Key Takeaways
- Qulipta/Aquipta shows superior tolerability: In the Phase III TEMPLE trial, only 12.1% of patients on Qulipta (atogepant) for the treatment of migraine headaches discontinued therapy due to adverse events (AEs) compared to 29.6% on topiramate.
- Greater efficacy in migraine reduction: Results found that 64.1% of patients on Qulipta/Aquipta achieved a ≥50% reduction in monthly migraine days versus 39.3% on topiramate (p<0.0001).
- CGRP pathway validated as first-line: Findings reinforce CGRP inhibitors, such as Qulipta, as preferred preventive treatments for migraine in line with major headache society recommendations.
Results from the Phase III TEMPLE trial show that AbbVie’s Qulipta (atogepant) resulted in significantly fewer treatment discontinuations due to adverse events (AEs) compared to topiramate in adults experiencing four or more migraine days per month. According to AbbVie, the treatment also demonstrated superiority across all six of the trial’s secondary endpoints.1
How Does Atogepant Compare to Topiramate for Migraine Prevention?
"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, MD, EVP, research and development, chief scientific officer, AbbVie, in a press release. "This study demonstrates our commitment to improving treatment options and advancing care standards for people living with this debilitating disease."
TEMPLEStudy Design and Structure
- The multicenter, randomized, double-blind, active-controlled TEMPLE trial evaluated the tolerability, safety, and efficacy of Qulipta compared to topiramate in 545 adult patients.
- The study was conducted in two main phases. In the first—a 24-week double-blind period—participants were randomly assigned to receive either Qulipta (60 mg once daily) or their highest tolerated dose of topiramate (between 50 and 100 mg/day). This phase included a six-week titration period to gradually reach the target dose, followed by 18 weeks of maintenance treatment.
- Participants who met eligibility criteria then entered a 52-week open-label extension, during which all received Qulipta (60 mg once daily).
- The primary endpoint was the proportion of patients who discontinued treatment due to AEs during the 24-week double-blind phase.
Clinical Outcomes and Efficacy
- Results showed that 12.1% of patients in the Qulipta arm discontinued treatment due to AEs compared to 29.6% in the topiramate group.
- Additionally, 64.1% of patients receiving Qulipta achieved a ≥50% reduction in monthly migraine days during months four to six, versus 39.3% on topiramate (p<0.0001).
- AbbVie stated that the AE profile of the treatment was consistent with established safety profiles of previous studies.1
Full results from the trial are expected to be presented at an upcoming medical meeting.
Migraine Burden and Patient Impact
According to a study by the American Migraine Foundation, migraine occurs in approximately 12% of people over 12 years of age in the United States. It is estimated to be three times more common in woman than in men.
Rates decrease in those aged 60 years and older, making it most common in middle-aged people. One percent of people in the United States also deal with chronic migraine, equal to 1.5 million women and more than more than half a million men.
Approximately half of patients experience nausea with migraines.2 Migraines typically begin during puberty and children typically experience shorter migraines, while abdominal symptoms are usually more prominent.
According to the World Health Organization, headache disorders affect approximately 40% of the global population. In 2019, headache disorders were ranked third overall in accounting for overall neurological disease burden as measured by age-standardized disability-adjusted life years, after stroke and dementia.3
Expert Commentary on Treatment Value of Qulipta
"Far too often, people living with migraine struggle with meeting their treatment goals despite available and accessible preventive options," said Jaclyn Duvall, MD, 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."
References
1. AbbVie Announces New Data Demonstrating Atogepant (QULIPTA® / AQUIPTA®) Achieves Superiority Across All Endpoints in Phase 3 Head-to-Head Study Compared to Topiramate for Migraine Prevention. AbbVie. June 18, 2025. Accessed June 18, 2025. https://news.abbvie.com/2025-06-18-AbbVie-Announces-New-Data-Demonstrating-Atogepant-QULIPTA-R-AQUIPTA-R-Achieves-Superiority-Across-All-Endpoints-in-Phase-3-Head-to-Head-Study-Compared-to-Topiramate-for-Migraine-Prevention
2. Understanding Research: What is the American Migraine Prevalence and Prevention (AMPP) Study and What We Have Learned From It? AMPP. Accessed June 18, 2025. https://americanmigrainefoundation.org/resource-library/ampp/
3. Migraine and other headache disorders. WHO. Accessed June 18, 2025. https://www.who.int/news-room/fact-sheets/detail/headache-disorders
