Atogepant Meets Primary Endpoint in Phase 3 Menstrual Migraine Trial

Treatment with Qulipta (atogepant; AbbVie, North Chicago, IL), an oral calcitonin gene-related peptide (CGRP) receptor antagonist, was associated with reductions in migraine days during the perimenstrual period in adults with menstrual migraine, according to topline results from the phase 3 LUNA clinical trial (NCT06806293) reported by AbbVie.

LUNA is a multicenter, randomized, double-blind, placebo-controlled phase 3 study with an open-label extension evaluating Qulipta for short-term prevention of menstrual migraine. The trial included 468 adults whose migraine attacks followed a menstrual pattern, with diagnoses classified as pure menstrual migraine or menstrually related migraine under International Classification of Headache Disorders (ICHD-3) criteria. Participants with and without aura were eligible, and study sites were located in Europe and Asia.

Participants received atogepant or placebo for 7 consecutive days, beginning 3 days before the onset of menses, across 3 menstrual cycles. The primary endpoint was change from baseline in migraine days during the perimenstrual period, averaged across the 3 menstrual cycles of the double-blind period.

Phase 3 LUNA Findings

• Treatment with Qulipta met the primary endpoint, with a greater reduction in migraine days during the perimenstrual period compared with placebo.
• The average reduction in perimenstrual migraine days was 1.20 days with Qulipta compared with 0.40 days with placebo.
• The placebo-adjusted difference was 0.80 fewer migraine days during the perimenstrual period (P<.0001).
• Treatment with Qulipta also met all 8 ranked secondary endpoints versus placebo (P<.0001).
• Secondary endpoints included measures of 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.
• AbbVie reported that safety findings were consistent with the known safety profile of atogepant and that no new safety signals were observed.

Potential Implications for Clinical Practice

The results may be clinically relevant because menstrual migraine attacks often occur predictably around menses and can be more severe, longer lasting, or less responsive to acute medication than nonmenstrual attacks. According to a statement from AbbVie, no treatments are currently approved specifically for menstrual migraine.

Source

AbbVie. AbbVie extends migraine leadership with positive phase 3 atogepant results in menstrual migraine. Published September 10, 2026. Accessed September 14, 2026. https://news.abbvie.com/2026-09-10-AbbVie-Extends-Migraine-Leadership-with-Positive-Phase-3-Atogepant-Results-in-Menstrual-Migraine