Cluster Headache Cortivazol Injection (CHCI)

Condition(s) targeted: Cluster Headache

Intervention: ALTIM, cortivazol injections in greater occipital nerve injection (Drug); PROAMP, subcutaneous serum physiological saline (Drug); Verapamil (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Dominique VALADE, MD, Principal Investigator, Affiliation: CHU Lariboisière, AP-HP

Overall contact:
Dominique VALADE, MD, Phone: +33(0) 1 49 95 65 37, Email: dominique.valade@lrb.aphp.fr

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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

Secondary outcome:

total number of attacks on the J1-J15 period

percentage of patients with a 50% or more decrease in attacks frequency at J15

percentage of patients reaching a remission at J30 defined as an absence of attacks for seven days or more

interval between the first injection and appearance of a remission

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

number of patients (episodic or chronic) presenting a daily attack frequency equal or inferior to two at J30

number of chronic patients presenting a daily attack frequency equal or inferior to two at J90

HIT-6 scores, comparison between groups at J0 and J30

tolerance of treatment : percentage of patients showing side effects

safety of treatment: percentage of patients with serious adverse events

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Dominique VALADE, MD, Phone: +33(0) 1 49 95 65 37, Email: dominique.valade@lrb.aphp.fr

CHU Lariboisière, AP-HP, Centre des Urgences Céphalées (Emergency Headacha Center), PARIS, Ile de France 75010, France; Recruiting
Dominique VALADE, MD, Phone: +33 1 49 95 65 37, Email: dominique.valade@lrb.aphp.fr
Elizabeth LEROUX, MD FRCPC, Phone: +33 1 49 95 65 37, Email: elileroux@hotmail.com
Dominique VALADE, MD, Principal Investigator
Elizabeth LEROUX, MD, FRCPC, Sub-Investigator

Starting date: December 2008
Ending date: January 2010
Last updated: January 28, 2009