AbbVie TEMPLE Study Demonstrates Superior Tolerability and Efficacy of Atogepant (QULIPTA®) in Head-to-Head Migraine Prevention Trial
AbbVie TEMPLE Study Demonstrates Superior Tolerability and Efficacy of Atogepant (QULIPTA®) in Head-to-Head Migraine Prevention Trial |
| [29-October-2026] |
MONTREAL, Oct. 29, 2026 /CNW/ -- 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 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 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 About AbbVie in Migraine About AbbVie References
SOURCE AbbVie Canada | ||
Company Codes: NYSE:ABBV |
