Migraine Prevention: New Treatment Approved for Children & Teens
A new treatment option is on the horizon for children and adolescents struggling with migraine, a condition often underestimated and undertreated in younger populations. International phase 3 trial results, involving participation from the Vall d’Hebron Hospital in Barcelona, have demonstrated the efficacy of a preventative treatment specifically for pediatric migraine sufferers. This marks a significant step forward in managing a neurological condition affecting approximately 11% of children and teenagers.
Historically, preventative treatment options for pediatric migraine have been limited. The study, published in The New England Journal of Medicine, focused on fremanezumab, marketed under the brand name Ajovy. While previously approved by the European Commission in for adult use, this research provides compelling evidence for its effectiveness and safety in younger patients. The U.S. Food and Drug Administration (FDA) has also granted approval for this expanded indication.
The phase 3 SPACE clinical trial (NCT03539393) involved 237 individuals aged 6 to 17 with episodic migraine – defined as fewer than 14 headache days per month. Participants were randomized to receive either Ajovy or a placebo for 12 weeks. Key findings revealed that those treated with Ajovy experienced a significant reduction of 2.5 migraine days per month compared to 1.4 days in the placebo group (). Monthly headache days were reduced by 2.6 days with Ajovy versus 1.5 days with placebo. Nearly half (47.2%) of patients receiving Ajovy achieved at least a 50% reduction in migraine days, compared to 27% in the placebo group.
Ajovy is a calcitonin gene-related peptide (CGRP) antagonist, a class of medication designed to block the activity of CGRP, a molecule involved in migraine development. The medication is administered as a 225-mg/1.5-mL single-dose injection, available in a prefilled autoinjector or syringe, and can be given by a healthcare professional or self-administered, or administered by a parent or caregiver at home. The dosage for adolescents (12-17 years) is the same as that used in adults, while children aged 6-11 receive half the dose.
“Pediatric migraine is a complex condition that can significantly impact a child’s daily life, from school performance to emotional well-being,” says Jennifer McVige, M.D., from the DENT Neurologic Institute in Buffalo, New York. “Having an FDA-approved treatment like Ajovy offers an important option, providing a targeted approach to preventive treatment for episodic migraine that can help reduce the frequency of attacks in younger patients and help clinicians manage this often-overlooked condition.”
The safety profile observed in the pediatric trial was consistent with that seen in adult studies, with similar rates of treatment-emergent adverse events in both the Ajovy and placebo groups. Serious adverse events and treatment discontinuations were infrequent, and no new safety concerns were identified.
According to Patricia Pozo-Rosich, head of the Neurology and Headache Unit at Vall d’Hebron Hospital, this approval represents a “paradigm shift” in migraine management for young people. She notes that migraine typically begins around ages 13-14, and previously, limited treatment options were available. “Patients would often reach adulthood with four or five years of uncontrolled illness,” she explains. “As with all brain diseases, we need to treat and prevent as early as possible.”
The potential for long-term benefits is also a key consideration. Dr. Pozo-Rosich speculates that early intervention in children may reduce the need for lifelong treatment. “I want to think that in children, if you control the disease early, you probably don’t need lifelong treatments,” she stated. “It’s very different to find someone who has been suffering from uncontrolled migraine for ten years than someone who is just starting.”
Fremanezumab is an antibody monoclonal designed to target the calcitonin gene-related peptide. We see considered a hospital medication for outpatient dispensing and is administered monthly via injection. The cost of the medication is approximately 500 euros per month for adults.
Migraine is recognized as the most disabling disease in adolescence, and until now, there has been a lack of modulating treatments available. This new therapeutic tool offers hope for preventing years of uncontrolled illness in young people. The approval of Ajovy for pediatric episodic migraine represents a significant advancement in addressing the needs of this often-overlooked patient population.