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临床试验/NCT03606356
NCT03606356已完成4 期

Sustained onabotulinumtoxinA Therapeutic Benefits in Patients With Chronic Migraine Over 3 Years of Treatment. A

Corfu Headache Clinic0 个研究点目标入组 56 人开始时间: 2015年4月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
56
主要终点
Change in the mean number of monthly headaches

研究概览

简要总结

To assess whether there is a sustained benefit and good safety with repeated onabotulinumtoxinA sessions in chronic migraine over more than three years of treatment.

We prospectively enrolled 65 chronic migraine patients, who were classified as responders after three sessions of onabotulinumtoxin A and were eligible to further continue treatment.

详细描述

Evidence on whether the therapeutic effect and good safety profile of onabotulinumtoxinA (Botox®) in chronic migraine (CM) patients is maintained over long term treatment is still limited. This study aims at assessing whether there is a sustained benefit and good safety with repeated onabotulinumtoxin A sessions in CM over more than three years of treatment.

This study prospectively enrolled 65 CM patients, who were classified as responders after three sessions of onabotulinumtoxinA and were eligible to further continue treatment. Data documenting longitudinal changes from the trimester after the third onabotulinumtoxinA administration (T1) to the trimester after completing two years of treatment (T2) and eventually to the trimester after completing three years of treatment (T3) in (i) mean number of monthly headache days (ii) migraine severity as expressed by the mean number of days with peak headache intensity of >4/10, and (iii) mean number of days with use of any acute headache medication, were prospectively collected from patients' headache diaries.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with chronic migraine according to IHC-III with or without medication overuse.
  • Responders defined as patients that after 3 sessions of treatment with onabutulinum toxin A, having experienced a ≥50% reduction in their average monthly migraine days

排除标准

  • 未提供

结局指标

主要结局

Change in the mean number of monthly headaches

时间窗: 3 years

Change in the mean number of monthly headache days, from the third administration (months 10 to 12; T1) to the period after three years of treatment (months 37-39; T3)

次要结局

未报告次要终点

研究者

发起方
Corfu Headache Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

KONSTANTINOS SPINGOS

Konstantinos Spingos MD, Neurologist

Corfu Headache Clinic

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