Clinical Trial: Cluster Headache Cortivazol Injection (CHCI)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Assistance Publique - Hôpitaux de Paris

Current 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 [ Time Frame: 2009 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: December 8, 2008
Date Started: December 2008
Date Completion:
Last Updated: November 23, 2012
Last Verified: November 2012