Phase 4, Open-label Study to Evaluate Treatment Satisfaction With Erenumab in Patients With Migraine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 240
- 试验地点
- 42
- 主要终点
- Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by SoC
研究概览
简要总结
The main purpose of this study is to evaluate the effect of erenumab on medication-specific treatment satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Participant has provided informed consent
- •History of migraine (with or without aura) for ≥ 12 months before screening
- •≥ 4 migraine days per month on average across the 3 months prior to screening
- •Treatment with 1 oral migraine preventive medication and/or concomitant use of OnabotulinumtoxinA injections for migraine prevention.
- •Participant reports to their provider intolerance or insufficient response with their current preventative treatment
排除标准
- •History of cluster headache or hemiplegic migraine headache
- •Unable to differentiate migraine from other headaches
- •Evidence of substance-related disorders
- •Active chronic pain syndromes (eg, fibromyalgia and chronic pelvic pain)
- •No therapeutic response with > 3 migraine preventive medication categories
- •Used a prohibited medication, device, or procedure
- •Other clinically significant disorder, condition, or disease
研究组 & 干预措施
Erenumab
干预措施: Erenumab (Drug)
结局指标
主要结局
Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by SoC
时间窗: Baseline and Week 24
The TSQM version 1.4 is a 14-item instrument designed to measure important dimensions of participants' experiences with their medication. It has 4 domains: effectiveness, side effects, convenience, and overall satisfaction. Overall satisfaction scores could range from 0 to 100, with higher scores indicating greater satisfaction. A positive change from Baseline represents an increase in overall medication satisfaction. Worst postbaseline value observed up to erenumab discontinuation was used for participants who discontinued erenumab due to lack of efficacy or adverse event; missing value used for participants who discontinued erenumab due to other reasons.
Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by Migraine Type
时间窗: Baseline and Week 24
The TSQM version 1.4 is a 14-item instrument designed to measure important dimensions of participants' experiences with their medication. It has 4 domains: effectiveness, side effects, convenience, and overall satisfaction. Overall satisfaction scores could range from 0 to 100, with higher scores indicating greater satisfaction. A positive change from Baseline represents an increase in overall medication satisfaction. Worst postbaseline value observed up to erenumab discontinuation was used for participants who discontinued erenumab due to lack of efficacy or adverse event; missing value used for participants who discontinued erenumab due to other reasons.
次要结局
- Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC(Week 24)
- GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC(Baseline up to Week 24)
- Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type(Week 24)
- GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type(Baseline up to Week 24)
- Observed Data: Percentage of Participants Reporting Improvement in the Migraine Global Impression Item (mGI-I) at Week 24 by SoC(Baseline and Week 24)
- GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by SoC(Baseline up to Week 24)
- Observed Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type(Baseline and Week 24)
- GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type(Baseline up to Week 24)
- Mean Change From Baseline in Domain Scores as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24 by SoC(Baseline and Week 24)
- Mean Change From Baseline in Domain Scores as Measured by the MFIQ at Week 24 by Migraine Type(Baseline and Week 24)