Three phase 3 clinical trials evaluating atogepant for migraine prevention demonstrated measurable effects within the first four weeks of treatment.

The research, published in Neurology, analyzed data from the ADVANCE, ELEVATE, and PROGRESS trials involving participants aged 18–80 with episodic or chronic migraine. Study populations were predominantly female (87.2%–89.5%) and White (59.7%–95.8%).

Atogepant reduced the likelihood of migraines on day 1 compared to placebo, with significant odds ratios: 0.39 in ADVANCE, 0.53 in ELEVATE, and 0.63 in PROGRESS. Weekly migraine frequency decreased starting in week 1. The least squares mean differences (LSMDs) from placebo were -0.74 in ADVANCE, -1.07 in ELEVATE, and -0.85 in PROGRESS. Baseline monthly migraine days were higher in PROGRESS (18.95–19.17) compared to ADVANCE (7.50–7.74) and ELEVATE (9.08–9.27).

Functional outcomes improved by week 1. Activity Impairment in Migraine-Diary (AIM-D) scores showed significant reductions in the performance of daily activities (PDA) domain, with LSMDs of -4.22 in ADVANCE, -6.76 in ELEVATE, and -5.83 in PROGRESS. The European Quality-of-Life 5-Dimension 5-Level (EQ-5D-5L) scores reflected quality-of-life improvements by weeks 1 to 2.

Treatment-emergent adverse events during the first 4 weeks occurred in 36.4%, 33.3%, and 41.0% of atogepant-treated patients across the three trials, versus 33.3%, 29.9%, and 29.4% in placebo groups. Treatment-related adverse events were more frequent with atogepant (e.g., 16.9% in ADVANCE vs. 6.3% in placebo).

Patients using frequent opioids or barbiturates and those failing more than 4 preventive treatments were excluded. AbbVie funded the study, and multiple authors disclosed relationships with pharmaceutical companies.