Atrioventricular Block and Cluster Headache (SEVA)

Cluster Headache Clinical Trial

— SEVA  

Official title:

Atrioventricular Block and Cluster Headache

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04406259
• Other study ID #: 18-API-03
• Status: Recruiting
• Phase: Phase 4
• Start date: November 2, 2020
• Est. completion date: March 1, 2025

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Elise VAN OBBERGHEN
• Phone: +33 4 92 03 75 53
• Email: vanobberghen.e[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrioventricular Block
• Cluster Headache
• Headache

Intervention

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.

Locations

Country	Name	City	State
France	AP-HP Hôpital la Timone	Marseille
France	CHU de Nice	NICE Cedex 1	Chun

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Description of the different atrioventricular conduction abnormities and their incidence	Study of ECG results	27 months
Secondary	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
Secondary	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