Cluster Headache Cortivazol Injection (CHCI)

Phase 2

Completed

• Conditions: Cluster Headache
• Interventions: Drug: ALTIM, cortivazol injections; Drug: PROAMP, subcutaneous serum physiological saline; Drug: Verapamil

• Registration Number: NCT00804895
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2008-12-08
• Study First Posted: 2008-12-09
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-23
• Last Update Posted: 2012-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Verapamil	PROAMP, subcutaneous serum physiological saline
1	ALTIM, cortivazol injections	subcutaneous injection of Cortivazol ALTIM, 3,375mg
1	Verapamil	subcutaneous injection of Cortivazol ALTIM, 3,375mg
2	PROAMP, subcutaneous serum physiological saline	PROAMP, subcutaneous serum physiological saline

Primary Outcome Measures

Name	Time	Method
Number of patients with a daily attack frequency equal or inferior to two for the period going from two days after third injection to four days after the third injection	2009

Secondary Outcome Measures

Name	Time	Method
total number of attacks on the J1-J15 period	2009
percentage of patients with a 50% or more decrease in attacks frequency at J15	2009
percentage of patients reaching a remission at J30 defined as an absence of attacks for seven days or more	2009
interval between the first injection and appearance of a remission	2009
percentage of patients suffering from chronic CH, having reached a daily attack frequency equal or inferior to two, presenting a recurrence of attacks after J15, defined as more than two attacks per day	2009
number of patients (episodic or chronic) presenting a daily attack frequency equal or inferior to two at J30	2009
number of chronic patients presenting a daily attack frequency equal or inferior to two at J90	2009
HIT-6 scores, comparison between groups at J0 and J30	2009
tolerance of treatment : percentage of patients showing side effects	2009
safety of treatment: percentage of patients with serious adverse events	2009

Trial Locations

Locations (1)

CHU Lariboisière, AP-HP, Centre des Urgences Céphalées (Emergency Headacha Center); 🇫🇷 Paris, Ile de France, France