Cluster Headache Cortivazol Injection (CHCI)

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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 during an active period. Injections will be used in adjunct with oral verapamil.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Cortivazol; Verapamil

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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