A Phase 2/3 interventional study of ALTIM, cortivazol injections and PROAMP, subcutaneous serum physiological saline in Cluster Headache, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-11-27.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2/3, Interventional, and Treatment
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.
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.
116 studies on the registry are indexed under Cluster Headache; 27 are open to participants now.
This study's enrollment of 43 is close to the median of 42 across 86 interventional studies indexed under Cluster Headache.
Browse Cluster Headache studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
subcutaneous injection of Cortivazol ALTIM, 3,375mg
Drug: ALTIM, cortivazol injections · Drug: Verapamil
PROAMP, subcutaneous serum physiological saline
Drug: PROAMP, subcutaneous serum physiological saline · Drug: Verapamil
ALTIM, cortivazol in greater occipital nerve injection separated by 2 or 3 days each.
Also known as: ALTIM, cortivazol injections greater occipital
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.
standard prophylactic treatment
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
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
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris