Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 52
- 主要终点
- Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score
研究概览
简要总结
This study will evaluate the use of the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire in assessing the impact and benefit of treatment with onabotulinumtoxinA (BOTOX®) in adults 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of chronic migraine for at least 6 months prior to the screening visit
- •Fifteen or more headache days during the 4-week screening period (≥4 headache episodes lasting ≥4 hours and ≥50 % of headache days are migraine)
排除标准
- •Conditions causing chronic facial pain such as Temporomandibular Disorder (TMD) and fibromyalgia
- •Use of headache prophylaxis medication within 4 weeks of the screening visit
- •Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
- •Previous use of any botulinum toxin of any serotype for any reason
- •Skin infections or acne that would interfere with the injection sites
- •Acupuncture, transcutaneous electrical nerve stimulation (TENS), cranial traction, dental splints for headache, nociceptive trigeminal inhibition, occipital nerve block treatments, or injection of anesthetics/steroids within 4 weeks of screening.
研究组 & 干预措施
OnabotulinumtoxinA
OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
干预措施: OnabotulinumtoxinA (Biological)
Placebo (Normal saline)
Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
干预措施: Normal saline (placebo) (Drug)
结局指标
主要结局
Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score
时间窗: Baseline, Week 24
The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The total score ranged from 0 (lower impact chronic migraine) to 100 (highest impact chronic migraine). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.
次要结局
- Change From Baseline in the Symptom Severity Score (SSS) Subdomain of the Assessment of Chronic Migraine Symptoms (ACM-S) Questionnaire(Baseline, Week 24)
- Change From Baseline in the Symptom Experience Score (SES) Subdomain of the ACM-S Questionnaire(Baseline, Week 24)
- Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire(Baseline, Week 12, Week 22, Week 24)
- Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire(Baseline, Week 12, Week 22, Week 24)
- Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire(Baseline, Week 12, Week 22, Week 24)
- Change From Baseline in the Social Impact (SOC-I) Domain of the ACM-I Questionnaire(Baseline, Week 12, Week 22, Week 24)
- Change From Baseline in the Leisure Activities Impact (LEA-I) Domain of the ACM-I Questionnaire(Baseline, Week 12, Week 22, Week 24)
- Change From Baseline in the Household Activities Impact (HOS-I) Domain of the ACM-I Questionnaire(Baseline, Week 12, Week 22, Week 24)
- Change From Baseline in the Energy Impact (ENE-I) Domain of the ACM-I Questionnaire(Baseline, Week 12, Week 22, Week 24)
- Change From Baseline in the Cognitive Impact (COG-I) Domain of the ACM-I Questionnaire(Baseline, Week 12, Week 22, Week 24)
- Change From Baseline in the General Impact (GEN-I) Domain of the ACM-I Questionnaire(Baseline, Week 12, Week 22, Week 24)
- Change From Baseline in the Headache Impact Test-6 (HIT-6) Questionnaire Total Score(Baseline, Week 24)
- Change From Baseline in the Role Function-Restrictive (RR) Domain of the Migraine Specific Questionnaire (MSQ)(Baseline, Week 24)
- Change From Baseline in the Role Function-Preventive (RP) Domain of the MSQ(Baseline, Week 24)
- Change From Baseline in the Emotional Function (EF) Domain of the MSQ(Baseline, Week 24)