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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | subcutaneous injection of Cortivazol ALTIM, 3,375mg |
|
| 2 | Placebo Comparator | PROAMP, subcutaneous serum physiological saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALTIM, cortivazol injections | Drug | ALTIM, cortivazol in greater occipital nerve injection separated by 2 or 3 days each. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2009 |
| Measure | Description | Time Frame |
|---|---|---|
| total number of attacks on the J1-J15 period | 2009 | |
| percentage of patients with a 50% or more decrease in attacks frequency at J15 | 2009 | |
| percentage of patients reaching a remission at J30 defined as an absence of attacks for seven days or more |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominique VALADE, MD | CHU Lariboisière, AP-HP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Lariboisière, AP-HP, Centre des Urgences Céphalées (Emergency Headacha Center) | Paris | Île-de-France Region | 75010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21903477 | Result | Leroux E, Valade D, Taifas I, Vicaut E, Chagnon M, Roos C, Ducros A. Suboccipital steroid injections for transitional treatment of patients with more than two cluster headache attacks per day: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2011 Oct;10(10):891-7. doi: 10.1016/S1474-4422(11)70186-7. Epub 2011 Sep 6. |
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| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D014700 | Verapamil |
| ID | Term |
|---|---|
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| PROAMP, subcutaneous serum physiological saline | Drug | 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. |
|
| Verapamil | Drug | standard prophylactic treatment |
|
| 2009 |
| interval between the first injection and appearance of a remission | 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 | 2009 |
| number of patients (episodic or chronic) presenting a daily attack frequency equal or inferior to two at J30 | 2009 |
| number of chronic patients presenting a daily attack frequency equal or inferior to two at J90 | 2009 |
| HIT-6 scores, comparison between groups at J0 and J30 | 2009 |
| tolerance of treatment : percentage of patients showing side effects | 2009 |
| safety of treatment: percentage of patients with serious adverse events | 2009 |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |