EUCTR2020-002470-27-DK进行中（未招募）1 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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 670
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 639
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 31
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
研究者
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