Two Migraine Drugs for Adolescents Not More Effective Than Placebo

Adolescents reported a clinically important decrease in self-reported migraine days, regardless of treatment assignment, upon completing a randomized, double-masked comparative effectiveness trial. These findings, from a secondary analysis, were published in the journal Headache.

For the Childhood and Adolescent Migraine Prevention (CHAMP) study, researchers recruited 328 children and adolescents with migraine. The study participants were randomly assigned in a 2:2:1 ratio to receive amitriptyline, topiramate, or placebo for 24 weeks. In this secondary analysis, those that completed the CHAMP trial (n=175) were evaluated for changes in self-reported migraine days which were recorded in their daily headache diary.

The amitriptyline (n=77), topiramate (n=63), and placebo (n=35) trial completers were:

• mean age: 14.3±2.3, 14.7±2.4, and 14.6±2.0 years;
• 66%, 84%, and 83% girls
• 85%, 79%, and 83% White

At baseline, those that received amitriptyline, topiramate, and placebo self-reported an average of 12.4, 13.5, and 14.2 headache days per month, respectively. After treatment, the number of days reported decreased to 6.1, 6.9, and 8.3 days, respectively.

Similar trends in the number of migraine days at baseline and during treatment were observed among amitriptyline (mean, 6.6 vs 2.9 days), topiramate (mean, 7.4 vs 3.6 days), and placebo (mean, 7.7 vs 3.8 days) recipients, and nosology-derived (non-aura) migraine days among amitriptyline (mean, 6.3 vs 2.8 days), topiramate (mean, 6.8 vs 3.1 days), and placebo (mean, 7.0 vs 3.7 days) recipients, respectively.

Compared with those who received placebo, the change in self-reported outcomes did not differ among amitriptyline (estimate, -0.17; P =.550) or topiramate (estimate, -0.17; P =.484) recipients.

Self-reported migraine days correlated with days with nosology-derived migraine at baseline (r, 0.73; P <.001) and during treatment (r, 0.83; P <.001), indicating that this age group of patients were proficient at differentiating between different types of migraine and headache.

Study limitations included the post-hoc design and the fact that most of the adolescents who completed treatment were girls who were White.

Researchers did not find statistically significant differences in self-reported migraine days among participants who received amitriptyline, topiramate, or placebo, and completed the trial.

“These findings suggest that pediatric patients with episodic and chronic migraine are fairly accurate in their ability to report about their ‘bad’ headache days, which typically include numerous migraine features,” the researchers concluded.

This article originally appeared on Clinical Pain Advisor