Trip-tox Study. Analysis of the Efficacy and Satisfaction of Symptomatic Treatment With Triptans in Patients With Chronic Migraine Undergoing onabotulinumtoxinA Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change efficacy (Pain free at two hours )
研究概览
简要总结
Observational, longitudinal, prospective, prospective, comparative study of the effectiveness of triptans before and after onabotulintoxin A initiation in a single group of chronic migraine patients.
详细描述
Hypothesis In patients with chronic migraine the efficacy of triptans, previously taken by the patient for the migraine attack, is better and more satisfactory after starting treatment with onabotulinumtoxinA.
Objectives To analyze the efficacy and satisfaction of the triptan usually taken by the patient with chronic migraine before starting preventive treatment with onabotulinumtoxinA, at 4 months, after two sessions of Botox, and at 7 months of treatment, after three sessions of Botox.
Sample size n=100 patients with chronic migraine in whom treatment with onabotulinumtoxinA is indicated. The indication for Botox treatment will be performed as usual and the patient will take his usual triptan if he has a migraine attack, so there is no therapeutic modification in this study that could involve any bioethical issue.
All patients signed the informed consent and the study was approved by the Comitè d'Ètica de la Investigació amb Medicaments (CEIm) de l'Hospital de la Santa Creu i Sant Pau.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICHD-3 criteria for chronic migraine (code 1.3). See Table
- •Older than 18 years and younger than 65 years.
- •Migraine started in their lifetime before the age of 50 years.
- •Migraine of more than one year of evolution since diagnosis.
- •Normal cranial CT/MRI study.
- •Indication for treatment with Botox
- •Taking triptans as a rescue treatment for migraine attacks
排除标准
- •Pregnant women
- •Migraine of less than one year of evolution since diagnosis.
- •Pathologies that contraindicate the use of OnabotulinumtoxinA (myasthenia gravis, myopathies).
研究组 & 干预措施
Patients with chronic migraine
In the same group of patients, the response to triptans will be analyzed at 3 different times with respect to the start of treatment with onabotulinumtoxinA: before treatment, after 4 months and after 7 months of treatment.
干预措施: OnabotulinumtoxinA (Drug)
结局指标
主要结局
Change efficacy (Pain free at two hours )
时间窗: From baseline to 7 months
Percentage of patients who are completely free of pain after two hours of ingestion of their usual triptan.
Satisfaction (Likert scale 1-5)
时间窗: From baseline to 7 months
Satisfaction of treatment with triptans before and after treatment with OnabotulinumtoxinA
次要结局
- Pain free at one hour(4 and 7 months)
- Sustained pain-free(4 and 7 months)
- Headache relapse(4 and 7 months)