A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents >= 6 to <18 Years of Age (Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects)

Pfizer Japan Inc.0 个研究点目标入组 640 人开始时间: 2024年6月3日最近更新: 2024年8月21日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: Pfizer Japan Inc.
入组人数: 640
主要终点: Change from baseline in the mean number of migraine days per month

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

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: Prevention 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

•Inclusion Criteria:
•Subject has at least a 6 month history of migraine (with or without aura) and including the following:
•a. 14 or less headache days per month during the 3 month period prior to the Screening Visit
•b. 6 or more migraine days during the Observation Period
•c. 14 or less headache days during the Observation Period
•d. Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of >10 to <=50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit
•e. Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
•f. Migraine attacks, on average, lasting 4 - 72 hours if untreated
•g. Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects >= 6 to <18 years; subjects must be less than 18 at the time of signing assent / consent.
•Subjects must have a weight of >=40 kg (child cohort requirement >=15 kg) at the Screening Visit.

排除标准

•Exclusion Criteria:
•Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
•The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
•The subject has a history or diagnosis of complications of migraine
•The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
•The subject has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Subjects with a lifetime history of psychosis and/or mania are excluded.
•History of suicidal behavior or the subject is at risk of self-harm or harm to others.
•History of major psychiatric disorder.
•The subject has a current diagnosis or history of substance abuse
•The subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator's opinion, likely to affect central nervous system functioning.

结局指标

主要结局

Change from baseline in the mean number of migraine days per month

时间窗: 3 months (12 weeks)

Reduction from baseline in mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine

次要结局

Achievement of at least a 50% reduction from baseline in mean monthly migraine days(3 months (12 weeks))
Change from baseline in the mean number of migraine days per month in the first 4 weeks(Weeks 1 through 4 of treatment)
The mean change from baseline in the Pediatric Quality of Life (PedsQL TM) total score(Total score at week 12)
Change from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment phase(3 months (12 weeks))
Change from baseline on the proportion of subjects that have at least a 50% reduction in the mean number of moderate to severe migraine days per month(3 months (12 weeks))
Compare the use of acute migraine-specific medications (triptans)(3 months (12 weeks))
Evaluate the safety and tolerability of rimegepant as a preventative treatment for migraine in children and adolescents(72 Weeks)
Evaluate the frequency of hepatic-related adverse events in subjects treated with rimegepant(72 Weeks)

研究者

发起方

Pfizer Japan Inc.

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