Atrioventricular Block and Cluster Headache (SEVA)

Phase 4

Recruiting

• Conditions: Cluster Headache
• Interventions: Drug: Verapamil

• Registration Number: NCT04406259
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-22
• Study First Posted: 2020-05-28
• Study Start: 2020-11-02
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-25
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Verapamil	Verapamil	administration of verapamil to treat cluster headache

Primary Outcome Measures

Name	Time	Method
Evaluation of the atrioventricular block when verapamil is used in prevention of Cluster Headache.	27 months	Occurrence of the ratio of patients presenting a first degree atrioventricular block

Secondary Outcome Measures

Name	Time	Method
Description of the different atrioventricular conduction abnormities and their incidence	27 months	Study of ECG results
Relation between pharmacokinetic/ pharmacodynamics of verapamil and the appearance of conduction abnormalities to determinate the maximal tolerated dose of verapamil.	27 months	The maximal tolerated dose of verapamil will be determined thanks to correlation between ECG results and Pharmacocinetics and pharmacodynamics
Evaluation of the plasmatic concentration of verapamil and its metabolite (nor verapamil) in parallel with the occurrence of conduction abnormalities detected by electrocardiogram	27 months	Plasmatic concentration of verapamil and its metabolite (nor verapamil) dosed at each visit

Trial Locations

Locations (2)

AP-HP Hôpital la Timone; 🇫🇷 Marseille, France

CHU de Nice; 🇫🇷 NICE Cedex 1, Chun, France