It's very difficult to watch our children suffer when they have a Migraine attack. What makes this especially discouraging is that there is little we can do to alleviate their pain and other symptoms. Axert is FDA-approved for children who are 12- to 17-years-old in the United States, and sumatriptan nasal spray is used in the European Union. As the numbers of diagnosed Migraineurs continue to rise in the pediatric community, it's becoming apparent more needs to be done to provide relief for these patients. A recent study took a look to see if a single dose of Maxalt orally disintegrating tablets would be well tolerated in children with Migraine.
How the study was conducted:
- This was a small study conducted at two United States centers with 31 children, 6- to 17-years-old.
- The study was to investigate the tolerability of a single dose of Maxalt orally disintegrating tablets.
- These children with Migraine were split into two groups by weight and age.
- Children who weighed less than 88 pounds were given 5 mg of Maxalt (6- to 12-years-old) or the placebo.
- Children who weighed over 88 pounds (6- to 17-years-old) took 10 mg of Maxalt or the placebo.
- The participants had at least a six-month period of Migraine attacks based on The International Headache Society's International Classification of Headache Disorders, 2nd Edition, (ICHD-II) but were excluded if they:
- they took any medication, over-the-counter or prescription that could not be stopped two weeks before the study began.
- used Imitrex or other triptans.
- took monoamine oxidase inhibitors (MAOI's) or selective serotonin reuptake inhibitors (SSRI's).
- had Hemiplegic Migraine, Basilar-Type Migraine, syncope, Kawaski's disease, phenylketonuria or any condition the researchers felt would impact the study.
- had any major drug allergies or any reactions to investigational drugs.
- This was a study to determine how well the children tolerated Maxalt, not how well it worked for them, so a single dose was administered to all the children at the same time in a clinic setting rather than providing the medication to be taken during a Migraine attack.
Results of the study:
- Two children complained of headache.
- One child experienced each of the following:
- an increase in blood pressure,
- vague visual issues,
- extreme sleepiness and
- Each child recovered from these events.
- Researchers felt these symptoms were related to the study drug.
- A single dose of Maxalt once a day was tolerated nicely in this population.
- Children who were getting 5mg of Maxalt based on weight were possibly under dosed.
It's pretty clear there isn't enough help out there for children who have Migraine disease, but thankfully we can add Maxalt to their Migraine management plan. In late December, 2011, the FDA approved it for children 6- to 17-years-old. Axert is approved for older children (ages 12- to 17-years-old), but Maxalt is the first triptan approved for younger children. The FDA took a step in the right direction by approving a supplemental new drug application for Maxalt to extend its use for children with Migraine, ages 6- to 17-years-old. Hopefully my grandchildren (if Migraineurs) will be able to benefit from this research.