Background
What do we already know about this topic?
- The CHAMP 24-week study was a Phase 3 randomized, double-blind, clinical trial evaluating amitriptyline (1 mg/kg QD) and topiramate (2 mg/kg QD) verus placebo across individuals with migraine, aged 8 to 17 years old (n=361).
- The primary outcome was a relative reduction of 50% or more in the number of headache days, and secondary outcomes were headache-related disability, headache days, number of trial completers, and serious adverse events that emerged during treatment.
- At 24-weeks, neither medication was superior to placebo in the reduction of headache days nor disability, and there were greater side effects with both medications.1
- Most youths showed a notable reduction in headache frequency, even if they didn’t meet the 50% reduction endpoint.
- The follow-up survey examined headache days and disability at 3, 6, 12, 18, 24, and 36 months post-CHAMP.
How was this study conducted?
- Internet-based survey reporting headache days, PedMIDAS disability assessment and use of prescription migraine prevention medication.
- Surveyed youths diagnosed with migraine (n=205) from the original CHAMP study, blind to the treatment previously received, at 3-months, then 6-month intervals across 3-years.
- Since the CHAMP study, subjects had freely chosen their own type of medical care.