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Active, Not Recruiting

NCT Number: NCT04406259

Atrioventricular Block and Cluster Headache (SEVA)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Nice, Nice, CHUN, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 27 months

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

Secondary outcomes

  1. Description of the different atrioventricular conduction abnormities and their incidence

    Time frame: 27 months

    Study of ECG results

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

    Time frame: 27 months

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

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

    Time frame: 27 months

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Atrioventricular Block and Cluster Headache

Acronym: SEVA

Important dates

Study start
2020
Primary completion
2025
Study completion
2027
First posted
May 28, 2020
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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