NCT05156398招募中3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 640
- 试验地点
- 174
- 主要终点
- Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to <18 years with episodic migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has at least a 6 month history of migraine (with or without aura) and including the following:
- •14 or less headache days per month during the 3 month period prior to the Screening Visit
- •6 or more migraine days during the Observation Period
- •14 or less headache days during the Observation Period
- •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
- •Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
- •Migraine attacks, on average, lasting 4 - 72 hours if untreated
- •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
- •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.
研究组 & 干预措施
Rimegepant / BHV3000
Active Comparator
Rimegepant 75mg or 50mg (2 X 25mg) ODT
干预措施: Rimegepant (Drug)
Matching Placebo
Placebo Comparator
Matching placebo 75mg or 50mg (2 X 25mg) ODT
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine
时间窗: 3 months (12 weeks)
Reduction from baseline in mean number of migraine days per month
次要结局
- Achievement of at least a 50% reduction from baseline in mean monthly migraine days over the course of the double-blind phase in adolescents with episodic migraine(3 months (12 weeks))
- Change from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.(3 months (12 weeks))
- Compare the use of acute migraine-specific medications (triptans) based on the change from baseline in monthly acute migraine specific medication 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 the double-blind treatment phase in adolescents with episodic migraine.(Weeks 1 through 4 of treatment)
- The mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score at Week 12 of the double-blind treatment phase in adolescents with episodic migraine.(Total score at week 12)
- 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))
- 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
研究点 (174)
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