NCT03193346撤回3 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Allergan
- 主要终点
- Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with Week 24
研究概览
简要总结
This study will evaluate the efficacy and safety of BOTOX® (Botulinum Toxin Type A) compared with placebo as headache prophylaxis in Chinese participants 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
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic migraine prior to the baseline phase based on the revised criteria for chronic migraine listed in International Classification of Headache Disorders (ICHD)-3 beta (2013)
- •Fifteen or more headache days during the 4-week baseline phase, with each day consisting of 4 or more hours of continuous headache
- •Routine non-headache medications of stable dose and regimen for at least 1 month prior to the start of screening.
排除标准
- •Participants diagnosed with any of the following headache disorders: Familial hemiplegic migraine, Sporadic hemiplegic migraine, Migraine with brainstem aura, Migrainous infarction, Chronic tension-type headache, Hypnic headache, Hemicrania continua, New daily-persistent headache and Recurrent painful ophthalmoplegic neuropathy
- •Participants with a confirmed history of medication overuse headache
- •Participants with a diagnosis of retinal migraine, persistent aura without infarction or migraine-triggered seizure
- •Headache attributable to another disorder (eg, cervical dystonia, craniotomy, head/neck trauma)
- •Use of any headache prophylactic medication within 28 days prior to the start of the screening
- •Any medical condition that may put the patient at increased risk with exposure to Botulinum Toxin Type A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
- •Participants with a known or suspected Temporomandibular Disorder (TMD), including pain in or around the Temporomandibular Joint (TMJ)
- •Participants with a concurrent diagnosis of fibromyalgia
- •Previous treatment with botulinum toxin therapy for any reason, or immunization to any botulinum toxin serotype
- •Acupuncture, transcutaneous electrical nerve stimulation (TENS), cranial traction, nociceptive trigeminal inhibition or occipital nerve block treatments, or injection of anesthetics or steroids into the study target muscles within 28 days prior to the start of the screening
- •Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
研究组 & 干预措施
BOTOX®
Experimental
BOTOX® (botulinum toxin Type A) 155U to 195U intramuscular (IM) injections in head/neck areas at Day 0 and Week 12.
干预措施: botulinum toxin Type A (Biological)
Placebo
Placebo Comparator
Placebo matching BOTOX® [Sodium chloride 0.9 milligrams (mg)] IM injections in head/neck areas at Day 0 and Week 12.
干预措施: placebo (sodium chloride 0.9 mg) (Drug)
结局指标
主要结局
Change from Baseline in the Frequency of Headache Days during 28-Day Period Ending with Week 24
时间窗: Baseline, Week 24
Mean change from Baseline (28-days prior to first treatment) in frequency (number) of headache days during the 28-day period ending with Week 24. A headache day was defined as a calendar day \[00:00 to 23:59\] for which the participant reported ≥ 4 continuous hours of headache per patient diary.
次要结局
- Change from Baseline in the Frequency of Headache Days during 28-Day Period(Baseline, Weeks 4, 8, 12, 16 and 20)
- Change from Baseline in the Number of Moderate/Severe Headache Days during 28-Day Period(Baseline, Weeks 4, 8, 12, 16, 20 and 24)
- Change from Baseline in the Frequency of Migraine/Probable Migraine Days during 28-Day Period(Baseline, Weeks 4, 8, 12, 16, 20 and 24.)
- Change from Baseline in Total Cumulative Hours of Headache Days during 28-Day Period(Baseline, Weeks 4, 8, 12, 16, 20 and 24)
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