191622-103 BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Headache Prophylaxis in Adolescents (Children 12 to < 18 Years of Age) With Chronic Migraine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 125
- 试验地点
- 22
- 主要终点
- Change From Baseline in the Frequency of Headache Days
研究概览
简要总结
To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline) as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical history of chronic migraine for at least 6 months
- •15 or more headache days during a 4 week period
排除标准
- •Previous use of any botulinum toxin of any serotype for any reason
- •Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
- •Treatment of headache using acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints, or injection of anesthetics/steroids within 4 weeks prior to the week -4 screening visit
- •Use of any headache prophylaxis medication within 4 weeks prior to the week -4 screening visit
研究组 & 干预措施
Botulinum toxin type A Dose 1
Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.
干预措施: Botulinum toxin type A Dose 1 (Biological)
Botulinum toxin type A Dose 2
Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.
干预措施: Botulinum toxin type A Dose 2 (Biological)
Placebo (Normal Saline)
Placebo (Normal Saline) intramuscular injections into specified muscles.
干预措施: Placebo (Normal Saline) (Drug)
结局指标
主要结局
Change From Baseline in the Frequency of Headache Days
时间窗: Baseline, 12 Weeks
Change from baseline in the frequency of headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A headache day for a patient is defined as a calendar day with 1 or more total hours of headache as recorded by the patient in the electronic diary.
次要结局
- Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days(Baseline, 12 Weeks)
- Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment(12 Weeks)
- Change From Baseline in the Frequency of Severe Headache Days(Baseline, 12 Weeks)
- Change From Baseline in the Total Cumulative Hours of Headache on Headache Days(Baseline, 12 Weeks)