NCT00804895

Cluster Headache Cortivazol Injection (CHCI)

A Double Blind Randomized Controlled Trial of Greater Occipital Nerve Infiltration in Cluster Headache

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Cluster Headache

Interventions

Type	Name	Description
DRUG	ALTIM, cortivazol injections	ALTIM, cortivazol in greater occipital nerve injection separated by 2 or 3 days each.
DRUG	PROAMP, subcutaneous serum physiological saline	Three injections will be performed at the level of the greater occipital nerve with a suboccipital approach. Injection will be separated by two or three days each.
DRUG	Verapamil	standard prophylactic treatment

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-12-09
• Last updated: 2012-11-27

Locations

1 site across 1 country: France