JPRN-jRCT2080223667已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Chronic Migraine
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 571
研究概览
简要总结
Subcutaneous administration of fremanezumab for 3 months at 675 mg/3 months or 225 mg/1 month (following a loading dose of 675 mg) was effective in patients with chronic migraine (CM). Subjects reported an overall improvement in quality of life. No major safety issues were noted with fremanezumab treatment, and fremanezumab was well tolerated. Based on the above results, fremanezumab is expected to be a beneficial treatment option for patients with CM.
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 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 1 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
- •1. Patients who have previously failed (lack of efficacy) 2 or more of the clusters of the medications for treatment of migraine after use for at least 3 months at accepted migraine therapeutic doses
- •2. Patient suffers from unremitting headaches, defined as having headaches for more than 80% of the time that he/she is awake, and less than 4 days without headache per month. Daily headache is acceptable if the patient has headaches 80% or less of the time they are awake on most days.
- •3. 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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