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The Placebo Responder Rate in Children and Adolescents
The key issue facing clinicians conducting clinical
trials for the acute treatment of migraine in the pediatric and
adolescent patients has been the high placebo responder rate.
While adult studies have been able to predictably yield a
placebo-response rate about 35%, pediatric trials typically
have demonstrated rates to be 50% or higher. Even the most
novice student of statistics can appreciate the challenge to
designing a study with an anticipated placebo response of greater
than 50% to 60%. To demonstrate efficacy with a 50+%
placebo-response rate, the differential between active and placebo
must be large. Unfortunately, reported studies have typical "active"
responder rate has been between 60% to 85%. The burden then falls
to the attainment of an "n" sufficient to detect a significant
difference. This becomes discouraging, cost-ineffective, and,
quite frankly, ponderous.
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