jRCT2031230579招募中不适用
Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (With or Without Aura) in Children and Adolescents >= 6 to < 18 Years of Age (Randomized Study in Children and Adolescents With Migraine: Acute Treatment)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,100
- 主要终点
- pain freedom
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 6age old over 至 17age old under（—）
- 性别
- All
入选标准
- •History of migraine (with or without aura) for > 6 months before Screening according to the IHS Classification ICHD-3 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant's parent(s)/legal representative(s).
- •History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting > 3 hours without treatment, and attacks occurring at intervals > 24 hours.
- •Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study.
- •a. Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists [biologic or small molecule], during the treatment phases.
- •b. Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.
- •c. Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.
- •Verbally distinguish between migraine and other types of headaches.
- •Participants must have a weight > 40 kg at the Screening Visit.
- •Adequate venous access for blood sampling.
- •Male and female participants >= 6 to < 18 years of age (participants must not reach their 18th birthday during the study).
排除标准
- •History of cluster headache or hemiplegic migraine headache.
- •Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.
- •Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania.
- •History of suicidal behavior or major psychiatric disorder.
- •Current diagnosis or history of substance abuse; positive drug test at Screening.
- •History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to affect central nervous system functioning.
- •Recent or planned surgery, requiring general anesthesia, <8 weeks prior to the Screening Visit.
- •Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).
- •Current diagnosis of viral hepatitis or a history of liver disease.
- •Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy
结局指标
主要结局
pain freedom
时间窗: 2 hours post-dose
To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of migraine in adolescent population (>= 12 to <18 years of age) as measured by pain freedom using the number of patients reporting no pain.
次要结局
- pain freedom in children and adolescents combined(2 hours post-dose)
- freedom from the most bothersome symptom (MBS) associated with migraine in adolescents(2 hours post-dose)
- probabilities of requiring rescue medication within in adolescents(Within 24 hours and 48 hours of initial treatment)
- pain freedom in children(2 hours post-dose)
- sustained pain freedom in adolescents(2 to 48 hours post-dose)
- ability to function normally as reported on the Functional Disability scale in adolescents(2 hours post-dose)
- freedom from the most bothersome symptom (MBS) associated with migraine in children and combined children and adolescents(2 hours post-dose)
- probabilities of requiring rescue medication in children and combined children and adolescents(Within 24 hours and 48 hours of initial treatment.)
- sustained pain freedom in children and combined children and adolescents(2 to 48 hours post-dose)
- freedom from photophobia in adolescents, children and combined children and adolescents(2 hours post-dose)
- freedom from phonophobia in adolescents, children and combined children and adolescents(2 hours post-dose)
- freedom from nausea in adolescents, children and combined children and adolescents(2 hours post-dose)
- pain relief in adolescents, children and combined children and adolescents(Time to patients first report of pain relief of none or mild post dose up to 48 hours.)
研究者
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