Investigators found that zonisamide was associated with a reduction in monthly migraine days for pediatric populations.
In preliminary study results, zonisamide, a drug currently approved for seizures, demonstrated an association in reduced migraine days for children and adolescents, according to data that will be presented at the American Academy of Neurology’s 77th Annual Meeting.1
Zonisamide prophylaxis had an association with the reduction in headache days per month for pediatric patients who have migraine. | Image Credit: peopleimages.com | stock.adobe.com
“Migraine disease is debilitating and can lead to kids having to miss school and other activities,” Anisa Kelley, MD, of Northwestern University Feinberg School of Medicine in Chicago, said in a news release.1 “Currently, there is only one FDA-approved migraine preventative medication for this age group. Our results are encouraging, showing zonisamide may be another option for reducing migraine attacks.”
Investigators aimed to determine if zonisamide prophylaxis had an association with the reduction in headache days per month for pediatric patients who have migraine. Zonisamide has been used off-label for the prevention of migraine in this patient population, but the efficacy has not been well studied, according to the authors. The study was retrospective in nature and included patients with migraine using zonisamide. Those who had seizure disorder, used the drug for less than 6 weeks, or had unclear documentation of headache days were excluded by investigators.2
Investigators included 256 patients, with 70% being female, and a median age of 15 years. Additionally, there were approximately 28% with intractable migraine, defined as migraine that was unsuccessfully treated with 2 or more previous medications. The results showed that, at the first follow-up, patients had a median decrease from 18 headache days per month to 6 after zonisamide initiation. Furthermore, patients that followed up within 2 to 6 months had the largest median decrease of 6 headache days per month, and the results were consistent for those who had intractable and non-intractable migraine.1,2
“It’s very exciting that we may have an effective way to treat difficult migraine disease in children and teens; however, it’s important to note that our study did have limitations,” Kelley said in the news release.1 “For instance, our study did not compare people taking the medication to people who did not take the medication. Future studies are needed with control groups to confirm our results.”
Zonisamide was first approved in March 2000 in capsule formulation as an adjunctive therapy for the treatment of partial seizures in adults with epilepsy. Following this approval, zonisamide oral suspension 100 mg/5 mL was approved as an adjunctive therapy for the treatment of partial seizures for patients older than 16 years with epilepsy in 2022. It became the first drug approved in oral liquid formulation.3,4
The new drug application for zonisamide was submitted in March 1997 and initially received a complete response action letter before the initial approval.3