Phase 3 LUNA study: atogepant reduces menstrual migraine days vs. placebo

Atogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, met the primary endpoint and all 8 ranked secondary endpoints in the phase 3 LUNA study evaluating its use for the preventive treatment of menstrual migraine in adults, according to an announcement from AbbVie.¹

Menstrual migraine includes pure menstrual migraine and menstrually-related migraine, with attacks occurring during a period of increased biological vulnerability around menstruation. In the Chronic Migraine Epidemiology and Outcomes–International (CaMEO-I) study, 66% (4,220/6,395) of eligible respondents reported migraine attacks around menstruation.¹

How was the LUNA study designed?

LUNA (NCT06806293) was a phase 3, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension evaluating the efficacy, safety, and tolerability of atogepant for the preventive treatment of menstrual migraine. The study enrolled 468 adult female participants with pure menstrual migraine or menstrually-related migraine, with or without aura, as defined by the International Classification of Headache Disorders, 3rd edition (ICHD-3), at study locations across Europe and Asia.^1,2

The study evaluated atogepant taken for 7 consecutive days starting 3 days before the onset of menses over 3 menstrual cycles. The primary endpoint evaluated change from baseline in migraine days during the perimenstrual period, averaged across 3 menstrual cycles during the double-blind period. Secondary endpoints assessed headache days, moderate or severe headache days, acute medication use days, migraine days with moderate or severe headache, responder outcomes, functional disability, and cognitive function.¹

Atogepant’s reduction in migraine days

Atogepant demonstrated a greater reduction than placebo in migraine days during the perimenstrual period, averaged across 3 menstrual cycles.

The average reduction was 1.20 days with atogepant vs. 0.40 days with placebo, corresponding to 0.80 fewer migraine days compared to placebo (P < 0.0001). Statistically significant improvements were also observed with atogepant vs. placebo across all 8 ranked secondary endpoints (P < 0.0001), including:

• Measures of headache burden
• Acute medication use
• Functional disability
• Cognitive function
• Responder outcomes

Safety was consistent with the known profile of atogepant. No new safety signals were observed.

“Menstrual migraine attacks are generally more severe and more difficult to treat, making timely intervention particularly important,” said Cristina Tassorelli, MD, PhD, professor of neurology and director of the Headache Science Centre at IRCCS Mondino Foundation, University of Pavia, Italy. “LUNA is the first study of a CGRP-targeted treatment to report positive results specifically in menstrual migraine and meets an important unmet need for women.”

Atogepant (Qulipta; AbbVie) is currently approved in 60 countries for preventive treatment of migraine, taken once daily, and for acute treatment, taken as needed.

AbbVie plans to submit the LUNA data to health authorities and present findings at future medical congresses.

References:

1. AbbVie extends migraine leadership with positive phase 3 atogepant results in menstrual migraine. AbbVie. News release. Published September 10, 2026. Accessed September 10, 2026. https://news.abbvie.com/2026-09-10-AbbVie-Extends-Migraine-Leadership-with-Positive-Phase-3-Atogepant-Results-in-Menstrual-Migraine
2. Study of Oral Atogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine (ATO MM). ClinicalTrials.gov. Updated September 4, 2026. Accessed September 10, 2026. https://clinicaltrials.gov/study/NCT06806293