EUCTR2019-002201-22-DE进行中（未招募）1 期
Assessment of Prolonged safety and tOLerability of erenumab in migraine patients in a Long-term OpeN-label study (APOLLON) - APOLLO
ovartis Pharma GmbH0 个研究点目标入组 640 人开始时间: 2019年6月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 640
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patient is capable of understanding the nature, significance and implications of the clinical trial.
- •- Adults =18 years of age upon entry into screening
- •- Earliest time point for inclusion to this open-label study is 26 weeks after randomization to trial CAMG334ADE01:
- •a)Subjects who completed visit V199 in trial CAMG334ADE01 have to wait additional 2 weeks for down-titration of topiramate (doses 75 and 100 mg) and total elimination for topiramate (equals 26 weeks after randomization)
- •b)Subjects who discontinued their participation in CAMG334ADE01 before V199 have to wait until the planned V199 visit date and additional 2 weeks (26 weeks after randomization).
- •- Subjects who are deemed by the investigator to benefit from erenumab therapy
- •Other protocol-defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 608
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •- Patients who had to terminate the trial CAMG334ADE01 due to a protocol violation or due to a safety event.
- •- Use of a prophylactic migraine medication within five plasma clearance half-lives, or a device or procedure within one month prior to the start of the Open-label Treatment Epoch. This exclusion criteria does not apply to erenumab or topiramate administered within clinical trial CAMG334ADE01
- •- Any prior exposure to (investigational) prophylactic migraine products targeting the CGRP pathway, other than erenumab.
- •- Use of the following for any indication one month prior to the start of the Open-label Treatment Epoch:
- •a. Opioid- or butalbital-containing analgesics =4 days/month
- •Other protocol-defined exclusion criteria may apply.
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