Cluster Headache Cortivazol Injection (CHCI)

Cluster Headache Clinical Trial

— CHCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804895
• Other study ID #: P080602
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 8, 2008
• Last updated: November 23, 2012
• Start date: December 2008
• Est. completion date: October 2009

Study information

• Verified date: November 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cluster Headache
• Headache

Intervention

Drug:
• ALTIM, cortivazol injections
ALTIM, cortivazol in greater occipital nerve injection separated by 2 or 3 days each.
• 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.
• Verapamil
standard prophylactic treatment

Locations

Country	Name	City	State
France	CHU Lariboisière, AP-HP, Centre des Urgences Céphalées (Emergency Headacha Center)	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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 N — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	total number of attacks on the J1-J15 period		2009	No
Secondary	percentage of patients with a 50% or more decrease in attacks frequency at J15		2009	No
Secondary	percentage of patients reaching a remission at J30 defined as an absence of attacks for seven days or more		2009	No
Secondary	interval between the first injection and appearance of a remission		2009	No
Secondary	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	No
Secondary	number of patients (episodic or chronic) presenting a daily attack frequency equal or inferior to two at J30		2009	No
Secondary	number of chronic patients presenting a daily attack frequency equal or inferior to two at J90		2009	No
Secondary	HIT-6 scores, comparison between groups at J0 and J30		2009	No
Secondary	tolerance of treatment : percentage of patients showing side effects		2009	Yes
Secondary	safety of treatment: percentage of patients with serious adverse events		2009	Yes