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Verapamil is a calcium channel blocker widely used to treat cardiovascular diseases however it is also the first line treatment in the prevention of cluster headaches. In France, its prescription in that indication is based on compliance with the Temporary Recommendation for Use (RTU) that insists on the possible the cardiac side effects that can occur as the doses required for cluster headache are significantly higher than the doses used in cardiology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verapamil | Other | administration of verapamil to treat cluster headache |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verapamil | Drug | Patients in groupe A require verapamil initiation as a preventive treatment and patients in group B are patients already undergoing a verapamil treatment for their Cluster Headache. The doses of verapamil are increased for the patients in group A, after a clinical examination an electrocardiogram, and a blood test. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the atrioventricular block when verapamil is used in prevention of Cluster Headache. | Occurrence of the ratio of patients presenting a first degree atrioventricular block | 27 months |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the different atrioventricular conduction abnormities and their incidence | Study of ECG results | 27 months |
| Evaluation of the plasmatic concentration of verapamil and its metabolite (nor verapamil) in parallel with the occurrence of conduction abnormalities detected by electrocardiogram |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nice | Nice | CHUN | 06003 | France | ||
| AP-HP Hôpital la Timone |
No data sharing plan ahs been established
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| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D014700 | Verapamil |
| ID | Term |
|---|---|
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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prospective cohort, interventional , multicentric study
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|
Plasmatic concentration of verapamil and its metabolite (nor verapamil) dosed at each visit |
| 27 months |
| Relation between pharmacokinetic/ pharmacodynamics of verapamil and the appearance of conduction abnormalities to determinate the maximal tolerated dose of verapamil. | The maximal tolerated dose of verapamil will be determined thanks to correlation between ECG results and Pharmacocinetics and pharmacodynamics | 27 months |
| Marseille |
| 13005 |
| France |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |