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
  Purpose

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 Intervention Phase
Cluster Headache
Drug: ALTIM, cortivazol injections
Drug: PROAMP, subcutaneous serum physiological saline
Drug: Verapamil
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind Randomized Controlled Trial of Greater Occipital Nerve Infiltration in Cluster Headache

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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 [ Time Frame: 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 43
Study Start Date: December 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Verapamil
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.
Other Name: PROAMP, subcutaneous serum physiological saline
Drug: Verapamil
standard prophylactic treatment
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804895

Locations
France
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
Investigators
Principal Investigator: Dominique VALADE, MD CHU Lariboisière, AP-HP
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00804895     History of Changes
Other Study ID Numbers: P080602
Study First Received: December 8, 2008
Last Updated: November 23, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
cluster headache
greater occipital nerve block
cortivazol

Additional relevant MeSH terms:
Cluster Headache
Headache
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Verapamil
Cortivazol
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 22, 2014