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Atrioventricular Block and Cluster Headache (SEVA) (SEVA)

Primary Purpose

Cluster Headache

Status

Recruiting

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Verapamil

About this trial

This is an interventional other trial for Cluster Headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU de NiceRecruiting
AP-HP Hôpital la TimoneRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Verapamil

Arm Description

administration of verapamil to treat cluster headache

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Description of the different atrioventricular conduction abnormities and their incidence

Study of ECG results

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

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

Full Information

NCT ID

NCT04406259

First Posted

May 14, 2020

Last Updated

January 23, 2023

Sponsor

Centre Hospitalier Universitaire de Nice

1. Study Identification

Unique Protocol Identification Number

NCT04406259

Brief Title

Atrioventricular Block and Cluster Headache (SEVA)

Acronym

SEVA

Official Title

Atrioventricular Block and Cluster Headache

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 2, 2020 (Actual)

Primary Completion Date

March 1, 2025 (Anticipated)

Study Completion Date

March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cluster Headache

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

prospective cohort, interventional , multicentric study

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Verapamil

Arm Type

Other

Arm Description

administration of verapamil to treat cluster headache

Intervention Type

Drug

Intervention Name(s)

Verapamil

Intervention Description

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.

Primary Outcome Measure Information:

Title

Evaluation of the atrioventricular block when verapamil is used in prevention of Cluster Headache.

Description

Occurrence of the ratio of patients presenting a first degree atrioventricular block

Time Frame

27 months

Secondary Outcome Measure Information:

Title

Description of the different atrioventricular conduction abnormities and their incidence

Description

Study of ECG results

Time Frame

27 months

Title

Evaluation of the plasmatic concentration of verapamil and its metabolite (nor verapamil) in parallel with the occurrence of conduction abnormalities detected by electrocardiogram

Description

Plasmatic concentration of verapamil and its metabolite (nor verapamil) dosed at each visit

Time Frame

27 months

Title

Relation between pharmacokinetic/ pharmacodynamics of verapamil and the appearance of conduction abnormalities to determinate the maximal tolerated dose of verapamil.

Description

The maximal tolerated dose of verapamil will be determined thanks to correlation between ECG results and Pharmacocinetics and pharmacodynamics

Time Frame

27 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elise VAN OBBERGHEN

Phone

+33 4 92 03 75 53

vanobberghen.e@chu-nice.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Maeva GODEMERT

godemert@chu-nice.fr

Facility Information:

Facility Name

CHU de Nice

City

NICE Cedex 1

State/Province

Chun

ZIP/Postal Code

06003

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elise VAN OBBERGHEN

Phone

+33492037553

van-obberghen-blanc.e@chu-nice.fr

First Name & Middle Initial & Last Name & Degree

Sylvie ROMETTINO

romettino.s@chu-nice.fr

Facility Name

AP-HP Hôpital la Timone

City

Marseille

ZIP/Postal Code

13005

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne DONNET

First Name & Middle Initial & Last Name & Degree

Imane INAL

imane.inal@ap-hm.fr

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No data sharing plan ahs been established

Learn more about this trial

Atrioventricular Block and Cluster Headache (SEVA)

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