DRKS00025961招募中未知
Prevention of Medication Overuse (MO) and Medication Overuse Headache (MOH): A randomized, controlled, parallel, multicenter, prospective trial using a mobile application software - MOH
niversitätsklinikum Essen in Wahrnehmung der Aufgaben der Universität Duisburg-Essen, Campus Essen, Fachbereich Medizin; Institution: Institut für Medizinische Informatik, Biometrie und Epidemiologie0 个研究点目标入组 960 人开始时间: 2021年8月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 960
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1) Migraine patients: Patients with frequent episodic migraine (EM) (= 8-14 headache days/month, of which 4 fulfill IHS criteria for migraine) or chronic migraine (CM) (=15 headache days/month, of which 8 fulfill IHS criteria for migraine)
- •Post-MO(H)-Patients: Patients, who underwent treatment for MO(H) (initially = 15 headache days/month, intake of attack aborting medication on 10 or more or 15 or more days/month according to International Classification of Headache Disorders (ICHD-3) criteria of mediation overuse headache (MOH))
- •2) Owning a mobile device with iOS or Android system, which is able to run the App
- •3) Adults = 18 years
- •4) Written informed consent consistent with ICH-GCP (International Conference of Harmonization – Good Clinical Practice) guidelines and local laws signed prior to all study-related procedures
- •5) Compliance for using the App on = 80% days during the screening period
排除标准
- •1) Patients with concomitant primary headache disorders, other than EM or CM (except tension-type headache < 15 days/month)
- •2) Current MO upon the discretion of the treating physician (intake of attack aborting medication on =10 days/month within the last 3 months)
- •3) Co-morbidity interfering with the study outcomes upon the discretion of the treating physician
- •4) Intake of opioids on > 3 days/month
- •5) Regular intake (> 15 days/month) of (i) hypnotics, (ii) benzodiazepines as sedatives (tranquillizer), (iii) antipsychotics (neuroleptics) in psychiatric indication
- •6) Parallel use of other migraine apps to track headache days and medication intake
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