Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 701
- 试验地点
- 1
- 主要终点
- Exposure Adjusted Incidence Rate of AE During Open-label Treatment Epoch Per 100 Subject Years
研究概览
简要总结
This is a 128-week open-label study to assess the long-term safety and tolerabilty of the monoclonal antibody erenumab in migraine patients.
详细描述
This was an open-label, multi-center, single arm study with flexible dosing allowing both dose adjustment and one drug holiday per patient.
The study design consisted of 3 parts:
- Screening Epoch (0 - 2 weeks): required for all patients to assess initial eligibility. Eligible patients came from study CAMG334ADE01 (NCT03828539).
- Open-label Treatment Epoch (128 weeks): Individual patients were treated for 128 weeks. In this open-label treatment phase, the erenumab dose could be adjusted from 70 mg to 140 mg or vice versa at the discretion of the physician at any scheduled study visit. Additionally, a voluntary single treatment interruption ('drug holiday') of up to 24 weeks (approximately six months) could be introduced after at least 12 weeks of treatment in the open-label Treatment Epoch.
- Follow-up Epoch (4 weeks): A Follow-Up Visit 4 weeks after the last regular study visit (8 weeks after last investigational medicinal product [IMP] application) was required as part of routine safety monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Erenumab
Erenumab dose could be adjusted from 70 mg to 140 mg or vice versa at the discretion of the physician at any scheduled study visit.
干预措施: Erenumab (Biological)
结局指标
主要结局
Exposure Adjusted Incidence Rate of AE During Open-label Treatment Epoch Per 100 Subject Years
时间窗: Up to 128 weeks
This outcome measure was calculated dividing the number of adverse events (AEs) by the total patient exposure time and standardizing it per 100 patient-years. Exact Pearson-Clopper confidence intervals for single proportions were calculated to evaluate the precision of the estimated parameter.
次要结局
- Proportion of Patients Discontinuing Open-label Treatment Epoch Due to AE(Up to 128 weeks)
- Proportion of Patients Discontinuing Open-label Treatment Epoch Due to Non-AE Reasons(Up to 128 weeks)