AbbVie has announced that its Phase III TEMPLE study, which compared the oral calcitonin gene-related peptide (CGRP) receptor antagonist, atogepant, to topiramate’s highest tolerated dose for migraine in adults, has met its primary endpoint.
This double-blind, randomised, head-to-head trial showed that the therapy had fewer treatment discontinuations due to adverse events (AEs) than topiramate.
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Those who have a history of four or more migraine days/month are involved in the trial.
A total of 545 subjects with episodic or chronic migraine, who are aged 18 and above, were included in the trial across 73 sites in Canada, Europe, and Israel.
It consisted of two periods: a 24-week double-blind treatment period with a six-week up-titration phase and an 18-week maintenance phase, followed by an open-label treatment period for 52 weeks.
Over the course of the 24-week double-blind treatment period, 12.1% of subjects on atogepant discontinued due to AEs, compared to 29.6% on topiramate.
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By GlobalDataAll six secondary goals were also met in the trial. Notably, 64.1% of subjects taking the therapy achieved a reduction of 50% or more in mean monthly migraine days (MMD) during the four to six months of the treatment period, against 39.3% of those on topiramate.
During the study, the outcomes reported by subjects were gathered via an electronic diary, and their tolerability and safety were continuously monitored through clinical evaluations and laboratory tests.
AbbVie research and development executive vice-president and chief scientific officer Roopal Thakkar said: “These TEMPLE data affirm recommendations from the American Headache Society and International Headache Society, highlighting the role of CGRP pathway inhibitors as first-line preventive treatment options for migraine.
“This study demonstrates our commitment to improving treatment options and advancing care standards for people living with this debilitating disease.”
The once-daily therapy is marketed under the names Aquipta in the EU and Qulipta in Canada, the US, Israel, and Puerto Rico.
It gained approval for use in 60 nations and has demonstrated potential in preventing both episodic and chronic migraine.
In January 2024, AbbVie reported positive data from its Phase II trial of lutikizumab (ABT-981).
