CompletedPhase 3

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)

United States100 participantsStarted 2022-08-31

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of subjects with headache pain relief

Timeframe: Hour 2 following dose administration

Percentage of subjects with absence of the Most Bothersome Symptom

Timeframe: Hour 2 following dose administration

Trial details

NCT IDNCT05550207

SponsorAxsome Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-27

View on ClinicalTrials.gov More Migraine trials