CTRI/2020/11/029312招募中3 期
Pediatric Options for Migraine Relief: A Randomized, Double-Blind,Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEERPEDS1 ?
Eli Lilly and Company India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Participants must have a history of migraine with or without aura as defined by International Headache Society International Classification of Headache Disorders, 3rd edition (ICHD-3) (ICHD-3 2018) diagnostic criteria 1.1 or 1.2.1 and meets the following criteria:
- •History of migraine attacks for more than 6 months
- •Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per month in the 2 months prior to screening visit
- •Duration of a typical untreated migraine attack (excluding sleep) is greater than or equal to 3 hours
- •Participant has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the investigator
- •Participant must be able to swallow a tablet
- •For participants taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to screening
- •Participants must weigh at least 15 kilograms (kg)
排除标准
- •Participants must not be pregnant or nursing
- •Participants must not have any acute, serious, or unstable medical condition
- •Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator
研究者
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