CTIS2022-501099-24-00招募中1 期
A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety of Atogepant in Pediatric Subjects 6 to 17 years of age with Episodic Migraine - M21-199
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 246
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
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •Participants must be between 6 and 17 years of age (inclusive), with a history of episodic migraine., The participant must have completed the lead-in Study M21-201, the pharmacokinetic (PK) substudy in Study M21-201, or completed the 4-week screening/baseline period and screen failed due to not meeting the number of migraine day requirements for the inclusion criteria in Study M21-201, and, in the judgment of the investigator, the participant is an appropriate candidate to be treated with a daily preventive migraine treatment with atogepant (not applicable for de novo migraine participants), Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs)., A history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3; 2018) for at least 6 months.
排除标准
- •History of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018)., Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018)., Have a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018)., Have any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular, or neurologic disease.
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