[Translation] A Phase III, Multicenter, Randomized, Double-Blind, Group Sequential, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rimegepant for the Treatment of Migraine (with or without aura) in Children and Adolescents ≥ 6 to < 18 Years of Age
主要目的:通过测量给药后 2 小时的疼痛消除情况,评价 Rimegepant 相比安慰剂在青少年人群(≥ 12 岁至 < 18 岁)偏头痛急性期治疗中的疗效。
次要目的:
通过测量给药后 2 小时的疼痛消除情况,评价 Rimegepant 相比安慰剂在儿童和青少年(≥ 6 岁至 < 18 岁)合并人群偏头痛急性期治疗中的疗效。
[Translation] Primary objective: To evaluate the efficacy of rimegepant versus placebo in the acute phase of migraine in the adolescent population (≥ 12 years to < 18 years) by measuring pain resolution at 2 hours post-dose.
Secondary purpose:
To evaluate the efficacy of rimegepant versus placebo in the acute phase of migraine in a combined population of children and adolescents (≥ 6 years to < 18 years) by measuring pain relief at 2 hours post-dose.