Cluster Headache Cortivazol Injection (CHCI) - Full Text View

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00804895

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 in greater occipital nerve injection Drug: PROAMP, subcutaneous serum physiological saline Drug: Verapamil	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double Blind Randomized Controlled Trial of Greater Occipital Nerve Infiltration in Cluster Headache

Resource links provided by NLM:

MedlinePlus related topics: Headache

Drug Information available for: Verapamil Diltiazem hydrochloride Dexverapamil Diltiazem Diltiazem malate Verapamil hydrochloride Cortivazol

U.S. FDA Resources

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:	60
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
1: Experimental subcutaneous injection of Cortivazol ALTIM, 3,375mg	Drug: ALTIM, cortivazol injections in greater occipital nerve injection 3 injections will be performed at the level of the greater occipital nerve with a suboccipital approach. Drug: Verapamil standard prophylactic treatment
2: Placebo Comparator 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

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

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

Locations

France, Ile de 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

No publications provided

Responsible Party:	Department Clinical Research of Developpemnt ( Yannick Vacher )
Study ID Numbers:	P080602
Study First Received:	December 8, 2008
Last Updated:	November 30, 2009
ClinicalTrials.gov Identifier:	NCT00804895 History of Changes
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:

Anti-Inflammatory Agents
Cluster Headache
Cortivazol
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Calcium Channel Blockers
Central Nervous System Diseases
Headache Disorders, Primary
Pain
Cardiovascular Agents
Antihypertensive Agents

Brain Diseases
Pharmacologic Actions
Headache Disorders
Membrane Transport Modulators
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Verapamil
Therapeutic Uses
Headache
Diltiazem
Neurologic Manifestations
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on February 08, 2010