NCT04686136已完成3 期
A Phase 3, Multicenter, Open-Label 156-Week Extension Study To Evaluate The Long-Term Safety And Tolerability Of Oral Atogepant For The Prevention Of Migraine In Participants With Chronic Or Episodic Migraine
AbbVie116 个研究点 分布在 3 个国家目标入组 596 人开始时间: 2021年2月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 596
- 试验地点
- 116
- 主要终点
- Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
研究概览
简要总结
This study will evaluate the Long-Term Safety and Tolerability of Atogepant 60 mg daily for the Prevention of Migraine in Participants with Chronic or Episodic Migraine
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Eligible participants who completed Visit 7, and Visit 8 if applicable, of Study 3101-303-002 or Study 3101-304-002 without significant protocol deviations and who did not experience an Adverse Event that may indicate an unacceptable safety risk.
排除标准
- •Participants requiring any medication, diet, or nonpharmacological treatment on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative.
- •Participants with an ECG indicating clinically significant abnormalities at Visit
- •Participants with hypertension at Visit
- •Participants with a significant risk of self-harm, or of harm to others; participants who report suicidal ideation with intent, with or without a plan, since the last visit, must be excluded.
- •Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
研究组 & 干预措施
Atogepant 60 mg
Experimental
Taken once daily
干预措施: Atogepant 60 mg (Drug)
结局指标
主要结局
Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
时间窗: 156 weeks
次要结局
- Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator(156 weeks)
- Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator(156 weeks)
- Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales(156 weeks)
- Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator(156 weeks)
研究者
研究点 (116)
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