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
DrugsDiprophos
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.
Investigators
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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