JPRN-jRCT2080223670已完成3 期
A Multicenter, Randomized, Open-label Trial Evaluating the Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
Subcutaneous administration of fremanezumab at 675 mg/3 months or 225 mg/1 month in patients with chronic migraine or episodic migraine reduced the number of migraine days and the number of headache days of at least moderate severity from 1 month after initial administration, and this effect was maintained throughout the treatment period. No major safety issues were noted with long-term administration, and fremanezumab was confirmed to be well tolerated.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •1. Patient has a history of migraine (according to The International Classification of Headache Disorders, third edition [beta version] criteria) or clinical judgment suggests a migraine diagnosis
- •2. Patient fulfills the criteria for Chronic migraine or Episodic migraine in baseline information collected during the 28 day screening period
- •3. Not using preventive migraine medications for migraine or other medical conditions or using no
- •more than 2 preventive migraine medication for migraine or other medical conditions if the dose and regimen have been stable for at least 2 months prior to giving informed consent.
- •4. Patient demonstrates compliance with the electronic headache diary during the screening period by entry of headache data on a minimum of 24 of 28 days and the entered data is judged appropriate by the investigator
排除标准
- •Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator
研究者
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