NCT04743141招募中3 期
Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute Treatment of Migraine (With or Without Aura) 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
- 600
- 试验地点
- 237
- 主要终点
- The frequency and severity of on-treatment and treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, clinically significant lab abnormalities
研究概览
简要总结
The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to < 18 years of age).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •History of migraine (with or without aura) for ≥ 6 months before Screening.
- •History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening.
- •1 or more migraine days requiring treatment during the Observation Phase.
- •Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit.
- •Ability to distinguish between migraine and other types of headaches.
- •Weight > 15 kg. For EU countries only: Participants 12 to < 18 years of age must have a body weight of >25kg.
- •Adequate venous access for blood sampling.
- •Male and female participants 6 to < 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit).
排除标准
- •History of cluster headache or hemiplegic migraine headache.
- •Confounding and clinically significant pain syndrome.
- •Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and/or mania are excluded).
- •History of suicidal behavior or at risk of self-harm/harm to others.
- •History of major psychiatric disorder.
- •Current diagnosis or history of substance abuse
- •Reported current use of or tested positive at Screening for drugs of abuse.
研究组 & 干预措施
Active
Experimental
rimegepant 75 mg, 50 mg or 35 mg ODT
干预措施: Rimegepant (PF-07899801) (Drug)
结局指标
主要结局
The frequency and severity of on-treatment and treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, clinically significant lab abnormalities
时间窗: 58 weeks
To evaluate the safety and tolerability of rimegepant in children and adolescents (6 to \< 18 years of age).
次要结局
- The frequency and severity of hepatic-related adverse events and frequency of hepatic-related adverse events leading to treatment discontinuation(58 weeks)
研究者
研究点 (237)
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