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Cluster Headache Cortivazol Injection (CHCI) (CHCI)

Primary Purpose

Cluster Headache

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
ALTIM, cortivazol injections
PROAMP, subcutaneous serum physiological saline
Verapamil
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cluster Headache focused on measuring cluster headache, greater occipital nerve block, cortivazol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Lariboisière, AP-HP, Centre des Urgences Céphalées (Emergency Headacha Center)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

subcutaneous injection of Cortivazol ALTIM, 3,375mg

PROAMP, subcutaneous serum physiological saline

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

total number of attacks on the J1-J15 period
percentage of patients with a 50% or more decrease in attacks frequency at J15
percentage of patients reaching a remission at J30 defined as an absence of attacks for seven days or more
interval between the first injection and appearance of a remission
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
number of patients (episodic or chronic) presenting a daily attack frequency equal or inferior to two at J30
number of chronic patients presenting a daily attack frequency equal or inferior to two at J90
HIT-6 scores, comparison between groups at J0 and J30
tolerance of treatment : percentage of patients showing side effects
safety of treatment: percentage of patients with serious adverse events

Full Information

First Posted
December 8, 2008
Last Updated
November 23, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00804895
Brief Title
Cluster Headache Cortivazol Injection (CHCI)
Acronym
CHCI
Official Title
A Double Blind Randomized Controlled Trial of Greater Occipital Nerve Infiltration in Cluster Headache
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cluster Headache
Keywords
cluster headache, greater occipital nerve block, cortivazol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
subcutaneous injection of Cortivazol ALTIM, 3,375mg
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
PROAMP, subcutaneous serum physiological saline
Intervention Type
Drug
Intervention Name(s)
ALTIM, cortivazol injections
Other Intervention Name(s)
ALTIM, cortivazol injections greater occipital
Intervention Description
ALTIM, cortivazol in greater occipital nerve injection separated by 2 or 3 days each.
Intervention Type
Drug
Intervention Name(s)
PROAMP, subcutaneous serum physiological saline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Verapamil
Intervention Description
standard prophylactic treatment
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
total number of attacks on the J1-J15 period
Time Frame
2009
Title
percentage of patients with a 50% or more decrease in attacks frequency at J15
Time Frame
2009
Title
percentage of patients reaching a remission at J30 defined as an absence of attacks for seven days or more
Time Frame
2009
Title
interval between the first injection and appearance of a remission
Time Frame
2009
Title
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
Title
number of patients (episodic or chronic) presenting a daily attack frequency equal or inferior to two at J30
Time Frame
2009
Title
number of chronic patients presenting a daily attack frequency equal or inferior to two at J90
Time Frame
2009
Title
HIT-6 scores, comparison between groups at J0 and J30
Time Frame
2009
Title
tolerance of treatment : percentage of patients showing side effects
Time Frame
2009
Title
safety of treatment: percentage of patients with serious adverse events
Time Frame
2009

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique VALADE, MD
Organizational Affiliation
CHU Lariboisière, AP-HP
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Lariboisière, AP-HP, Centre des Urgences Céphalées (Emergency Headacha Center)
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75010
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21903477
Citation
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.
Results Reference
result

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Cluster Headache Cortivazol Injection (CHCI)

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