Atrioventricular Block and Cluster Headache (SEVA)

NCT ID: NCT04406259

Last Updated: 2025-12-02

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2027-09-05

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.

Detailed Description

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Conditions

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Cluster Headache

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective cohort, interventional , multicentric study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Verapamil

administration of verapamil to treat cluster headache

Group Type OTHER

Verapamil

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Nice

Nice, CHUN, France

Site Status

AP-HP Hôpital la Timone

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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18-API-03

Identifier Type: -

Identifier Source: org_study_id

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