Tolerability, safety, and efficacy of atogepant versus topiramate in adults with migraine (TEMPLE): a randomised, head-to-head, phase 3b trial
Abstract
Background: Oral calcitonin gene-related peptide (CGRP) receptor antagonists such as atogepant have been approved for preventive treatment of migraine but have not been compared directly with conventional oral non-specific preventive treatments. Topiramate is a widely used conventional oral non-migraine-specific preventive treatment for migraine but its use is often limited by poor tolerability. We aimed to evaluate the tolerability, safety, and efficacy of atogepant versus topiramate in adults with migraine, to provide direct comparative evidence to help inform treatment selection.
Methods: TEMPLE was a phase 3b, randomised, double-dummy, active-controlled trial with a 24-week double-blind treatment period and a 52-week open-label treatment period, done in sites with experience in diagnosing and treating migraine across 12 countries (Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Portugal, and the UK). Participants had a history of migraine and at least 4 migraine days per month on average across the 3 months before screening and during the combined screening and baseline period. Participants were randomly assigned 1:1 to atogepant (60 mg once daily) or topiramate (highest tolerated dose of 50 mg/day, 75 mg/day, or 100 mg/day) using interactive response technology. The primary endpoint assessed tolerability by measuring treatment discontinuation owing to treatment-emergent adverse events during the double-blind period in the safety…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 273 participants or records.
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