OnaBotulinumtoxin-A Effectiveness Evaluation in Chronic Migraine Patients With Short or Long Disease History: an Italian Multicentric Study (the BACH Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 115
- 试验地点
- 6
- 主要终点
- Monthly Migraine Days (MMD), Monthly Headache Days (MHD)
研究概览
简要总结
The goal of this observational prospective multicentric study, 12 months duration is to investigate whether the history of Chronic Migraine and, more precisely, its duration for over or less than 10 years, can predict OBT-A treatment effectiveness.
Since CM patients may have a complex psychopathological profile and psychiatric symptoms represent a bad prognostic factor influencing treatment effectiveness, the present study will also aim at evaluating if the psychopathological profile of the enrolled patients may influence the outcome.
详细描述
Onabotulinumtoxin-A (OBT-A) is a worldwide approved preventive treatment for patients suffering from Chronic Migraine (CM, 1.3, ICHD III 2018). Its effectiveness in reducing headache frequency and disability has been demonstrated by two well-designed phase III clinical trials, PREEMPT 1 and 2 and, more recently, by some real-life studies.
However, the use of OBT-A in the real world clinical practice has been still raising some issues: i.e. searching for more adequate patients' selection, when discontinuing the OBT-A treatment and when resuming it, finding associated patients' psychopathological profile possibly influencing the treatment, and so on. Moreover, finding some indicators of good or bad prognosis coming from OBT-A real-life experience could be of help for the clinicians to individuate the best candidates to the treatment.
The aim of the present study is mainly to investigate whether the history of Chronic Migraine and, more precisely, its duration for over or less than 10 years, can predict OBT-A treatment effectiveness. In other words, the study will aim to establish whether starting OBT-A treatment earlier in CM patients' life could make it more effective.
Since psychiatric symptoms may represent prognostic factors influencing treatment effectiveness, the present study will also aim at evaluating if the psychopathological profile of the enrolled patients may influence the outcome.
Consecutive CM patients treated in Italian tertiary level Headache Centers and classified according to CM history (shorter/longer than 10 years) will be enrolled.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years-old
- •Chronic Migraine defined according to 1.3 ICHD-3
- •Informed consent
排除标准
- •secondary headache
- •Onabotulinumtoxin-A in the previous 3 months
- •pregnancy or breastfeeding
- •detoxification protocol for Medication Overuse Headache in the last 6 months
研究组 & 干预措施
Group1 (>=10years) and Group1 (<10years)
Patients will be divided into 2 groups according to their CM history (duration): A) those from 1 to 9 years and B) those with 10 or more years of CM history.
干预措施: OnabotulinumtoxinA OBT-A (Drug)
结局指标
主要结局
Monthly Migraine Days (MMD), Monthly Headache Days (MHD)
时间窗: baseline to months 6 through 12
Change in the mean number of MMD (and MHD) from baseline to months 6 through 12 between groups
次要结局
- Number of monthly acute medications (MAM)(from baseline to months 6 through 12 between groups)
- Pain quality score, the 6-point Behavioral Rating Scale (BRS-6)(from baseline to months 6 through 12 between groups)
- Disability score, 6-item Headache Impact Test(from baseline to months 6 through 12 between groups)
- Psychological profile in terms of Beck Depression Inventory-II Edition, BDI-2(from baseline to months 6 through 12 between groups)
- Pain intensity score, Present Pain Intensity PPI(from baseline to months 6 through 12 between groups)
- 50% or greater reduction in monthly migraine days (MMD)(from baseline to months 6 through 12 between groups)
- Pain intensity score, Numerical Rating Score NRS(from baseline to months 6 through 12 between groups)
- Disability score, Migraine Disability Assessment MIDAS questionnaire(from baseline to months 6 through 12 between groups)
- Psychological profile in terms of Trait subtest of State-Trait Anxiety Inventory (STAI)(from baseline to months 6 through 12 between groups)
- Psychological profile in terms of Toronto Alexithymia Scale TAS-20(from baseline to months 6 through 12 between groups)
- Pain quality score, the short-form McGill pain questionnaire SF-MPQ(from baseline to months 6 through 12 between groups)