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Cluster Headache Cortivazol Injection (CHCI) (CHCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00804895
Recruitment Status : Completed
First Posted : December 9, 2008
Last Update Posted : November 27, 2012
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Cluster Headache Drug: ALTIM, cortivazol injections Drug: PROAMP, subcutaneous serum physiological saline Drug: Verapamil Phase 2 Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind Randomized Controlled Trial of Greater Occipital Nerve Infiltration in Cluster Headache
Study Start Date : December 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: 1
subcutaneous injection of Cortivazol ALTIM, 3,375mg
Drug: ALTIM, cortivazol injections
ALTIM, cortivazol in greater occipital nerve injection separated by 2 or 3 days each.
Other Name: ALTIM, cortivazol injections greater occipital

Drug: Verapamil
standard prophylactic treatment

Placebo Comparator: 2
PROAMP, subcutaneous serum physiological saline
Drug: PROAMP, subcutaneous serum physiological saline
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.

Drug: Verapamil
standard prophylactic treatment

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. total number of attacks on the J1-J15 period [ Time Frame: 2009 ]
  2. percentage of patients with a 50% or more decrease in attacks frequency at J15 [ Time Frame: 2009 ]
  3. percentage of patients reaching a remission at J30 defined as an absence of attacks for seven days or more [ Time Frame: 2009 ]
  4. interval between the first injection and appearance of a remission [ Time Frame: 2009 ]
  5. 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 ]
  6. number of patients (episodic or chronic) presenting a daily attack frequency equal or inferior to two at J30 [ Time Frame: 2009 ]
  7. number of chronic patients presenting a daily attack frequency equal or inferior to two at J90 [ Time Frame: 2009 ]
  8. HIT-6 scores, comparison between groups at J0 and J30 [ Time Frame: 2009 ]
  9. tolerance of treatment : percentage of patients showing side effects [ Time Frame: 2009 ]
  10. safety of treatment: percentage of patients with serious adverse events [ Time Frame: 2009 ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 of International Headache Society (ICHD-II)
  • patient with more than two episodes of CH per day
  • patient with a normal medical examination

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 attacks from 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00804895

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CHU Lariboisière, AP-HP, Centre des Urgences Céphalées (Emergency Headacha Center)
Paris, Ile de France, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Dominique VALADE, MD CHU Lariboisière, AP-HP
Publications of Results:
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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00804895    
Other Study ID Numbers: P080602
First Posted: December 9, 2008    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: November 2012
Keywords provided by Assistance Publique - Hôpitaux de Paris:
cluster headache
greater occipital nerve block
Additional relevant MeSH terms:
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Cluster Headache
Neurologic Manifestations
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anti-Inflammatory Agents