A 24-month, Prospective, Non-interventional Study to Describe the Long Term, Real-Life Use of BOTOX® for the Symptomatic Treatment of Adults With Chronic Migraine, Measuring Healthcare Resource Utilization, and Patient Reported Outcomes Observed in Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 641
- 试验地点
- 77
- 主要终点
- Mean Number of Days of Headache-related Hospital Admissions
研究概览
简要总结
This is an observational study to describe the long term use of Onabotulinumtoxin A (BOTOX®) as prescribed by the physician for headache prophylaxis in adults with chronic migraine. All treatment decisions lie with the physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Prescribed BOTOX® for the prophylaxis of headaches.
排除标准
- •Received treatment with any botulinum toxin Type A serotype in the last 26 weeks
- •Current participation in Allergan's Botox Chronic Migraine Post-Authorisation Safety Study (protocol 191622-110).
研究组 & 干预措施
BOTOX®
BOTOX® (botulinum toxin Type A) administered according to physician prescription for the treatment of chronic migraine; all treatment decisions lie with the physician.
干预措施: botulinum toxin Type A (Drug)
结局指标
主要结局
Mean Number of Days of Headache-related Hospital Admissions
时间窗: Baseline (previous 3 months prior to first dose of BOTOX@) to FU last [median 21.20 months]
The number of admission days is presented as the mean, normalized to a period of 90 days. The Baseline value included admissions during the last 3 months prior to the baseline visit (first administration of BOTOX®); the Last Follow-up value included admissions since the second-to-last visit.
Percentage of Participants Admitted to the Hospital for Headache
时间窗: Baseline (previous 3 months prior to first dose of BOTOX®) and Last Follow-up Visit (FU last) [median 21.20 months]
The Baseline value included participants who had been admitted to the hospital for headache in the last 3 months prior to the baseline visit (first administration of BOTOX®); the Last Follow-up value included participants who been admitted to the hospital for headache since the previous visit.
Percentage of Participants Who Visited Any Healthcare Professional (HCP)
时间窗: Baseline (previous 3 months prior to first dose of BOTOX®) to FU last [median 21.20 months]
The Baseline value included participants who had visited an HCP in the last 3 months prior to the baseline visit (first administration of Botox); the value for FU last included participants who visited an HCP since the second-to-last visit.
次要结局
- Change From Baseline in Migraine-Specific Quality of Life Questionnaire (MSQ) Score(Baseline to Last Administration of BOTOX® (ADM last) [median 20.30 months])
- Change From Baseline in the EQ-5D Questionnaire Total Score(Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months])
- Change From Baseline in the Health State Score of the EQ-5D Questionnaire(Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months])
- Change From Baseline in the Number of Headache Days(Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months])
- Percentage of Participants With Good or Very Good Responses on the 4-Point Treatment Satisfaction Scale(ADM last [median 20.30 months])