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临床试验/EUCTR2008-007336-17-AT
EUCTR2008-007336-17-AT进行中(未招募)不适用

Blockade of the greater occipital nerve in frequent migraine and medication-overuse headache - a double-blinded, randomized, controlled trial

Medizinische Universität Wien, Uni. Klinik für Neurologie0 个研究点开始时间: 2009年7月16日最近更新:
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试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • -Men or women, aged between 18 and 65 years
  • -Headache diagnoses
  • a)Study 1: Diagnosis of migraine without or with aura according to the criteria of ICHD-II (Tables 1 and 2) and eight or more days of migraine without aura or probable migraine without aura (Table 3) per month on average during the three months preceding study inclusion.
  • b) Study 2: Diagnosis of MOH according to the revised criteria by Silberstein et al. (ICHD-IIR)
  • -Prophylactic therapy of headache: No prophylactic medication and no non-pharmacological headache prophylaxis in the previous three months OR stable prophylactic therapy for three months continued without change throughout the entire study period.
  • -Written informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 158
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • -Other headache disorders except tension-type headache
  • -Lifetime history of moderate or severe traumatic brain injury or any other cerebral disorder
  • -Mild traumatic brain injury in the previous year
  • -Substance abuse and medication overuse:
  • Study 1: Lifetime history of substance abuse and medication overuse as defined by Silberstein et al. in the previous year.
  • Study 2: Lifetime history of substance abuse except overuse of acute headache medication. Unsuccessful withdrawal therapy for MOH in the previous year. Current overuse of opioids or benzodiazepines
  • -Diabetes mellitus
  • -Known Glaucoma
  • -Uncontrolled hypertension
  • -Known osteoporosis
  • -Gastral or duodenal ulcer in the previous year
  • -Severe liver disease
  • -Obesity (BMI>30)
  • -Current treatment with corticosteroids
  • -Pregnancy or breastfeeding
  • -Change of prophylactic headache treatment in past 8 weeks

研究者

发起方
Medizinische Universität Wien, Uni. Klinik für Neurologie

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