Cluster Headache Cortivazol Injection (CHCI)

Last updated: November 23, 2012
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Completed

Phase

2/3

Condition

Pain

Migraine (Pediatric)

Oral Facial Pain

Treatment

N/A

Clinical Study ID

NCT00804895
P080602
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofInternational Headache Society (ICHD-II)

  • patient with more than two episodes of CH per day

  • patient with a normal medical examination

Exclusion

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 attacksfrom 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

Total Participants: 43
Study Start date:
December 01, 2008
Estimated Completion Date:
October 31, 2009

Study 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.

Connect with a study center

  • CHU Lariboisière, AP-HP, Centre des Urgences Céphalées (Emergency Headacha Center)

    Paris, Ile de France 75010
    France

    Site Not Available

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