STAMFORD — The New England Institute for Clinical Research is partnering with New-Haven based Biohaven Pharmaceuticals to recruit participants in a clinical trial to study whether a drug used to treat migraines in adults could be used in children.
The drug, called Rimegepant, is produced by Biohaven Pharmaceuticals and was approved by the FDA for use in adults in May 2021. It works by blocking the receptor sites for calcitonin gene related peptides; researchers have found that the release of these amino acids in the brain have been connected to the onset of migraines.
An April 2022 review article in Biodrugs said that clinical trials have shown that Rimegepant has been effective for adults in reducing pain two hours into a migraine headache and in reducing other symptoms such as nausea and sensitivity to light and sound. It has also been found to reduce the frequency that people have migraine headaches.
Dr. Kate Mullin, a neurologist and associate medical director at the New England Institute for Clinical Research, said that doctors have been prescribing rimegepant for adults for a while now, and that it is the only drug shown to reduce both pain during the moment of the headache and to have success preventing migraine headaches. She said side effects are mild, with about 2 percent of patients experiencing nausea, and added that earlier stages of the trial have not shown children to have any unusual side effects.
The study will be conducted in two phases. The first part, which lasts 20 weeks, is a double-blind placebo-controlled study in which participants can receive either a placebo or the drug. After 20 weeks, the trial will switch to being an “open label,” meaning that all participants will be able to take the drug. The open label phase will last a year.
A review article in the Journal of Headache and Pain estimated from a review of about 350 publications that the global prevalence of migraine headaches is about 15 percent. Mullin said that between eight and 12 percent of children have migraine headaches, with that number increasing as they reach teenage years.
She also said that migraines in children don’t always present in the same way that they do in adults.
“It’s important to realize that it can be a lot more subtle in kids. In fact, sometimes children don’t even feel pain. They get acutely nauseous. They can get sort of pale. They can get stomach pain without head pain. They can get dizzy, really fatigued. So it looks very different,” she said.
Mullin added that when children do present with pain, it can last for a lot less time than in adults. In adults, the minimum length of a migraine is three hours; in children, it can be as little as 15 to 20 minutes.
Mullin said that while migraines are debilitating for adults, they can place even more pressure on children, who may have to catch up from days of missed school as a result.
“These kids are on a timeline for school and academic achievements and if they fall off because they’re with a migraine for a week, two weeks —- that can really set you back. And then there’s a lot of anxiety and pressure of having to catch back up on the work that you missed,” she said.
She said that children with migraines are also statistically more likely to suffer from depression and anxiety. Low socioeconomic status and a history of abuse are also factors that make it more likely for children to have migraines.
Additionally, she said, doctors have become more “aggressive” in trying to treat children who have frequent, intense migraines, with the knowledge that, as adults, their migraines could be more resistant to treatment.
Mullin said that while doctors do sometimes provide Rimegepant off-label for children, she felt it would be reassuring for parents if the drug was tested for children.
Parents who want to enroll their children in the trial can call the New England Institute for Clinical Research at (203) 914-1903. To participate, children have to have at least one migraine per month and a six-month history of migraines.
Comments by Mullin were corrected to remove a reference to FDA approval. Mullin said the study would reassure parents by testing the drug for use with children