Atrioventricular Block and Cluster Headache (SEVA) (SEVA)
Primary Purpose
Cluster Headache
Status
Recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Verapamil
Sponsored by
About this trial
This is an interventional other trial for Cluster Headache
Eligibility Criteria
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
Sites / Locations
- CHU de NiceRecruiting
- AP-HP Hôpital la TimoneRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Verapamil
Arm Description
administration of verapamil to treat cluster headache
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Description of the different atrioventricular conduction abnormities and their incidence
Study of ECG results
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
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
Full Information
NCT ID
NCT04406259
First Posted
May 14, 2020
Last Updated
January 23, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04406259
Brief Title
Atrioventricular Block and Cluster Headache (SEVA)
Acronym
SEVA
Official Title
Atrioventricular Block and Cluster Headache
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cluster Headache
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
prospective cohort, interventional , multicentric study
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Verapamil
Arm Type
Other
Arm Description
administration of verapamil to treat cluster headache
Intervention Type
Drug
Intervention Name(s)
Verapamil
Intervention Description
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 Outcome Measure Information:
Title
Evaluation of the atrioventricular block when verapamil is used in prevention of Cluster Headache.
Description
Occurrence of the ratio of patients presenting a first degree atrioventricular block
Time Frame
27 months
Secondary Outcome Measure Information:
Title
Description of the different atrioventricular conduction abnormities and their incidence
Description
Study of ECG results
Time Frame
27 months
Title
Evaluation of the plasmatic concentration of verapamil and its metabolite (nor verapamil) in parallel with the occurrence of conduction abnormalities detected by electrocardiogram
Description
Plasmatic concentration of verapamil and its metabolite (nor verapamil) dosed at each visit
Time Frame
27 months
Title
Relation between pharmacokinetic/ pharmacodynamics of verapamil and the appearance of conduction abnormalities to determinate the maximal tolerated dose of verapamil.
Description
The maximal tolerated dose of verapamil will be determined thanks to correlation between ECG results and Pharmacocinetics and pharmacodynamics
Time Frame
27 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elise VAN OBBERGHEN
Phone
+33 4 92 03 75 53
Email
vanobberghen.e@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Maeva GODEMERT
Email
godemert@chu-nice.fr
Facility Information:
Facility Name
CHU de Nice
City
NICE Cedex 1
State/Province
Chun
ZIP/Postal Code
06003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise VAN OBBERGHEN
Phone
+33492037553
Email
van-obberghen-blanc.e@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Sylvie ROMETTINO
Email
romettino.s@chu-nice.fr
Facility Name
AP-HP Hôpital la Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne DONNET
First Name & Middle Initial & Last Name & Degree
Imane INAL
Email
imane.inal@ap-hm.fr
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No data sharing plan ahs been established
Learn more about this trial
Atrioventricular Block and Cluster Headache (SEVA)
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