Atrioventricular Block and Cluster Headache (SEVA) (SEVA)

Atrioventricular Block and Cluster Headache

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.

Study Overview

• Status: Recruiting
• Conditions: Cluster Headache
• Intervention / Treatment: Drug: Verapamil

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Elise VAN OBBERGHEN; Phone Number: +33 4 92 03 75 53; Email: vanobberghen.e@chu-nice.fr
• Study Contact Backup: Name: Maeva GODEMERT; Email: godemert@chu-nice.fr

Study Locations

• France
  • Marseille, France, 13005
    • Recruiting
    • AP-HP Hôpital la Timone
    • Contact: Anne DONNET
    • Contact: Imane INAL; Email: imane.inal@ap-hm.fr
  • Chun
    • NICE Cedex 1, Chun, France, 06003
      • Recruiting
      • Chu de Nice
      • Contact: Elise VAN OBBERGHEN; Phone Number: +33492037553; Email: van-obberghen-blanc.e@chu-nice.fr
      • Contact: Sylvie ROMETTINO; Email: romettino.s@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Verapamil; administration of verapamil to treat cluster headache	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the different atrioventricular conduction abnormities and their incidence	Study of ECG results	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	Plasmatic concentration of verapamil and its metabolite (nor verapamil) dosed at each visit	27 months
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Headache Disorders, Primary; Headache Disorders; Heart Block; Trigeminal Autonomic Cephalalgias; Headache; Cluster Headache; Atrioventricular Block; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Verapamil
• Other Study ID Numbers: 18-API-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No data sharing plan ahs been established

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No