ECLIPSE Trial Data Highlights Atogepant's Effectiveness Over Placebo for Migraine Treatment

AbbVie Presents Key Findings from ECLIPSE Trial

On December 1, 2025, AbbVie (NYSE: ABBV) unveiled groundbreaking data at the 19th European Headache Congress, confirming the superiority of Atogepant over placebo in treating acute migraine. The ECLIPSE trial results revealed a statistically significant advantage in headache freedom within two hours post-administration for patients suffering from initial migraine attacks.

In this pivotal Phase 3 trial, Atogepant demonstrated a headache resolution rate of 24.3% compared to 13.1% for the placebo group. These findings will be further discussed in a late-breaking session at the congress in Lisbon, Portugal, from December 3 to 6.

Primal Kaur, M.D., MBA, Senior Vice President at AbbVie, emphasized the significance of the ECLIPSE trial results in addressing unmet needs in migraine treatment, stating, "This is a major step toward freeing people suffering from migraines and highlights our ongoing efforts to enhance treatment options. Upon successful EMA approval, Atogepant will provide a new therapeutic choice for acute migraine episodes in Europe."

The ECLIPSE trial, which enrolled 1,223 adult participants with a history of migraine, assessed the safety and efficacy of Atogepant (60 mg) compared to placebo. Within two hours after administration, a significant reduction in the most bothersome migraine symptoms was also reported, showcasing the comprehensive benefits of the treatment.

Annelies Van Dycke, M.D., Ph.D., MBA, the head of neurology at AZ Sint-Jan Hospital in Bruges, Belgium, and the principal investigator of the ECLIPSE trial, commented on the impact of migraines on daily life. "Migraine is a debilitating condition that significantly affects quality of life. Many existing treatments fall short, leaving patients without effective options. If we can integrate targeted treatments like Atogepant into comprehensive care plans, we could transform the lives of those affected by migraines."

The safety profile of Atogepant over 24 weeks of administration was consistent with previous studies evaluating its use for migraine prevention. No new safety signals were identified in this acute setting. During the double-blind period, common adverse events included nasopharyngitis (4.6%) and upper respiratory infections (2.3%).

Understanding Migraine

Migraine is a prevalent and debilitating neurological disorder affecting approximately 14% of the global population, with a higher incidence in women compared to men. This condition most commonly manifests in adults aged 25 to 55, leading to severe, pulsating headaches accompanied by sensitivity to light and sound and nausea. Beyond the physical toll, migraine has significant socio-economic implications, consistently presenting a greater economic burden than cardiovascular disease or diabetes. In Europe, the loss in productivity due to migraines represents 1.2% to 2.0% of GDP, heavily impacting unpaid labor, particularly among women.

About the ECLIPSE Trial

The ECLIPSE trial is a 24-week, multi-center, randomized, double-blind, placebo-controlled study that evaluated the efficacy of Atogepant in treating acute migraine. Participants were selected based on a diagnosis of migraine with or without aura, experiencing moderate to severe migraine attacks 2-8 times each month. The primary endpoint was headache freedom at the two-hour mark post-dosing, with significant secondary endpoints including the resolution of the most bothersome migraine symptom.

About Atogepant

Atogepant is a novel oral CGRP receptor antagonist developed for the preventive treatment of migraines in adults. CGRP and its receptors are implicated in the pathophysiology of migraines, with research indicating increased CGRP levels during migraine attacks. Atogepant is currently approved as a preventive treatment in over 60 countries and is marketed under the names AQUIPTA in the EU and QULIPTA in the U.S., Canada, Israel, Puerto Rico, and other regions.

AbbVie's Commitment to Migraine Research

AbbVie is dedicated to supporting migraine patients and advancing treatment options to meet their needs effectively. Through continued innovation and collaboration with healthcare professionals, AbbVie aims to overcome barriers to effective migraine treatment. For more information about AbbVie, please visit www.abbvie.com.