Clinical research trial on migraine medicine ongoing
EVERETT — More children may be susceptible to migraines than once thought.
A possible new drug to block migraine pain in adolescents is currently in study trials, and you can help participate.
Core Clinical Research, on Colby Avenue in Everett, is offering to diagnose pre-teens and teens aged 12 to 17 for migraines at no cost. It is offering free diagnoses as part of screening for participants for the drug study.
The study is for an adolescent version of rimegepant, a migraine medicine already available to adults. It’s an oral tablet that dissolves under the tongue that is taken when a migraine attack happens. The adult version is a FDA-approved prescription drug marketed as Nurtec ODT.
Dr. Jim Knutson, the lead drug study investigator for the Everett center, said during an interview that a greater number of children experience migraines than we may realize.
He is an addiction and child psychiatry specialist who has closely studied the central nervous system.
In children, migraines are similar to adults, such as being “sensitive to light, sensitive to sound and sensitive to movement,” Knutson said. For children, the migraines can last as long as adults.
People apply “a natural bias that as a kid, ‘you can’t have a migraine’,” but children as young as elementary age can, he said.
“And younger kids don’t have the language and maybe the skills to convey that information” as to why they feel ill, so migraines go undiagnosed, Knutson said.
Up to 18% of pediatric ER visits are from migraine headaches, Knutson said.
Males and females equally get migraines, but after puberty the split moves to 75% girls, 25% boys.
“Obviously there’s something in a puberty phase that seems to cause that,” Knutson said.
A large shift on identifying where migraines originate in the head is happening as we speak. For centuries, doctors thought vascular pressure problems caused the pulsating pain; treatments focused on constricting blood flow to relieve the pressure.
Now, though, doctors are starting to think migraines start in the nerves. At its core to blame is one large nerve around most of the face and cranium called the Trigeminal Nerve, which has the job of regulating pain.
“The bottom line is migraines are considered a brain disease versus a vascular disease,” Knutson said.
The medication uses a blocker to interrupt the pain signals of a migraine created when this nerve gets inflamed by a naturally occurring peptide.
The adolescent version is currently in phase three trials. Its maker, Biohaven Pharmaceuticals, wants to enroll upward of 1,440 youth.
Core Clinical research is the only office in Snohomish County taking patients for the study among the almost 100 offices nationally, according to Biohaven.
Potential participants are screened for three different things: One, a diagnosis for migraines; two, the frequency and severity of their migraines to see if they fit the study; and three, verification that the pain is due to migraines, said Core Clinical Research operations director Maria Golescu.
The drug trial is a double blind study where some are given the tablet and others the placebo.
“I want to emphasize, medicine is not the only answer. Sleep is important, and diet is important” as part of a healthy lifestyle to influence preventing migraines, Knutson said.
The study is recruiting for participants through 2022.
To get in the study, email gethelpnow@ccrtrial.com or call 425-443-9551 or visit www.pediatricmigrainestudy.com
