New Migraine Prevention Drug for Children & Teens Approved in Spain
Spain is poised to offer a preventative medication for migraine in children and adolescents, a treatment option previously unavailable. Research conducted in part by the Vall d’Hebron Institut de Recerca (VHIR) has demonstrated, for the first time, the efficacy and safety of fremanezumab in reducing the frequency of migraines in children aged 6 to 17.
The findings of the phase 3 trial, known as ‘Space’, were recently published in The New England Journal of Medicine. Migraine is a common, debilitating, and often invisible neurological condition affecting not only adults but also approximately 11% of children and adolescents.
Fremanezumab is administered as a subcutaneous injection once a month. According to researchers, this new treatment offers a significant advantage over existing options. Currently, doctors often prescribe medications approved for adults to children, but these treatments frequently demonstrate limited effectiveness and tolerability.
The VHIR has become a leading center for migraine research since the inauguration of the Migraine Adaptive Brain Center in 2019, spearheaded by neurologist Patricia Pozo-Rosich. “Migraine often begins in childhood or adolescence, and until now, there were no preventative treatments specifically approved for this age group,” explains Dr. Pozo-Rosich, Head of the Neurology Service at Vall d’Hebron Hospital and Director of the Headache and Neurological Pain Research Laboratory at VHIR.
Impact on Quality of Life
The lack of effective treatment options for migraine in children and adolescents significantly impacts their quality of life and important life decisions. Migraine episodes in younger patients can involve intense pain, nausea, vomiting, sensitivity to light or sound, and substantial disruption to daily activities.
Fremanezumab is a monoclonal antibody designed to target calcitonin gene-related peptide (CGRP), a molecule crucial in the development of migraine attacks. In adults, this type of medication has already proven effective in migraine prevention with a favorable safety profile.
Dr. Pozo-Rosich anticipates that the medication, which will be administered in hospitals rather than primary care settings, will be available for clinical use throughout the year. However, she notes that pricing still needs to be determined.
The ‘Space’ trial included over 230 patients between the ages of 6 and 17 from multiple countries. Participants were randomly assigned to receive either fremanezumab or a placebo. Results showed that children treated with fremanezumab experienced a significantly greater reduction in the number of migraine days per month compared to the placebo group, with an average reduction of approximately 2.5 days per month.
Preventing Migraine
Dr. Pozo-Rosich emphasizes that lifestyle factors are foundational to migraine treatment. “The lifestyle we lead is the basis of treatment. We know that children and adolescents more affected by migraine often had an unhealthy lifestyle: they didn’t eat breakfast, some started smoking, and they did little physical exercise. First, these habits must be corrected,” she explains. She clarifies that treatments like fremanezumab are typically offered to individuals experiencing four or more migraine days per month.
The study demonstrated that fremanezumab was not only effective but also well-tolerated and safe. “It’s a subcutaneous treatment with a self-injecting pen administered monthly. The advantage is that you can be sure the adolescent receives the injection [because it’s administered in the hospital], and you don’t have to remember to administer it daily,” Dr. Pozo-Rosich highlights. She expresses optimism about this new treatment option.
A Paradigm Shift
The findings from the ‘Space’ study pave the way for a potential shift in how migraine is managed in children and adolescents. Having treatments that target specific mechanisms of the disease could allow for a more personalized and effective approach. Long-term, this could reduce the burden of the disease, prevent the chronic development of migraine into adulthood, and improve the emotional and social well-being of younger patients.
“Treating migraine adequately from the earliest stages can have a very positive impact on the future course of the disease,” Dr. Pozo-Rosich asserts. “It’s important that these patients do not normalize the pain and can develop their lives as normally as possible,” she concludes.