AbbVie has announced positive topline results from its Phase 3 TEMPLE study, demonstrating that atogepant (QULIPTA®/AQUIPTA®) shows superior tolerability and efficacy compared to topiramate for migraine prevention in adults. The multicenter, randomized, double-blind, head-to-head study evaluated 545 patients with episodic or chronic migraine across 73 sites in Europe, Israel, and Canada.
Primary Endpoint Achievement
The study met its primary endpoint of treatment discontinuation due to adverse events, with atogepant showing significantly fewer discontinuations compared to topiramate. Over the 24-week double-blind treatment period, discontinuation due to adverse events was 12.1% for atogepant versus 29.6% for topiramate, representing a relative risk of 0.41 (95% CI: 0.28, 0.59; p<0.0001).
Superior Clinical Efficacy Across All Endpoints
Atogepant achieved statistical significance across all six secondary endpoints. Most notably, 64.1% of patients on atogepant achieved a ≥50% reduction in mean monthly migraine days during months 4 to 6 of the double-blind treatment period, compared to 39.3% of patients on topiramate (p<0.0001).
"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," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer at AbbVie.
Study Design and Patient Population
The TEMPLE trial enrolled adult patients with a history of four or more migraine days per month. The study was conducted in two distinct periods: an initial 24-week double-blind treatment period that included a 6-week up-titration phase and an 18-week maintenance phase, followed by a 52-week open-label treatment period.
Participants were randomized to receive either atogepant 60 mg once daily or the highest tolerated dose of topiramate ranging from 50 to 100 mg per day. Throughout the study, patient-reported outcomes were regularly collected, and patients were continuously monitored for safety and tolerability through clinical assessments and laboratory tests.
Addressing Significant Unmet Medical Need
Migraine affects approximately 14% of the global population and ranks as the second leading cause of disability worldwide. Despite its prevalence and disabling impact, significant gaps exist in patient care related to preventive treatment standards. Notably, over 50% of people currently using preventive medications still qualify for further preventive treatment, indicating that their current therapies may not provide sufficient relief.
"Far too often, people living with migraine struggle with meeting their treatment goals despite available and accessible preventive options," said Jaclyn Duvall, M.D., neurologist and founder of Headache Specialists of Oklahoma. "The TEMPLE data provide a patient-centered measure of treatment effectiveness by capturing both efficacy and tolerability, representing a meaningful way to evaluate the real-world impact of treatment persistence in migraine prevention."
CGRP Mechanism of Action
Atogepant is a once-daily oral CGRP receptor antagonist specifically developed for the preventive treatment of migraine in adults. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology, and studies have shown that CGRP levels are elevated during migraine attacks.
The adverse event profile of atogepant observed in this active-controlled study was generally consistent with its established safety profile from prior studies. Atogepant is currently approved in 60 countries, marketed as AQUIPTA® in the EU and QULIPTA® in the U.S., Canada, Israel, and Puerto Rico.
Full results from the TEMPLE study will be presented at an upcoming medical meeting, providing additional insights into this head-to-head comparison that could influence clinical practice guidelines for migraine prevention.
