2023-507096-21-00招募中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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 382
- 试验地点
- 55
- 主要终点
- Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
研究概览
简要总结
To evaluate the safety and tolerability of treatment with atogepant 60 mg once daily when administered over 156 weeks for the prevention of migraine in participants with CM or EM
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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 1
- •Participants with hypertension at Visit 1
- •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.
结局指标
主要结局
Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
次要结局
- Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator
- Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator
- Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator
- Percentage of Participants with Clinically Significant Laboratory values, ECG findings or Vital Sign measures as assessed by Investigator; and results of the CSSRS Scale.
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (55)
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