EUCTR2019-004379-38-RO进行中(未招募)1 期
A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients with Migraine - PIONEER-PEDS2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 1,000
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
- •[1] Patient was between 6 and <18 years of age inclusive at the time of enrollment into Study LAHX or Study LAHV.
- •[2] The patient has a minimum body weight of 15 kg.
- •[3] The patient is able to swallow a tablet.
- •[4] For patients taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to Visit 1.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1000
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •[1] Patient is pregnant or breastfeeding.
- •[2] Patient has, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
- •[3] Patient has known allergies to lasmiditan, related compounds, or any components of the formulation.
- •[4] In the opinion of the investigator or sponsor, patient is unsuitable for inclusion in the study.
研究者
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