Cluster Headache Cortivazol Injection (CHCI)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 3

Phase 2

Conditions

Cluster Headache

Treatments

Drug: ALTIM, cortivazol injections

Drug: PROAMP, subcutaneous serum physiological saline

Drug: Verapamil

Study type

Interventional

Funder types

Other

Identifiers

NCT00804895

P080602

Details and patient eligibility

About

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.

Full 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 treatment of verapamil, some are refractory and continue to suffer from numerous attacks, with a limit of two doses of subcutaneous sumatriptan per day. Some patients also have contra-indications to standard prophylactic or acute treatments. Other preventive treatments like systemic steroids, lithium and methysergide may cause significant side effects. We intend to show the efficacy of occipital nerve injections with cortivazol, in adjunct to verapamil, in cluster headache patients. We expect a diminution of attack frequency over two weeks, with a protocol of three injections separated by two or three days each. Tolerance and safety will be examined.

Enrollment

43 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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