[Translation] A Phase III, multicenter, randomized, double-blind, group sequential, placebo-controlled study to evaluate the efficacy and safety of remegipam in the treatment of migraine (with or without aura) in children and adolescents aged ≥ 6 years to < 18 years
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 compared to placebo in the acute treatment of migraine in adolescents (≥ 12 years to < 18 years) by measuring pain freedom 2 hours after dosing.
Secondary objective:
To evaluate the efficacy of rimegepant compared to placebo in the acute treatment of migraine in a combined population of children and adolescents (≥ 6 years to < 18 years) by measuring pain freedom 2 hours after dosing.