NCT02502123已完成不适用
Multi-Centre, Prospective, Observational Study of Patient Reported Outcomes in Patients Diagnosed With Chronic Migraine and Treated With OnabotulinumtoxinA for Injection (BOTOX®) (PREDICT)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 215
- 试验地点
- 15
- 主要终点
- Change from Baseline in Migraine-Specific Quality of Life (MSQ) at Treatment 4 Using a 6-Item Questionnaire
研究概览
简要总结
This study will prospectively assess long term heath related quality of life in chronic migraine patients currently being treated with OnabotulinumtoxinA for injection (BOTOX®) as standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic migraine eligible to receive treatment with onabotulinumtoxinA (BOTOX®) as standard of care.
排除标准
- •Diagnosis of hemiplegic migraine, basilar migraine, ophthalmoplegic migraine or migrainous infarction, chronic tension-type headache, hypnic headache, hemicrania continua or new daily persistent headache.
- •Patient who is currently taking or planning on taking opioid-containing products, barbiturates or combination for acute headache or pain condition.
- •Treatment with any other botulinum toxin product for any condition within 3 months of the screening visit.
- •Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function.
结局指标
主要结局
Change from Baseline in Migraine-Specific Quality of Life (MSQ) at Treatment 4 Using a 6-Item Questionnaire
时间窗: Baseline, Treatment 4 (approximately 24 Weeks)
次要结局
- Clinician's Global Impression of Change Using a 7-Point Scale(Up to 2 Years)
- Work Productivity and Activity Impairment Questionnaire: Specific Health Problem Before and After BOTOX® Consisting of 6-Items(Baseline, Up to 2 Years)
- Healthcare Resource Utilization Before and After BOTOX® using a 9-Item Questionnaire(Baseline, Up to 2 Years)
- BOTOX® Treatment Regimen for Chronic Migraine(Up to 2 Years)
- Headache Assessment from Patient Diary(2 Years)
- Change from Baseline in MSQ at Final Visit Using a 6-Item Questionnaire(Baseline, Final Visit (Up to 2 Years))
- Patient Global Assessment of Treatment Satisfaction with BOTOX® using a 3-Item Questionnaire(2 Years)
- Reasons Why Treatment with BOTOX® Stopped(Up to 2 Years)
- Change from Baseline in Beck Depression Inventory Scale at Final Visit Using a 21-Item Questionnaire(Baseline, Final Visit (Up to 2 Years))
研究者
研究点 (15)
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