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Clinical Trials in France / NCT04406259
Active, not recruiting Phase 4

Atrioventricular Block and Cluster Headache (SEVA)

NCT04406259 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire de Nice
Phase
Phase 4
Started
2020-11-02
Last updated
2025-12-02

Condition(s) studied

Cluster Headache

Investigational drug(s) / intervention(s)

Verapamil →

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (2)

FacilityCityRegionStatus
CHU de Nice Nice CHUN
AP-HP Hôpital la Timone Marseille France

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Other trials for the same condition

Efficacy of Light Therapy in Treatment of Chronic Cluster Headache Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04406259 on ClinicalTrials.gov ↗ ← All trials in France