Clinical trial NCT00804895: Cluster Headache Cortivazol Injection (CHCI)
Official title: A Double Blind Randomized Controlled Trial of Greater Occipital Nerve Infiltration in Cluster Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cluster Headache
Keywords: cluster headache
greater occipital nerve block
cortivazol
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 2009
Secondary outcomes:
measure: total number of attacks on the J1-J15 period
timeFrame: 2009
measure: percentage of patients with a 50% or more decrease in attacks frequency at J15
timeFrame: 2009
measure: percentage of patients reaching a remission at J30 defined as an absence of attacks for seven days or more
timeFrame: 2009
measure: interval between the first injection and appearance of a remission
timeFrame: 2009
measure: 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
timeFrame: 2009
measure: number of patients (episodic or chronic) presenting a daily attack frequency equal or inferior to two at J30
timeFrame: 2009
measure: number of chronic patients presenting a daily attack frequency equal or inferior to two at J90
timeFrame: 2009
measure: HIT-6 scores, comparison between groups at J0 and J30
timeFrame: 2009
measure: tolerance of treatment : percentage of patients showing side effects
timeFrame: 2009
measure: safety of treatment: percentage of patients with serious adverse events
timeFrame: 2009
Other outcomes:
Locations:
city: Paris
country: France
facility: CHU Lariboisière, AP-HP, Centre des Urgences Céphalées (Emergency Headacha Center)
state: Ile de France
Study officials:
affiliation: CHU Lariboisière, AP-HP
name: Dominique VALADE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.