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- Phase 3 TEMPLE study evaluated the tolerability, safety and efficacy of atogepant (QULIPTA®) compared with topiramate for the preventive treatment of migraine in adults with a history of four or more migraine days per month.1
- Atogepant (QULIPTA®) demonstrated superior efficacy across key clinical and functional outcomes, including reductions in monthly migraine days and improvements in headache-related disability, daily functioning and cognitive function.1
- 25% of Canadian households are impacted by migraine.2
AbbVie (NYSE: ABBV) announced the publication of results from the Phase 3 TEMPLE study in The Lancet Neurology. The randomized, double-blind, head-to-head study evaluated the tolerability, safety and efficacy of atogepant (QULIPTA®) 60 mg, once daily, compared with the highest tolerated dose of topiramate (50 mg, 75 mg or 100 mg per day) for the preventive treatment of migraine in adults.1
The results of the TEMPLE study demonstrated that atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, achieved superior tolerability and efficacy compared with topiramate, a medication also approved for migraine prevention.
"Migraine is a complex neurological disease that affects more than five million Canadians, yet it remains underdiagnosed and undertreated. Patients come to my clinic seeking treatment options, and they fear side effects, which often they have experienced," said Dr. Elizabeth Leroux, Headache Neurologist, MD, FRCPC. "The TEMPLE phase 3 trial provides relevant clinical evidence that any clinician treating migraine patients should read."
Atogepant achieved the primary outcome measures of the TEMPLE study, assessing the proportion of participants who discontinued treatment due to treatment-emergent adverse events during the 24-week double-blind treatment period, and demonstrated superior tolerability when compared to topiramate.1 Treatment discontinuation due to adverse events was significantly lower among study participants receiving atogepant, at 12%, compared with 30% among those receiving topiramate (RR: 0.4 (0.3 to 0.6); p value: <0.0001).
Secondary endpoints were also met and atogepant demonstrated superior efficacy across clinical and functional outcomes.1 Sixty-four percent of participants receiving atogepant achieved at least a 50% reduction in mean monthly migraine days, compared with 39% receiving topiramate (RR: 1.6 (1.4 to 2.0); p value: <0.0001). During months 4 to 6 of the double-blind treatment period, participants treated with atogepant experienced an average reduction of 6.3 monthly migraine days from baseline, compared with 4.5 days among those receiving topiramate (p value: <0.0001). In addition, atogepant demonstrated statistically significant improvements over topiramate in headache-related disability, migraine-specific quality of life, overall patient-reported improvement and cognitive functioning. For further details, please refer to the full publication in The Lancet Neurology.
"Migraine is more than a headache. It's a debilitating neurological disease that disrupts workdays and puts precious moments with loved ones on hold for millions of Canadians," said Tanu Misra, Vice President and General Manager of AbbVie Canada. "The TEMPLE study reflects our commitment to changing that reality through research and innovation, providing evidence to help patients and healthcare providers have informed conversations about preventive treatment. Our goal is simple: help people with migraine reclaim the moments that matter most."
About Migraine3
Migraine is a complex neurological disease with recurrent attacks that lasts 4-72 hours. It can be defined by symptoms such as moderate to severe pain intensity, nausea, vomiting, photophobia and phonophobia. An estimated 5 million Canadians are impacted by migraine. Episodic migraine is characterized as having fewer than 15 headache days per month, while chronic migraine is characterized by 15 or more headache days per month for more than three months, of which at least eight days per month have features of migraine.
Migraine diagnoses are based on established clinical criteria and should be made by a qualified healthcare professional. The descriptions above are not intended to represent the full diagnostic criteria for episodic or chronic migraine.
About the TEMPLE Study1
TEMPLE was a Phase 3, multicentre, randomized, double-dummy, active-controlled study evaluating the tolerability, safety and efficacy of QULIPTA® (atogepant) 60 mg once daily compared with the highest tolerated dose of topiramate—50 mg, 75 mg or 100 mg per day. The study enrolled 545 adults with episodic or chronic migraine across 73 sites in 12 countries, including three in Canada. Participants had a history of migraine and experienced at least four migraine days per month.
The study included a 24-week double-blind treatment period, consisting of a six-week topiramate up-titration period followed by an 18-week maintenance phase. Participants who were eligible could then enter a 52-week open-label treatment period in which they received QULIPTA (atogepant). The publication reports results from the completed double-blind period; findings from the open-label period have not yet been published.
The primary endpoint was treatment discontinuation due to adverse events during the double-blind period. Secondary endpoints included the proportion of participants achieving at least a 50% reduction in mean monthly migraine days, changes in monthly migraine days, headache-related disability, migraine-specific quality of life, patient-reported overall improvement and cognitive functioning.
More information on the TEMPLE trial can be found on www.clinicaltrials.gov (NCT05748483).
About QULIPTA® (atogepant)3
QULIPTA® (atogepant) is the first and only oral, small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for the preventive treatment of episodic and chronic migraine. QULIPTA is an orally administered, small-molecule, selective calcitonin gene-related peptide (CGRP) receptor antagonist that blocks the binding of the CGRP to its receptor. CGRP is a neuropeptide that may play a role in migraine pathophysiology. For important safety information, please consult the QULIPTA® Product Monograph.
About AbbVie in Migraine
At AbbVie, we are committed to empowering people living with migraine disease. We advance science that enables healthcare providers to care for people impacted across the spectrum of migraine. Through education and partnerships with the migraine community, we strive to help those with migraine navigate barriers to care, access effective treatments, and reduce the impact of migraine on their lives.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow AbbVie in Canada on LinkedIn, Instagram, and YouTube.
References
- Reuter U, Van Dycke A, Versijpt J, et al. Tolerability, safety, and efficacy of atogepant versus topiramate in adults with migraine (TEMPLE): a randomised, head-to-head, phase 3b trial. Lancet Neurol. Published online July 23, 2026. doi:10.1016/S1474-4422(26)00214-0.
- Migraine Canada. How Many People Have Headaches? Available at: https://migrainecanada.org/how-many-people-have-headaches/
- AbbVie Canada. QULIPTA® (atogepant) Now Publicly Reimbursed in Quebec for Chronic Migraine and CGRP Class Review Published. September 25, 2025. Available at: https://www.newswire.ca/news-releases/qulipta-r-atogepant-now-publicly-reimbursed-in-quebec-for-chronic-migraine-and-cgrp-class-review-published-871479074.html
- AbbVie Inc. QULIPTA® (atogepant) tablets, for oral use: Full Prescribing Information. Revised September 2025. Available at: https://www.rxabbvie.com/pdf/qulipta_pi.pdf
SOURCE AbbVie Canada
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