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SAN DIEGO -- Fremanezumab (Ajovy) cut monthly migraine days in children and adolescents with episodic migraine, according to the SPACE trial. The phase III study showed a reduction in monthly migraine days in patients (mean age about 13 years) with fremanezumab treatment versus placebo (-2.5 vs -1.
4 days per month, P=0.0210), said Christina Szperka, MD, of Children's Hospital of Philadelphia. Treatment also reduced headache days and increased the number of patients achieving a 50% or higher reduction in monthly migraine days.
But reductions in disability and improvement in quality of life (QoL) did not reach statistical significance, she reported at the American Academy of Neurology annual meeting. Fremanezumab is a calcitonin-gene related peptide (CGRP) pathway monoclonal antibody that is FDA approved for adults with both episodic and chronic migraine. "It's a very exciting day to be able to stand here and present to you a positive placebo-controlled trial in pediatric migraine," Szperka said.
"This is the first completed phase III trial of CGRP-targeted therapies in children and adolescents and demonstrates both safety and efficacy. On behalf of my colleagues in the world of pediatric headache, I can tell you that we hope this is the first of several trials." The challenge with trials in this population is that there is a "very high rate of placebo response, and so it's very difficult to prove efficacy of medications," Szperka said.
"In clinical practice, that placebo response is actually a positive thing, but in trials, this made it very difficult to prove efficacy." Hope O'Brien, MD, MBA, of the Headache Center of Hope in Cincinnati, agreed that results like these have been a long time coming. "There's been just a paucity of targeted therapies for children and adolescents," she told MedPage Today.
"For the first time, there's a CGRP-targeting treatment that has demonstrated statistical and clinically meaningful results in children as young as the age of...
Susan Jeffrey, Contributing Writer.
