In a subgroup of patients with migraine who completed the full 24-week double-blind treatment period, referred to as treatment completers, treatment with atogepant is associated with greater improvements in clinical efficacy and functional endpoints than topiramate, according to a post hoc analysis of the TEMPLE trial presented at EAN 2026.
The TEMPLE trial was a phase IIIb, double-blind, double-dummy, active-controlled study comparing atogepant 60 mg once daily with the highest tolerated dose of topiramate (50, 75, or 100 mg/day) in adults aged 18–80 years with a documented history of migraine (with or without aura) for ≥12 months.
This post hoc analysis focused on treatment completers, defined as participants who completed the 24-week double-blind period without prematurely discontinuing the study drug and who had ≥165 days of treatment. They received either atogepant (n=209) or topiramate (n=163). [EAN 2026, EPO-0285]
During months 4–6, 73.7 percent of patients treated with atogepant achieved a ≥50-percent reduction in mean monthly migraine days (MMDs) compared with 48.5 percent of those treated with topiramate (relative risk [RR], 1.52; pnominal<0.0001).
Moreover, the mean MMD decreased by 6.63 days from baseline in the atogepant group compared with a 5.01-day reduction in the topiramate group (difference of –1.62 days; pnominal<0.0001).
Regarding functional outcomes, atogepant recipients showed greater improvement in the Headache Impact Test-6 total score from baseline to week 24 than those receiving topiramate (–13.2 vs –9.2; difference of –4; pnominal<0.0001). The Migraine-Specific Quality of Life v2.1 Role Function-Restrictive domain score also improved more in the atogepant group (36.6 vs 26.2; difference of 10.4; pnominal<0.0001).
In addition, a greater proportion of patients treated with atogepant reported being “much better” or “very much better” on the Patient Global Impression of Change scale at week 24 (82.3 percent vs 53.4 percent; RR, 1.54; pnominal<0.0001) than those treated with topiramate.
Patients on atogepant also achieved a greater improvement in cognitive function, as measured by the PROMIS-CF* Abilities Short Form 6a score, from baseline to week 6 (5.4 vs 1.8; difference of 3.6; pnominal=0.0003) than those on topiramate.
Of note, “the double-blind treatment completers randomized to atogepant demonstrated improvements in clinical efficacy and functional endpoints comparable to those observed in the overall modified ITT (mITT) population randomized to atogepant,” said Dr Jan Versijpt from the Department of Neurology at Universitair Ziekenhuis Brussels, Brussels, Belgium.
“Overall, compared with topiramate, atogepant was associated with greater reductions in headache-related functional impairment, improved social and work-related activities, a more favourable impression of overall change, and better cognitive functioning across the mITT and double-blind treatment-completer populations,” he concluded.