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临床试验/DRKS00016328
DRKS00016328招募中2 期

Smartphone assisted migraine therapy - SMARTGEM

Charité Campus Charité Mitte0 个研究点目标入组 1,200 人开始时间: 2018年12月17日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
1,200

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
Open (masking not used)

入排标准

年龄范围
18 Years 至 99 Years(—)
性别
All

入选标准

  • First presentation in the headache outpatient department of the Charité Universitätsmedizn Berlin, Universitätsmedizin Rostock or Universitätsklinik Halle
  • - Diagnosis of episodic migraine with at least 5 migraine days / month or chronic migraine with or without aura according to the IHCD-3 criteria
  • - onset of migraine before the age of 50 and lasting for at least a year
  • - Own an Android or iOS enabled smartphone with mobile internet access and basic understanding of apps
  • - Ability and readiness to give a written informed consent
  • - Insured with a statutory health insurance
  • - The M-sense calendar has been completed with a compliance rate of at least 80% in the last 28 days prior to inclusion
  • - The subject documented at least 5 migraine days in the baseline phase with M-sense over a period of 28 days

排除标准

  • Previous use of the M-sense active app more than 14 days
  • Diagnosis of another headache disease besides migraine (all secondary headaches and primary headaches of the ICHD-3 group 3 and 4) Tension-type headaches (ICHD-3 group 2) are allowed, provided they do not account for more than 50% of headache days / month
  • Previous or current drug or alcohol abuse within one year prior to visit (excessive or compulsory use as determined by the study physician)
  • Current use of medication that indicates evidence of abuse or dependency (exception: analgesic or triptan overuse)
  • Taking more than 3 doses / month of opioids or barbiturates

研究者

发起方
Charité Campus Charité Mitte

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