A Phase 4 interventional study of Verapamil in Cluster Headache, sponsored by Centre Hospitalier Universitaire de Nice. Active, not recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Centre Hospitalier Universitaire de Nice · Phase 4, Interventional, and Other
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.
123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.
This study's planned enrollment of 60 is above the median of 42 across 90 interventional studies indexed under Cluster Headache.
Browse Cluster Headache studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Time frame: 27 months
Description of the different atrioventricular conduction abnormities and their incidence
Study of ECG results
Time frame: 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
Time frame: 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
Time frame: 27 months
Plan to share: No — No data sharing plan ahs been established
No publications or documents are linked to this record.
Ran from Nov 2020 to primary completion in Sep 2025, 58 months.
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This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Verapamil
Centre Hospitalier Universitaire de Nice →