Axsome Therapeutics
has enrolled the first patient in the EMERGE trial of its lead candidate AXS-07 for the acute treatment of migraine.
EMERGE study is a Phase 3 trial to assess the efficacy and safety of AXS-07 in the acute treatment of migraine in patients with a prior inadequate response to an oral Calcitonin Gene-Related Peptide (CGRP) inhibitor.
The trial will enrol upto 100 patients experiencing migraine attacks and will be treated with AXS-07 for up to eight weeks.
The two co-primary endpoints will be pain relief and absence of the most bothersome symptom two hours after dosing.
The study is being conducted to further demonstrate the clinical profile of AXS-07 and is not a regulatory requirement.
Migraine is distinguished by recurrent attacks of pulsating, often severe and disabling head pain associated with nausea, and sensitivity to light and or sound.
Axsome Therapeutics is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options.
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