axsome Therapeutics

Product

AXS-07

Indication

Migraine