A Multicenter, Open-label Trial to Evaluate the Safety of TEV-48125 When Subcutaneously Self-administered in Migraine Patients at the Trial Site and at Home
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
研究概览
简要总结
This trial assesses the safety of TEV-48125 when subcutaneously self-administered in Japanese migraine patients using an autoinjector (AI) at home. Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses. The first dose will be self-administered at the trial site under the supervision of the investigator and the second dose will be self-administered at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a history of migraine (according to the ICHD-3 criteria) diagnosis for ≥12 months prior to giving informed consent.
- •Patient fulfills any of the migraine criteria(according to the ICHD-3 criteria) on ≥4 days in baseline information collected during the 28-day screening period
排除标准
- •History of hypersensitivity reactions to injected proteins, including monoclonal antibodies
- •Prior exposure to a monoclonal antibody targeting (CGRP) pathway meeting the following conditions:
- •Less than 5 months has passed since the final administration of AMG334, ALD304, or LY
- •Less than 1 year has passed since the final administration of TEV-48125
研究组 & 干预措施
Treatment: TEV-48125
干预措施: Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses. (Drug)
结局指标
主要结局
Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)
时间窗: [1] Baseline (Day 1) to Day 28, [2] Visit 3 (Day 29) up to end of treatment (Day 57)
* TEAEs were defined as AEs that started after the start of investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was worsening after the start of IMP treatment. * The number of subjects with TEAEs were provided by self-administration at the trial site and by self-administration at home. 1. For TEAEs following self-administration at the trial site, TEAEs that occurred after self-administration at the trial site (Baseline) but before self-administration at home (Visit 3) were tabulated. 2. For TEAEs following self-administration at home, TEAEs that occurred after self-administration at home but before the end of the trial were tabulated.
次要结局
- Number of Deficiencies With the AI Device(Baseline (Day 1) and Visit 3 (Day 29))
- Execution Status of Self-administration - Leakage of Drug Solution on the Skin(Baseline (Day 1) and Visit 3 (Day 29))
- Subject Compliance With the Self-administration Procedure(Baseline (Day 1) and Visit 3 (Day 29))
- Execution Status of Self-administration - Amount of Drug Solution Remaining in the AI(Baseline (Day 1) and Visit 3 (Day 29))