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Atrioventricular Block and Cluster Headache (SEVA)

C

Centre Hospitalier Universitaire de Nice

Status and phase

Active, not recruiting
Phase 4

Conditions

Cluster Headache

Treatments

Drug: Verapamil

Study type

Interventional

Funder types

Other

Identifiers

NCT04406259
18-API-03

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Verapamil
Other group
Description:
administration of verapamil to treat cluster headache
Treatment:
Drug: Verapamil

Trial contacts and locations

2

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Central trial contact

Maeva GODEMERT; Elise VAN OBBERGHEN

Data sourced from clinicaltrials.gov

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