Status:
COMPLETED
Cluster Headache Cortivazol Injection (CHCI)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Cluster Headache
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
the aim of tis study is to demonstrate the efficacy of cortivazol injections at the level of the greater occipital nerve to diminish the frequency of cluster headache (episodic or chronic) attacks dur...
Detailed Description
Cluster headache is characterized by unilateral attacks of severe periorbital pain accompanied by autonomic symptoms and restlessness. Though patients may respond to the standard prophylactic treatmen...
Eligibility Criteria
Inclusion
- patient age, man or woman whose age is between 18 and 65 included
- patient who signed a free express and informed consent
- patient with cluster headache, episodic or chronic according to the criteria of International Headache Society (ICHD-II)
- patient with more than two episodes of CH per day
- patient with a normal medical examination
Exclusion
- patient not affiliated with a social security scheme (or beneficiary entitled)
- patient with another diagnosis ICHD-II,and being unable to differentiate CH attacks from its other cranial pain
- patient of CH having started his episodic active period more than 30 days ago
- patient with a contra-indication to verapamil
- patient with a known allergy to cortivazol
- patient with anticoagulant therapy or having a bleeding disorder
- patient unable to complete the schedule crisis
- patient non-compliant or unable to follow the research protocol
- women without contraception, pregnant, or nursing
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00804895
Start Date
December 1 2008
End Date
October 1 2009
Last Update
November 27 2012
Active Locations (1)
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1
CHU Lariboisière, AP-HP, Centre des Urgences Céphalées (Emergency Headacha Center)
Paris, Île-de-France Region, France, 75010