Val d'Hebron participated in the proof-of-concept study

Migraine is a common, disabling and often undiagnosed disease that affects 11% of the population, not just the elderly.

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Dr. Pozo-Rozic at Dr. Carona

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Caronna's doctor was busy ing for a consultation

Dr. Caronna is doing a test on the patient

Fremanezumab treatment becomes the first approved treatment to show efficacy in children and adolescents, a key stage because it is among the most disabling and targets the peak of the disease.

Migraine is a common and often invisible neurological disorder that affects not only adults but also 11% of children and adolescents. However, the options for traditional childhood immunizations are limited, with little scientific evidence, and in many cases the drugs used are not specifically designed or approved for this age group.

The international phase 3 study, carried out with the participation of the Vall d'Hebron University Hospital, showed that the drug fremanezumab is effective and safe in reducing the frequency of migraines in children and adolescents.The results of the study, known as SPACE, were recently published in The New England Journal of Medicine, one of the world's most prestigious medical journals.

Migraine attacks in children and adolescents can cause severe pain, nausea, vomiting, sensitivity to light or noise, and significant disruption of daily life.This condition can interfere with school attendance, academic performance, social relationships, and the emotional well-being of both patients and their families.

“Migraine in pediatric age has a very big impact on quality of life, but for many years we have had few therapeutic tools and strong scientific evidence,” explains Dr.Patricia Pozo-Rosich, Head of the Neurological Service and Headache Department at the Vall d'Hebron University Hospital, Head of the Headache and Neurological Pain Group at the Vall d'Hebron Research Center (Val d'Hebron) and Director of the Vall d'Hebronine Research Institute (VHIR) and Director of the Vall d'Hebronine Research Institute (VHIR).Vallive Migraine Research Center (VHIR) d'Ebron.

Fremanezumab is an anti-monoclonal antibody designed to block calcitonin gene-related peptide (CGRP), a molecule important in the development of migraine.For adults, this type of medication has already been shown to be effective in preventing migraines with a good safety record, although it still needs to go through the regulatory process to be approved directly in children, and until now there was no strong data on its work in this population.

The SPACE study filled this gap in knowledge and evaluated whether fremanezumab could also be an effective and safe option for children and adolescents with episodic migraine, characterized by headaches less than 15 days per month with episodes that vary in intensity and duration.

The phase 3 trial included more than 230 patients between 6 and 17 years of age from several countries who received this diagnosis during the study. Patients received subcutaneous injections of freemanezumab or placebo. Symptoms are closely monitored. Frequency of migraines and may cause side effects. The main objective was to evaluate the reduction in the number of migraine days per month, as well as other variables related to the clinical response and safety of treatment.

The results show that children and adolescents treated with fremanuzumab had a reduction in the number of migraine days compared to the placebo group.Specifically, the treatment group had an average of 2.5 fewer migraine days per month compared to about 1.4 days in the placebo group.

Additionally, about 47% of patients in the treatment group achieved at least a 50% reduction in migraine days, compared with about 27% of patients in the placebo group, the standard used to consider preventive treatment clinically relevant.

In terms of safety, the drug shows a favorable profile, with negative effects seen in the placebo group, mainly local reactions at the injection site.

"The results of the study are very encouraging, as they show that we can offer a specific, effective and well-tolerated preventive treatment to a population that until now has had few options," emphasizes Dr.Pozo-Rosich."Participating in international clinical trials at this level allows us to directly contribute to scientific evidence and at the same time bring therapeutic innovation closer to our patients," he points out.

The results of the SPACE study open the door to a paradigm shift in the treatment of migraine in children and adolescents.Treatments that target specific mechanisms of the disease may provide a more personalized and effective approach, thereby avoiding the use of drugs used in this population to date that have not been specifically developed or studied in children and adolescents.

In the long term, this may reduce disease burden, prevent migraine chronicity in adults, and improve emotional and social well-being in young patients.

Proper treatment of migraines in the early stages can have a very positive effect on the future course of the disease, explains Dr. Pozo-Rozic."These patients must be able to not normalize the pain and lead as normal a life as possible," he said.

The SPACE clinical trial, published in The New England Journal of Medicine, examines the first use of fremanezumab in the prevention of migraine in girls, boys and adolescents.

Neurologie, General Hospital

Psychiatry, Ziral Hospital

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