Migraine is a common, disabling, and often invisible neurological disease that affects not only adults but also 11% of children and adolescents. However, preventive treatment options in pediatric patients have traditionally been very limited, with scarce scientific evidence and medications that, in many cases, are not specifically designed or approved for this age group.

An international phase 3 study, with the participation of Vall d'Hebron University Hospital, has demonstrated that the drug fremanezumab is effective and safe in reducing migraine frequency in children and adolescents. The results of the study, known as SPACE, have recently been published in the The New England Journal of Medicine, one of the most prestigious medical journals worldwide.

Migraine episodes in children and adolescents may involve intense pain, nausea, vomiting, hypersensitivity to light or sound, and significant impairment of daily life. This situation can interfere with school attendance, academic performance, social relationships, and emotional well-being, both for patients and their families.

“Pediatric migraine has a major impact on quality of life, yet for many years we have had very few therapeutic tools supported by solid scientific evidence,” explains Dr. Patricia Pozo-Rosich, Head of the Neurology Department and the Headache Unit at Vall d'Hebron University Hospital, head of the Headache and Neurological Pain Group at the Vall d’Hebron Research Institute (VHIR), and director of the Migraine Adaptive Brain Center at Vall d’Hebron.

Fremanezumab: a treatment targeting the biological basis of migraine

Fremanezumab is a monoclonal antibody specifically designed to act on the calcitonin gene-related peptide (CGRP), a key molecule involved in the development of migraine attacks. In adults, this type of drug has already proven effective for migraine prevention with a favorable safety profile. However, it still needs to undergo the appropriate regulatory processes for specific approval in pediatric patients, and until now there has been very limited robust data regarding its use in this population.

The SPACE study fills this knowledge gap and evaluates whether fremanezumab can also be an effective and safe option for children and adolescents with episodic migraine, characterized by fewer than 15 headache days per month, with episodes that may vary in intensity and duration.

The phase 3 trial included more than 230 patients aged 6 to 17 from several countries with this diagnosis. During the study, patients received subcutaneous injections of fremanezumab or placebo, with rigorous monitoring of symptoms, migraine episode frequency, and the possible occurrence of adverse events. The primary objective was to assess the reduction in the number of monthly migraine days, as well as other variables related to clinical response and treatment safety.

Fewer migraine days and good tolerability

The results show that children and adolescents treated with fremanezumab experienced a significantly greater reduction in the number of migraine days compared to the placebo group. Specifically, the treated group reduced migraine days by an average of nearly 2.5 days per month, whereas the placebo group showed a reduction of approximately 1.4 days.

In addition, around 47% of patients in the treated group achieved at least a 50% reduction in monthly migraine days, compared to approximately 27% of patients in the placebo group — a criterion commonly used to determine whether a preventive treatment is clinically meaningful.

Regarding safety, the drug demonstrated a favorable profile, with mild adverse events similar to those observed in the placebo group, mainly local reactions at the injection site.

“The study results are very encouraging, as they show that we can offer a specific, effective, and well-tolerated preventive treatment to a population that until now had very few alternatives,” highlights Dr. Pozo-Rosich. “Participating in international clinical trials of this level allows us to contribute directly to scientific evidence while bringing therapeutic innovation closer to our patients,” she adds.

A possible paradigm shift in pediatric migraine treatment

The results of the SPACE study open the door to a potential paradigm shift in the management of migraine in children and adolescents. Having treatments that target specific mechanisms of the disease may enable a more personalized and effective approach, moving away from the use of medications that have traditionally been prescribed in this population without being specifically developed or studied for children and adolescents.

In the long term, this could reduce the burden of disease, prevent migraine chronification in adulthood, and improve the emotional and social well-being of younger patients.

“Treating migraine appropriately from the earliest stages can have a very positive impact on the future course of the disease,” explains Dr. Pozo-Rosich. “It is important that these patients do not normalize pain and are able to develop their lives as normally as possible.”