Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04406259
Other study ID # 18-API-03
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 2, 2020
Est. completion date March 1, 2025

Study information

Verified date January 2023
Source Centre Hospitalier Universitaire de Nice
Contact Elise VAN OBBERGHEN
Phone +33 4 92 03 75 53
Email vanobberghen.e@chu-nice.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France AP-HP Hôpital la Timone Marseille
France CHU de Nice NICE Cedex 1 Chun

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 27 months
Secondary Description of the different atrioventricular conduction abnormities and their incidence Study of ECG results 27 months
Secondary 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 27 months
Secondary 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 27 months
See also
  Status Clinical Trial Phase
Recruiting NCT05264714 - Cluster Headache Treatment With Rimegepant Phase 2
Completed NCT01677026 - Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache
Terminated NCT00203190 - A Double-Blind, Placebo-Controlled Study Examining the Use of Topiramate in the Treatment of Cluster Headache Phase 4
Terminated NCT04570475 - High Dose Vitamin D Plus Multivitamin in the Prevention of Cluster Headache Phase 3
Completed NCT04066023 - Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches Phase 2/Phase 3
Withdrawn NCT04353505 - Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache Phase 1
Completed NCT02019017 - Botox Injection in Treatment of Cluster Headache Phase 1/Phase 2
Completed NCT05153876 - An Open Internet-based Survey and Natural Language Processing Project Analysing Written Monologues by Headache Patients
Recruiting NCT05324748 - Repeated GON Injections in CCH Phase 3
Completed NCT02782533 - DBS of the Third Ventricle for Cluster Headache and Obesity N/A
Completed NCT04179266 - Effect of Ketamine Intranasal Spray in Treatment of Chronic Cluster Headache Phase 1/Phase 2
Recruiting NCT06206772 - Resting State Functional Connectivity in Cluster Headache
Recruiting NCT03944876 - Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Cluster Headache Phase 3
Not yet recruiting NCT05857098 - Detection of Local Field Potentials in the Ventral Tegmental Area of the Midbrain in Chronic Cluster Headache Patients
Recruiting NCT02910323 - The Will Erwin Headache Research Center - Cluster Headache Study
Terminated NCT00458770 - Study of Hypothalamic Metabolism in Spontaneous Cluster Headache Attacks N/A
Completed NCT00662935 - Evaluation of Efficacity and Safety of Deep Brain Stimulation (DBS) in Chronic and Treatment-Resistant Cluster Headache(CH) N/A
Active, not recruiting NCT03511846 - Pain Biomarker Study Phase 1
Completed NCT00184587 - Prophylactic Treatment of Episodic Cluster Headache Phase 2
Not yet recruiting NCT06277063 - nVNS for the Prevention and Treatment of Primary Headache N/A