https://doi.org/10.55788/feb9ec12
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.”
- 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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Table of Contents: EHC 2024
Featured articles
More education on migraine features is needed
CGRP antagonists show different potencies for CGRP isoforms in different vascular compartments
Understanding Migraine Mechanisms
The locus coeruleus is involved in processing pain in migraine
Cortical spreading depolarisation impacts glymphatic flow, with consequences for migraine aura
Central arterial stiffness is involved in the pathophysiology of reversible cerebral vasoconstriction syndrome
Diagnostic and Predictive Tools
AI can enhance migraine diagnosis using easy-to-measure clinical data
New tool adequately captures multiple pain types in trigeminal neuralgia
MRI analyses suggest that migraine is not associated with altered brain white matter
More education on migraine features is needed
Treatment Innovations
PACAP-targeting therapies: a future option for migraine?
Rapid complete responses with atogepant
Cabergoline is a potential add-on treatment option in patients with migraine
Nitroglycerin-induced migraine targetable by different agents
Rimegepant reduces migraine symptoms through 1 year of treatment
Fremanezumab is a treatment option for paediatric patients with episodic migraine
What brain changes are associated with fremanezumab treatment success?
Preventative Therapies in Real-world Context
Low discontinuation rates with preventative galcanezumab in a real-world setting
Side effects are the main culprit for treatment discontinuation in indomethacin-sensitive headache disorders
Biofeedback training can reduce affected days in episodic migraine
Virtual reality interventions can reduce pain perception of chronic headache
Risk Factors and Long-term Management
Can predisposing factors be targeted to reduce new migraine incidence?
Active migraine comes at a high cost in Spain
Many patients, including non-responders, prefer triptans over non-headache-specific medication
Systemic Conditions and Migraine
DPP-4 is better target to lower migraine rates in patients with type 2 diabetes
CGRP antagonists show different potencies for CGRP isoforms in different vascular compartments
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