CTRI/2025/02/081278招募中3 期
An Interventional, Efficacy, and Safety, Phase 3, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension to Investigate Rimegepant in Migraine Prevention in Adolescents 12 to Less Than 18 Years of Age With Chronic Migraine
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer Inc.
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Mean change from the observation phase in the number of migraine days per month over the entire double blind treatment phase
研究概览
简要总结
Rimegepant has obtained approval in the United States (US), United Kingdom (UK), European Union (EU), and other countries for the acute treatment of migraine with and without aura in adults, and, in some countries, the preventive treatment of episodic migraine in adults. Currently, rimegepant is being studied for the acute treatment of migraine in children and adolescents, as well as for the prevention of migraine in children and adolescents with episodic migraine.
The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in adolescents of 12 to 18 years of age with chronic migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject has at least a 6 month history of migraine (with or without aura) and including the following:.
- •15 or more headache days per month during the 3 month period prior to the Screening Visit.
- •8 or more migraine days per month during the 3 month period prior to the Screening Visit.
- •15 or more headache days during the Observation Period.
- •8 or more migraine days during the OP.
- •Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches.
- •Migraine attacks, on average, lasting 4 to 72 hours if untreated.
排除标准
- •Target Disease Exclusion:.
- •Continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
- •Atypical migraine types, complications of a migraine, or a confounding and clinically significant pain syndrome that may interfere with the participant’s ability to participate in this study as assessed by the principal investigator (PI).
- •Any medical condition or laboratory abnormality, including any clinically significant out-of-range vital signs, that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study
- •Any current psychiatric condition that is uncontrolled and/or untreated.
- •Any “yes†response on the Columbia-Suicide Severity Rating Scale (C-SSRS) for the period of 30 days prior to Screening.
- •History of alcohol abuse and/or illicit drug use meeting Diagnostic and Statistical Manual-5 (DSM-5®)2 criteria for substance use disorder within 6 months of screening (excluding nicotine and caffeine).
- •Allergies and Adverse Drug Reactions:.
- •History of severe drug allergy (such as anaphylaxis, or known hypersensitivity or intolerance to rimegepant or its excipients).
结局指标
主要结局
Mean change from the observation phase in the number of migraine days per month over the entire double blind treatment phase
时间窗: 3 months or 12 weeks
次要结局
- Mean change from OP in number of moderate to severe headache days per months over entire DBT phase 1 to 12 weeks(1. Treatment effect of rimegepant relative to placebo in adolescent patients with chronic migraine in terms of difference in mean changes from OP in number of moderate or severe headache days per month over entire DBT Phase.)
- Percentage of participants with more than 50 percent reduction from the OP(The difference in the percentage of participants with more than 50 percent reduction from the OP)
- Mean change from baseline in the PedsQL 4.0 Generic core scales total score at week 2 of DBT phase(The difference in mean changes from baseline in the PedsQL total score at week 12 of the DBT phase.)
研究者
研究点 (7)
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