Youths With Migraine Sustain Positive Outcomes Following Preventive Discontinuation

Findings from a survey study evaluating youths with longstanding and frequent migraines who participated in the Childhood and Adolescent Migraine Prevention (CHAMP) trial (NCT01581281) showed that many individuals maintained improvements in headache status for up to 3 years after treatment.

Senior author Andrew D. Hershey, MD, PhD, FAHS, Endowed Chair and director of neurology, Cincinnati Children’s Medical Center, and professor of pediatrics and neurology, University of Cincinnati College of Medicine, and colleagues used internet-based surveys collected from youth ages 8 to 17 years at 3, 6, 12, 18, 24, and 36 months after completion of the CHAMP trial. During the study, patients were randomized to amitriptyline, topiramate, or placebo, and assessed through the Pediatric Migraine Disability Assessment Scale (PedMIDAS), a standardized, validated disability questionnaire specific to youth with migraine. At the end of the trial, the study drug was stopped, and participants received clinical care of their choice thereafter.

In total, 205 youth (mean age, 14.2 years [standard deviation (SD), 2.3]; 139 girls [68%]) completed the 3-month follow-up survey questionnaires. At the end of the 3-year follow-up, participants experienced a mean of 6.1 (SD, 6.1) headache days per month, compared with 11.1 (SD, 6.0) headache days per month at baseline and 5.0 (SD, 5.7) headache days per month at the end of the CHAMP trial.

The retention rate of participants, as well as data completion, remained high at each time interval in the follow-up survey: 189 participants (92%) at month 6, 182 participants (88%) at month 12, 163 participants (80%) at month 18, 165 participants (80%) at month 24, and 155 participants (76%) at month 36.

"These results suggest that we should expect youth to improve, and that they continue to do well up to 3 years after pharmaceutical intervention,” Hershey et al wrote. “For clinicians, the implication of this unique trial follow-up survey study is that once an individual’s headache frequency and disability has improved, this change may be continued and sustained without future pharmacological treatment or health care utilization.”

At the end of the 3-year follow-up, the mean overall PedMIDAS disability score was 12.3 (SD, 20) compared with 40.9 (SD, 26.4) at baseline and 17.9 (SD, 22.1) at the end of the CHAMP trial. Additionally, longitudinal analyses showed amitriptyline and topiramate did not significantly explain intercept (amitriptyline: estimate, 6.11 [standard error (SE), 3.93]; P = .12; topiramate: estimate, 4.66 [SE, 3.95]; P = .24) or linear slope (amitriptyline: estimate, 0.25 [SE, 0.38]; P = .52; topiramate: estimate, –0.09; [SE, 0.39]; P = .82) random effects for PedMIDAS total score changes over time.

The use of migraine preventive medications varied at each of the follow-up time points. At the 3-month survey, topiramate was the most used prescription drug, taken in 6 of 78 participants (8%). No participants reported any preventive prescription drug use at the 6-month time point. Notably, only 1 out of 153 participants (1%) reported any preventive prescription drug use at the 3-year survey.