Overviewing Pivotal Phase 3 TEMPLE Trial of Atogepant vs Topiramate: Jessica Ailani, MD

WATCH TIME: 5 minutes

Atogepant (Qulipta; AbbVie), an oral calcitonin gene-related peptide (CGRP) receptor antagonist, was approved in 2021 as a preventive treatment for episodic migraine, and later expanded to include chronic migraine prevention 2 years later. Topiramate (Topamax), an antiepileptic drug, was first approved nearly 30 years ago for epilepsy and in 2004 for migraine prophylaxis in adults. Clinicians typically use topiramate as a first- or second-line treatment; however, the drug has been associated with cognitive side effects, paresthesia, weight loss, and kidney stones.

Recently, investigators announced data from the phase 3 TEMPLE trial, a head-to-head study pinning atogepant against topiramate in a cohort of patients with episodic or chronic migraine. In the study, patients (n = 545) aged 18 and older with at least 4 monthly migraine days underwent a 6-week titration followed by an 18-month maintenance phase, receiving either 60 mg of atogepant once daily or their highest tolerated topiramate dose (50–100 mg/day). All told, atogepant met its primary end point of tolerability, with fewer patients discontinuing treatment because of adverse events (AEs).

To review the findings, NeurologyLive^® turned to migraine expert Jessica Ailani, MD, director of the MedStar Georgetown Headache Center. In the interview, Ailani spoke on the data from both an efficacy and safety perspective, while also providing background on the 2 treatments and their place in the migraine treatment landscape. Most notably, Ailani highlighted the patient-reported outcomes of the trial, including those related to cognitive functioning, which favored atogepant, further adding to its profile as a better-tolerated alternative for migraine prevention.

REFERENCE
1. AbbVie Announces New Data Demonstrating Atogepant (QULIPTA® / AQUIPTA®) Achieves Superiority Across All Endpoints in Phase 3 Head-to-Head Study Compared to Topiramate for Migraine Prevention. News release. AbbVie. June 18, 2025. Accessed July 1, 2025. https://news.abbvie.com/2025-06-18-AbbVie-Announces-New-Data-Demonstrating-Atogepant-QULIPTA-R-AQUIPTA-R-Achieves-Superiority-Across-All-Endpoints-in-Phase-3-Head-to-Head-Study-Compared-to-Topiramate-for-Migraine-Prevention