Sugar Pill Beats Two Drugs in Migraine Trial for Children

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Neither of the two drugs used most frequently to prevent migraines in children is more effective than a sugar pill, according to a study published on Thursday in The New England Journal of Medicine.

Researchers stopped the large trial early, saying the evidence was clear even though the drugs — the antidepressant amitriptyline and the epilepsy drug topiramate — had been shown to prevent migraines in adults.

“The medication didn’t perform as well as we thought it would, and the placebo performed better than you would think,” said Scott Powers, the lead author of the study and a -director of the Headache Center at Cincinnati Children’s Hospital Medical Center.

A migraine is a neurological illness characterized by pulsating headache pain, sometimes accompanied by nausea, vomiting and sensitivity to light and noise.

It’s a common childhood condition. Up to 11 percent of 7- to 11-year-olds and 23 percent of 15-year-olds have migraines.

At 31 sites nationwide, 328 migraine sufferers aged 8 to 17 were randomly assigned to take amitriptyline, topiramate or a placebo pill for 24 weeks. Patients with episodic migraines (fewer than 15 headache days a month) and chronic migraines (15 or more headache days a month) were included.

The aim was to figure out which drug was more effective at reducing the number of headache days, and to gauge which one helped children to stop missing school or social activities.

As it turned out, there was no significant difference among the groups: 61 percent of the placebo group reduced their headache days by 50 percent or more, compared with 52 percent of the children given amitriptyline and 55 percent of those who took topiramate. And there was no significant difference among the three groups in reducing the school days or other activities missed.

The drugs also produced side effects in some children, such as fatigue, dry mouth, and tingling in their hands or feet. A few cases were more severe.

One child on topiramate attempted suicide. Three taking amitriptyline had mood changes; one told his mother he wanted to hurt himself, while another wrote suicide notes at school and was hospitalized.

Because of the side effects, Dr. Powers and his colleagues questioned whether the benefits of either drug outweighed its risks.

In 2014, the Food and Drug Administration approved topiramate for the prevention of migraine headaches in adolescents 12 to 17 who had fewer than 15 headache days a month. In light of the new study, Dr. Powers said he hoped that the F.D.A. and doctors would re-examine that decision.

Other experts were not yet ready to give up on drug treatment.

“Am I now going to feel obligated to tell patients that these drugs are no better than a placebo? No,” said Dr. Eugene R. Schnitzler, a professor of neurology and pediatrics at Loyola University Chicago Stritch School of Medicine.

“I’ll simply say, ‘We have data in adults that it’s effective, but less convincing data in children and adolescents.’”

Even if the drugs are not effective for children over all, “that doesn’t mean for any one individual, a drug might not work,” said Dr. David Gloss, a neurologist and a methodologist for the American Academy of Neurology.

A team of physicians, including Dr. Gloss, is revising the academy’s guidelines on pediatric migraines and planning to assess nondrug approaches.

A trial published last year found that taking amitriptyline and learning coping skills in a cognitive behavioral therapy program more effectively reduced headache days for chronic sufferers ages 10 to 17 than the drug given with only basic headache education.