Data From Phase III Extension Trial Show Long-Term Safety, Efficacy of Qulipta in Migraine Prevention


Multicenter, open-label, 156-week extension trial finds that Qulipta (atogepant) reduced migraine days and acute medication use in patients with chronic or episodic migraine.

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Results from an interim analysis of an ongoing Phase III trial demonstrated the long-term safety and efficacy of AbbVie’s Qulipta (atogepant) in reducing migraine days in patients with chronic or episodic migraine.1 Interim data from Study 3101-312-002 (NCT04686136), a multicenter, open-label, 156-week extension trial, found that the long-term safety of Qulipta was consistent with the known safety profile of the drug in patients chronic and episodic migraine, while also showing improvements in key efficacy outcomes, such as lowering monthly acute medication use days.

"Migraine is a debilitating neurological disease that can have a significant impact on day-to-day life," lead study author Sait Ashina, MD, assistant professor of neurology and anesthesia at Harvard Medical School, director of the Comprehensive Headache Center at Beth Israel Deaconess Medical Center in Boston, said in a press release. "As the first report of one-year atogepant data in patients with chronic migraine, this builds on the long-term observed safety and efficacy in the episodic migraine population and demonstrates atogepant's ability to reduce migraine days and acute medication use across the spectrum of the disease."1

Qulipta is an oral calcitonin gene-related peptide (CGRP) receptor antagonist approved by the FDA in 2021 for patients with episodic migraines based on data from a clinical program that included approximately 2000 patients with episodic migraine.2 In April 2023, the FDA approved an expanded indication for Qulipta for the preventive treatment of chronic migraine in adults, making it the first and only oral CGRP receptor antagonist indicated to prevent episodic and chronic migraine.3

The primary objective of Study 3101-312-002 is to analyze Qulipta’s safety and tolerability among participants administered ≥1 dose of study intervention in the extension study (N = 595). The drug’s efficacy was analyzed by eDiary at weeks 13-16, 29-32, and 45-48, with pre-specified endpoints that included change from baseline in monthly migraine days, monthly headache days, monthly acute medication use days, and proportion of individuals who experienced a ≥ 50% improvement in monthly migraine days.

Investigators found that patients administered Qulipta experienced an improvement in monthly migraine days by an average of 8.5 days at weeks 13-16, which was consistent across 48 weeks. There were comparable improvements in monthly headache days and monthly acute medication use days as well. Further, 70% of participants achieved a ≥50% decrease in monthly migraine days at weeks 13-16, which was consistent across 48 weeks of open-label treatment.

In terms of safety, the findings were consistent with the known safety profile of Qulipta at a dose of 60 mg, with no new safety signals reported. The most frequently reported adverse events associated with Qulipta (≥5%) were COVID-19 (28.7%), nasopharyngitis (10.9%), and constipation (8.2%).

"We understand that migraine is a complex disease and AbbVie is steadfast in our commitment to alleviating the considerable burden facing migraine patients," Dawn Carlson, vice president, neuroscience development, AbbVie, said in a press release. "Patients should accept nothing less than migraine freedom, and the long-term safety and efficacy shown in this interim analysis marks another step toward that goal."1


1. AbbVie Announces Late-Breaking Data at AAN Supporting Long-Term Safety and Efficacy of Atogepant (QULIPTA®) for Preventive Treatment of Migraine. AbbVie. News release. April 12, 2024. Accessed April 12, 2024.

2. Lipton RB, Pozo-Rosich P, Blumenfeld A, et al. Effect of atogepant for preventive migraine treatment on patient-reported outcomes in the randomized, double-blind, phase 3 ADVANCE trial. Neurology. Published online November 17, 2022. doi:10.1212/WNL.0000000000201568

3. U.S. FDA Approves QULIPTA® (atogepant) for Adults With Chronic Migraine. AbbVie. Press release. April 17, 2023. Accessed April 12, 2024.

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