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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00804895 |
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 |
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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 |
Estimated Enrollment: | 60 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
subcutaneous injection of Cortivazol ALTIM, 3,375mg
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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. Injection separated by 2 or 3 days each.
Drug: Verapamil
standard prophylactic treatment
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2: Placebo Comparator
PROAMP, subcutaneous serum physiological saline
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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
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dominique VALADE, MD | +33(0) 1 49 95 65 37 | dominique.valade@lrb.aphp.fr |
Contact: Elizabeth LEROUX, MD FRCPC | +33(0) 1 49 95 65 37 | elileroux@hotmail.com |
France, Ile de France | |
CHU Lariboisière, AP-HP, Centre des Urgences Céphalées (Emergency Headacha Center) | |
PARIS, Ile de France, France, 75010 |
Principal Investigator: | Dominique VALADE, MD | CHU Lariboisière, AP-HP |
Responsible Party: | Department Clinical Research of Developpemnt ( Yannick Vacher ) |
Study ID Numbers: | P080602, EudraCT: 2008-005710-48 |
Study First Received: | December 8, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00804895 |
Health Authority: | France: Ministry of Health |
cluster headache greater occipital nerve block cortivazol |
Cluster Headache Cortivazol Central Nervous System Diseases Headache Disorders, Primary Pain Brain Diseases Headache Disorders |
Signs and Symptoms Calcium, Dietary Verapamil Headache Diltiazem Neurologic Manifestations |
Trigeminal Autonomic Cephalalgias Anti-Inflammatory Agents Membrane Transport Modulators Vasodilator Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Nervous System Diseases Calcium Channel Blockers Cardiovascular Agents Anti-Arrhythmia Agents Antihypertensive Agents Pharmacologic Actions |