Home > Neurology > EHC 2024 > Treatment Innovations > Fremanezumab is a treatment option for paediatric patients with episodic migraine

Fremanezumab is a treatment option for paediatric patients with episodic migraine

Presented by
Prof. Patricia Pozo-Rosich, Vall d’Hebron Institute of Research, Spain
Conference
EHC 2024
Trial
Phase 3, SPACE-EM
Doi
https://doi.org/10.55788/feb9ec12
Fremanezumab versus placebo significantly reduced the number of migraine days with comparable safety in children and adolescents with episodic migraine, according to phase 3 trial data.

SPACE-EM (NCT04458857) was a randomised, double-blind, multicentre, parallel-group, phase 3 trial assessing fremanezumab versus placebo for the prevention of episodic migraine in children and adolescents (6–17 years of age) [1]. Participants were included if they had a migraine diagnosis according to ICHD-3 with a duration of at least 6 months prior to screening, and ≤14 headache days per month in the 3 months before screening. Fremanezumab dosing was weight-based (120 mg every 4 weeks if <45kg or 225 mg every 4 weeks if ≥45kg,) and the total treatment duration was 12 weeks. The primary endpoint of the trial was least squares (LS) mean change from baseline in average monthly migraine days during the 12-week treatment period. In total, 112 participants received placebo, while 36 received fremanezumab 120 mg and 87 received fremanezumab 225 mg.

Overall, fremanezumab compared with placebo significantly reduced the average number of monthly migraine days during the treatment period (LS mean -2.5 vs -1.4; P=0.0210). Furthermore, the number of participants with at least a 50% reduction in mean monthly migraine days over the 12-week treatment period was significantly higher with fremanezumab than placebo (47.2% vs 27.0%; P=0.016). In terms of safety, injection-site erythema was more common with fremanezumab compared with placebo (10% vs 5%), but serious adverse events (2% vs 3%) and severe adverse events (3% vs 4%) occurred at similar rates.

“We can conclude that in this study in episodic migraine in children and adolescents, fremanezumab was significantly superior over placebo,” said Prof. Patricia Pozo-Rosich (Vall d’Hebron Institute of Research, Spain), adding that “the safety and tolerability profile was consistent with results we have in adults. I think these results are good news for our children and adolescents as, hopefully, in the future, we will be able to offer them an effective preventative treatment for episodic migraine.”

  1. Hershey AD, et al. Efficacy and safety of fremanezumab for the preventive treatment of episodic migraine in children and adolescents: a phase 3, randomised, double-blind, placebo-controlled study. 18th European Headache Congress, 4–7 December 2024, Rotterdam, the Netherlands.

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