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Cluster Headache Cortivazol Injection (CHCI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00804895
First received: December 8, 2008
Last updated: November 23, 2012
Last verified: November 2012

December 8, 2008
November 23, 2012
December 2008
October 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00804895 on ClinicalTrials.gov Archive Site
  • total number of attacks on the J1-J15 period [ Time Frame: 2009 ] [ Designated as safety issue: No ]
  • percentage of patients with a 50% or more decrease in attacks frequency at J15 [ Time Frame: 2009 ] [ Designated as safety issue: No ]
  • percentage of patients reaching a remission at J30 defined as an absence of attacks for seven days or more [ Time Frame: 2009 ] [ Designated as safety issue: No ]
  • interval between the first injection and appearance of a remission [ Time Frame: 2009 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • number of patients (episodic or chronic) presenting a daily attack frequency equal or inferior to two at J30 [ Time Frame: 2009 ] [ Designated as safety issue: No ]
  • number of chronic patients presenting a daily attack frequency equal or inferior to two at J90 [ Time Frame: 2009 ] [ Designated as safety issue: No ]
  • HIT-6 scores, comparison between groups at J0 and J30 [ Time Frame: 2009 ] [ Designated as safety issue: No ]
  • tolerance of treatment : percentage of patients showing side effects [ Time Frame: 2009 ] [ Designated as safety issue: Yes ]
  • safety of treatment: percentage of patients with serious adverse events [ Time Frame: 2009 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Cluster Headache Cortivazol Injection (CHCI)
A Double Blind Randomized Controlled Trial of Greater Occipital Nerve Infiltration in Cluster Headache

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Cluster Headache
  • 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: 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.
    Other Name: PROAMP, subcutaneous serum physiological saline
  • Drug: Verapamil
    standard prophylactic treatment
    Other Name: Verapamil
  • Experimental: 1
    subcutaneous injection of Cortivazol ALTIM, 3,375mg
    Interventions:
    • Drug: ALTIM, cortivazol injections
    • Drug: Verapamil
  • Placebo Comparator: 2
    PROAMP, subcutaneous serum physiological saline
    Interventions:
    • Drug: PROAMP, subcutaneous serum physiological saline
    • Drug: Verapamil
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00804895
P080602
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Dominique VALADE, MD CHU Lariboisière, AP-HP
Assistance Publique - Hôpitaux de Paris
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP