Cluster Headache Cortivazol Injection (CHCI)

Phase 2/3 Completed 43 enrolled Assistance Publique - Hôpitaux de Paris

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2008-12
Primary completion: 2009-10
Completion: 2009-10

Outcome

Met primary endpoint

paper 20 of 21 patients who received cortivazol had a mean of two or fewer daily attacks after injections compared with 12 of 22 controls PMID 21903477 ↗

paper odds ratio 14·5, 95% CI 1·8-116·9; p=0·012 PMID 21903477 ↗

Publications

Results Leroux E, Valade D, Taifas I, Vicaut E, Chagnon M, Roos C, Ducros A. Suboccipital steroid injections for transitional treatment of patients with more than two cluster headache attacks per day: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2011 Oct;10(10):891-7. doi: 10.1016/S1474-4422(11)70186-7. Epub 2011 Sep 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	cortivazol	Other / unclassified	3.75 mg	Subcutaneous
Background	Verapamil	Other / unclassified	—	Oral