Mar 03, 2026
3 min read
An international trial involving the hospital of Vall d'Hebron showed that fremanezumab is effective and safe in preventing the disease in children aged 6 to 17 years.
This year, Spain will have fremanezumab, the first anti-migraine drug in children: a monthly injection.
An international trial involving the Val de Hebron Hospital showed that fremanezumab is effective and safe in preventing the disease in children between 6 and 17 years old.
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During this year, Spain will have a hitherto unavailable preventive medicine for the treatment of migraines in children and adolescents.The Vall d'Hebron Research Institute (VHIR) participated in an international phase 3 study that showed for the first time the effectiveness of fremanezumab, a drug that is also "safe" in reducing the frequency of migraines in children aged 6 to 17 years.
The results of this trial, called 'Space', have been published in 'The New England Journal of Medicine' (NEJM), one of the largest in the world.Migraine is a common, debilitating and underdiagnosed disease that affects not only the adult population, but 11% of children and adolescents.Fremanezumab is available as a subcutaneous injection once a month.
"Migraine is a disease that starts in childhood or adolescence. And at this time there is still no approved preventive treatment"
With the inauguration in 2019 of the Migraine Adaptive Brain Center and led by the prestigious neurologist Patricia Pozo-Rosich—who directs this specialized center—Vall d'Hebron has become a point of reference in migraine research."Migraine is a disease that begins in childhood or adolescence. And for this age there was still no approved preventive treatment," explains Dr. Pozo-Rosich for EL PERIÓDICO. This woman is also head of the Neurology Service at the Vall d'Hebron Hospital and director of the Headache and Neurological Pain Research Laboratory at the VHIR.
The result of "good life"
The lack of treatments to control the disease, especially in these ages, "can impact the quality of life and important decisions made during adolescence."Migraine attacks in minors can cause severe pain, nausea, vomiting, sensitivity to light or noise, and significant disruption to daily life."So far, what we've done is used treatments that are approved for adults, but they have low efficacy and low tolerability," he said.Poso Rosic.
11% of children and young people suffer from migraines
Fremanezumab is a monoclonal antibody designed to act on a peptide linked to the calcitonin gene, a key molecule in the development of migraine attacks.In adults, this type of drug has already been shown to be effective in preventing migraines with a good safety profile.
Pozo-Rosich says the drug, which will be given in hospitals, not clinics, will be available in clinical practice later this year.
However, it has yet to go through the appropriate regulatory processes for specific approval in the pediatric age group, and so far there is very little reliable data on its use in this population.According to Pozo-Rosich's calculations, this drug, which is used in hospitals rather than health centers, will be available in clinical practice later this year.
The Phase 3 "Space" study included more than 230 patients between the ages of 6 and 17 from several countries with migraines.Some received the medicine;Others received a placebo.The results showed that children treated with fremanezumab experienced a "significantly greater" reduction in the number of migraine days compared to the placebo group.Specifically, the treated group reduced migraines by an average of 2.5 days per month.
Migraine prevention
As Pozo-Rosic explains, there are other preventive treatments for migraines, and the first is "education and awareness of the disease".For those who suffer from migraine "four days or more per month".
"The way of life we live is the basis of migraine treatment. Children or young people who suffer from migraines do not eat breakfast, some start smoking, use less..."
Fremanezumab has been shown to be not only 'effective' but also 'well tolerated' and 'safe.' The advantage is that you have to make sure the teenager gets the shot [because it is administered in the hospital], and you don't have to remember to give it every day." He is very optimistic about this new treatment.
A paradigm shift
Findings from the "Space" study open the door to a paradigm shift in migraine treatment in children and adolescents.Targeting treatments at specific mechanisms of disease could provide a more personalized and effective approach.Furthermore, in the long term, this could reduce disease burden, prevent migraine chronicity in adulthood, and improve the emotional and social well-being of young patients.
"Correct treatment of migraine from the early stages can have a very positive effect on the further development of the disease," defends Pozo-Rosic."It is important that these patients do not normalize the pain and can live their lives as normally as possible," he concludes.
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