Key clinical point: Despite no significant improvement in pain-free status, high-dose zolmitriptan nasal spray (ZNS) provided clinically relevant improvements with a favorable safety profile in the acute treatment of migraine in patients aged 6-11 years.
Major finding: At 2 hours postdose, high-dose ZNS vs placebo led to a numerically higher proportion of patients achieving pain-free status (odds ratio [OR] 1.51; 95% CI 0.96-2.38) and a significantly higher proportion of patients reporting a headache response (OR 1.75; P = .009). No serious treatment-emergent adverse events were reported.
Study details: This was a phase 3 crossover trial with an open-label extension including 186 patients aged 6-11 years with migraine with or without aura who were randomly assigned to receive ZNS (patients <50 kg: 2.5 or 1 mg; patients ≥50 kg: 5 or 2.5 mg) or placebo.
Disclosures: This trial was funded by AstraZeneca and conducted by Amneal Pharmaceuticals LLC, which also supported the study’s publication. Two authors declared being employees of Amneal or a company contracted by Amneal. Two authors reported ties with various other sources.
Source: Yonker ME et al. A multicenter, randomized, double-blind, placebo-controlled, crossover trial to evaluate the efficacy and safety of zolmitriptan nasal spray for the acute treatment of migraine in patients aged 6 to 11 years, with an open-label extension. Headache. 2022;62(9):1207-1217 (Oct 26). Doi: 10.1111/head.14391