Treatment discontinuation was 12% with QULIPTA versus 30% with topiramate in the TEMPLE trial
Key Facts
AbbVie announced on October 29, 2026, the publication of TEMPLE trial results in The Lancet Neurology, reporting that 12% of participants who received atogepant discontinued treatment because of adverse events, compared with 30% of those who received topiramate. The trial directly compared the two drugs for migraine prevention in adults and assessed tolerability, safety and efficacy. Atogepant, marketed as QULIPTA, was given at a dose of 60 mg once daily. The comparison group received the highest tolerable dose of topiramate: 50, 75 or 100 mg daily. The results place tolerability and the ability to continue treatment alongside reductions in migraine days among the key measures in the published comparison.
TEMPLE was a randomized, double-blind phase 3b trial designed to compare the two treatments directly. The double-blind treatment period lasted 24 weeks, followed by a 52-week open-label treatment period. According to the study summary published on PubMed, the open-label period was still ongoing when the results were published. The trial included 545 adults with episodic or chronic migraine, who were randomly assigned. It was conducted at 73 sites in 12 countries, and participants were required to have a history of migraine and at least four headache days per month.
Of the 545 participants randomly assigned, 540 entered the safety population used for the adverse-event comparison. That group included 273 participants who received atogepant and 267 who received topiramate. Treatment discontinuation because of adverse events was recorded in 12% of the atogepant group, compared with 30% of the topiramate group during the 24-week blinded period. AbbVie estimated the relative risk at 0.4, with a 95% confidence interval of 0.3 to 0.6 and a p-value of less than 0.0001. This finding is consistent with the company's description of the study as showing better tolerability for atogepant than the active comparator.
In the efficacy measure over months 4 to 6 of the double-blind treatment period, mean monthly migraine days fell from baseline by 6.3 days among participants who received atogepant. The corresponding reduction was 4.5 days in the topiramate group. AbbVie reported a p-value of less than 0.0001 for the difference. This measure adds a quantitative comparison of the treatments to the treatment-discontinuation data, tracking changes in the number of headache days during the specified months of the study. The company also reported statistically significant improvements with atogepant in headache-related disability, migraine-specific quality of life, patient-reported global improvement and cognitive function.
TEMPLE results were not the company's first announcement about the trial's performance. On June 18, 2025, AbbVie said atogepant had met the primary endpoint, which concerned a reduction in discontinuation due to adverse events compared with topiramate, and that all six secondary endpoints were statistically significant. The company said at the time that atogepant was approved in 60 countries. The blinded-period results published now add detailed comparative figures on discontinuation and headache days, while the 52-week open-label follow-up period was still ongoing when the study was published. In trading, EL7 data showed AbbVie shares closed at $294.89 on October 30, 2026. The stock had closed at $286.74 on October 26, $286.44 on October 27, $285.99 on October 28 and $290.97 on October 29.