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Atrioventricular Block and Cluster Headache (SEVA) (SEVA)

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ClinicalTrials.gov Identifier: NCT04406259
Recruitment Status : Not yet recruiting
First Posted : May 28, 2020
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cluster Headache Drug: Verapamil Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: prospective cohort, interventional , multicentric study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Atrioventricular Block and Cluster Headache
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arms and Interventions
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Arm Intervention/treatment
Verapamil
administration of verapamil to treat cluster headache
 Drug: Verapamil

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.


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of the atrioventricular block when verapamil is used in prevention of Cluster Headache. [ Time Frame: 27 months ]
    Occurrence of the ratio of patients presenting a first degree atrioventricular block


Secondary Outcome Measures :
  1. Description of the different atrioventricular conduction abnormities and their incidence [ Time Frame: 27 months ]
    Study of ECG results

  2. Evaluation of the plasmatic concentration of verapamil and its metabolite (nor verapamil) in parallel with the occurrence of conduction abnormalities detected by electrocardiogram [ Time Frame: 27 months ]
    Plasmatic concentration of verapamil and its metabolite (nor verapamil) dosed at each visit

  3. Relation between pharmacokinetic/ pharmacodynamics of verapamil and the appearance of conduction abnormalities to determinate the maximal tolerated dose of verapamil. [ Time Frame: 27 months ]
    The maximal tolerated dose of verapamil will be determined thanks to correlation between ECG results and Pharmacocinetics and pharmacodynamics


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406259


Contacts
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Contact: Elise VAN OBBERGHEN +33 4 92 03 75 53 vanobberghen.e@chu-nice.fr
Contact: Maeva GODEMERT godemert@chu-nice.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT04406259    
Other Study ID Numbers: 18-API-03
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data sharing plan ahs been established

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cluster Headache
Atrioventricular Block
Headache
Pain
Neurologic Manifestations
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Heart Block
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Verapamil
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents