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Cluster Headache Cortivazol Injection (CHCI)

NCT ID: NCT00804895

Last Updated: 2012-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-10-31

Brief Summary

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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

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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.

Conditions

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Cluster Headache

Keywords

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cluster headache greater occipital nerve block cortivazol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

subcutaneous injection of Cortivazol ALTIM, 3,375mg

Group Type EXPERIMENTAL

ALTIM, cortivazol injections

Intervention Type DRUG

ALTIM, cortivazol in greater occipital nerve injection separated by 2 or 3 days each.

Verapamil

Intervention Type DRUG

standard prophylactic treatment

2

PROAMP, subcutaneous serum physiological saline

Group Type PLACEBO_COMPARATOR

PROAMP, subcutaneous serum physiological saline

Intervention Type DRUG

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.

Verapamil

Intervention Type DRUG

standard prophylactic treatment

Interventions

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ALTIM, cortivazol injections

ALTIM, cortivazol in greater occipital nerve injection separated by 2 or 3 days each.

Intervention Type 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.

Intervention Type DRUG

Verapamil

standard prophylactic treatment

Intervention Type DRUG

Other Intervention Names

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ALTIM, cortivazol injections greater occipital

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dominique VALADE, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Lariboisière, AP-HP

Locations

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

Paris, Île-de-France Region, France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 21903477 (View on PubMed)

Other Identifiers

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P080602

Identifier Type: -

Identifier Source: org_study_id