Maximizing Outcomes in Treating Acute Migraine

• Status: Completed
• Trial end date: 2019-12-10
• Target enrollment: 0
• Participant gender: All

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 meloxicam, rizatriptan, and placebo for the treatment of a migraine attack.

This is a randomized, double-blind, 4-arm, parallel group, single-dose, placebo-controlled trial. Subjects who successfully complete screening and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07, meloxicam, rizatriptan, or placebo upon the occurrence of a qualifying migraine.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axsome Therapeutics, Inc.
• Treatments: Meloxicam; Rizatriptan

Criteria

Key Inclusion Criteria:

• Has an established diagnosis of migraine with or without aura.

• Has experienced an inadequate response to prior acute treatments.

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.