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Clinical Trials/EUCTR2008-007336-17-AT
EUCTR2008-007336-17-AT
Active, not recruiting
Not Applicable

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 sitesJuly 16, 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Medizinische Universität Wien, Uni. Klinik für Neurologie
Status
Active, not recruiting
Last Updated
13 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 16, 2009
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Medizinische Universität Wien, Uni. Klinik für Neurologie

Eligibility Criteria

Inclusion Criteria

  • \-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

Exclusion Criteria

  • \-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

Outcomes

Primary Outcomes

Not specified

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