CompletedPhase 3

Initiating Early Control of Migraine Pain and Associated Symptoms

United States302 participantsStarted 2019-10-08

Plain-language summary

AXS-07 is an oral, investigational medicine consisting of MoSEIC meloxicam and rizatriptan, which is being developed for the acute treatment of migraine with or without aura in adults. AXS-07 tablets are formulated to provide an enhanced rate of absorption of meloxicam. This study is designed to evaluate the efficacy and safety of AXS-07 compared to placebo. This is a randomized, double-blind, single-dose, placebo-controlled trial. Subjects who successfully complete the screening period and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07 or placebo upon the earliest onset of migraine pain.

Who can participate

Age range18 Years – 65 Years

SexALL

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

Key Inclusion Criteria: • Has an established diagnosis of migraine with or without aura. Key Exclusion Criteria: * Has previously received any investigational drug or device or investigational therapy within 30 days before Screening. * Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.

What they're measuring

Percentage of Subjects Achieving Headache Pain Freedom at Hour 2

Timeframe: Hour 2

Percentage of Subjects With Absence of Most Bothersome Symptom at Hour 2

Timeframe: Hour 2

Trial details

NCT IDNCT04163185

SponsorAxsome Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-03-16

Results submitted2023-03-18

View on ClinicalTrials.gov More Migraine trials