Atrioventricular Block and Cluster Headache (SEVA)

Study Overview
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Brief Summary
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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.

Official Title
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Atrioventricular Block and Cluster Headache

Conditions
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Cluster Headache

Intervention / Treatment
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* Drug: Verapamil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient 18 years old, and older patient suffering from Cluster Headache (according to the l'ICHD-3 diagnostic criterias) patients affiliated to the social security patient that has given his full written consent to participate in the study female patients participating in the study must be using an efficient contraception for more than 1 month prior to the beginning of the study Exclusion Criteria: patient presenting contraindications to the use of verapamil patient observing a treatment with ivabradine (Procoralan®), bétablockers, colchicine, l'esmolol, triazolam, quinidine. patient under justicial protection patient breastfeeding, or pregnant patient suffering from a neuromuscular transmisson disease patient with a pacemaker

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: prospective cohort, interventional , multicentric study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Verapamil<br>administration of verapamil to treat cluster headache | Drug: Verapamil<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |