Atrioventricular Block and Cluster Headache (SEVA)

NCT04406259 | Active Not Recruiting Phase 4

• 1 other identifier: 18-API-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Cluster Headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Description of the different atrioventricular conduction abnormities and their incidence

  27 months

• 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

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

  27 months

Study Arms (1)

Verapamil

OTHER

administration of verapamil to treat cluster headache

Drug: Verapamil

Interventions

Verapamil 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.

Verapamil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (2)

CHU de Nice

Nice, CHUN, 06003, France

Location

AP-HP Hôpital la Timone

Marseille, 13005, France

Location

MeSH Terms

Conditions

Cluster Headache

Interventions

Verapamil

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective cohort, interventional , multicentric study

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 28, 2020
• Study Start: November 2, 2020
• Primary Completion: September 5, 2025
• Study Completion (Estimated): September 5, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)