AbbVie has reported positive results from its Phase III ELEVATE trial of atogepant, an orally administered, CGRP receptor antagonist, for the preventive episodic migraine treatment in adults.
The international, double-blind, randomised, placebo-controlled trial has been designed to evaluate the tolerability, safety and efficacy, of 60mg once-daily (QD) atogepant compared with a placebo in subjects with episodic migraine who had failed two to four classes of oral preventive medications earlier.
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Change from baseline in mean monthly migraine days (MMDs) across 12 weeks was the primary endpoint of the trial, which enrolled a total of 309 participants.
Secondary endpoints included achievement of more than 50% reduction in MMDs, change from baseline in MMDs and in acute medication use days across 12 weeks.
Besides meeting all primary and secondary endpoints, the ELEVATE trial demonstrated a reduction in MMDs for episodic migraine patients taking 60mg of atogepant against a placebo.
AbbVie neuroscience development vice-president Dawn Carlson said: “We understand that people living with migraine endure a chronic neurological disease and we are dedicated to providing them the best chance to live a life with less frequent migraines.”
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By GlobalDataAdult subjects, who received the atogepant 60mg QD, experienced a decrease of 4.20 days in their MMDs across the treatment period for 12 weeks.
In the trial, 56% of the enrolled subjects had failed two classes of oral migraine preventive medications and 44% failed three or more classes, earlier.
They discontinued those medications due to efficacy or tolerability concerns.
Atogepant was found to be well tolerated and the safety results were in line with its known profile.
Last month, AbbVie reported topline data from the Phase II SLEek trial of upadacitinib in patients with moderately to severely active systemic lupus erythematosus.
