1. Absence of moderate or severe headache 24 hours following administration of treatment drug was significantly greater among patients with migraine attacks that were treated with ubrogepant during the prodrome phase.
2. Adverse events were slightly more frequent in the ubrogepant group versus placebo.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Ubrogepant, a calcitonin gene-related peptide (cGRP) receptor antagonist, is approved for acute migraine treatment. However, its use during the prodromal phase to reduce the frequency of subsequent migraine headaches is not well understood. This phase 3 randomized controlled trial aimed to evaluate the safety, efficacy, and tolerability of ubrogepant when administered during the prodrome phase of a migraine attack. The primary outcome was the absence of moderate or severe headache within 24 hours after drug use, while the key secondary outcome was the absence of any headache. According to study results, ubrogepant demonstrated effectiveness, with a significantly higher rate of headache absence compared to placebo. This study was strengthened by individuals of all age groups with a chronic history of migraines, thus adding to the validity of the findings.
Click to read the study in The Lancet
Relevant Reading: Ubrogepant for the Treatment of Migraine
In-depth [randomized-controlled trial]: Between Aug 21, 2020, and Apr 19, 2022, 1087 patients were screened for eligibility across 75 research centers in the USA. Included were patients ≥ 18 years with ≥ 1-year history of migraine and 2-8 migraine attacks per month. Altogether, 466 patients (239 in placebo then ubrogepant 100 mg and 227 in ubrogepant 100 mg than placebo) were included in the final analysis. The primary outcome of absence of moderate or severe headache within 24 hours was significantly higher after ubrogepant administration compared to placebo (46% vs. 29%, odds ratio [OR] 2.09, 95% confidence interval [CI] 1.63-2.69, p<0.0001). Furthermore, adverse events were reported in both groups but occurred more frequently with ubrogepant than placebo (17% vs. 12%). Findings from this study suggest that ubrogepant is both safe and effective for the acute treatment of migraine attacks.
Image: PD
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