CHU Lariboisière, AP-HP, Centre des Urgences Céphalées (Emergency Headacha Center)
Paris, Île-de-France Region, 75010, France
NCT Number: NCT00804895
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2 / Phase 3
Paris, Île-de-France Region, 75010, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ALTIM, cortivazol in greater occipital nerve injection separated by 2 or 3 days each.
Other names: 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
Time frame: 2009
Time frame: 2009
Time frame: 2009
Time frame: 2009
Time frame: 2009
Time frame: 2009
Time frame: 2009
Time frame: 2009
Time frame: 2009
Time frame: 2009
Time frame: 2009
Assistance Publique - Hôpitaux de Paris
Other
A Double Blind Randomized Controlled Trial of Greater Occipital Nerve Infiltration in Cluster Headache
Acronym: CHCI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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