<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04406259</url>
  </required_header>
  <id_info>
    <org_study_id>18-API-03</org_study_id>
    <nct_id>NCT04406259</nct_id>
  </id_info>
  <brief_title>Atrioventricular Block and Cluster Headache (SEVA)</brief_title>
  <acronym>SEVA</acronym>
  <official_title>Atrioventricular Block and Cluster Headache</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Verapamil is a calcium channel blocker widely used to treat cardiovascular diseases however&#xD;
      it is also the first line treatment in the prevention of cluster headaches. In France, its&#xD;
      prescription in that indication is based on compliance with the Temporary Recommendation for&#xD;
      Use (RTU) that insists on the possible the cardiac side effects that can occur as the doses&#xD;
      required for cluster headache are significantly higher than the doses used in cardiology.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 2, 2020</start_date>
  <completion_date type="Anticipated">March 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2025</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>prospective cohort, interventional , multicentric study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the atrioventricular block when verapamil is used in prevention of Cluster Headache.</measure>
    <time_frame>27 months</time_frame>
    <description>Occurrence of the ratio of patients presenting a first degree atrioventricular block</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Description of the different atrioventricular conduction abnormities and their incidence</measure>
    <time_frame>27 months</time_frame>
    <description>Study of ECG results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the plasmatic concentration of verapamil and its metabolite (nor verapamil) in parallel with the occurrence of conduction abnormalities detected by electrocardiogram</measure>
    <time_frame>27 months</time_frame>
    <description>Plasmatic concentration of verapamil and its metabolite (nor verapamil) dosed at each visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation between pharmacokinetic/ pharmacodynamics of verapamil and the appearance of conduction abnormalities to determinate the maximal tolerated dose of verapamil.</measure>
    <time_frame>27 months</time_frame>
    <description>The maximal tolerated dose of verapamil will be determined thanks to correlation between ECG results and Pharmacocinetics and pharmacodynamics</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cluster Headache</condition>
  <arm_group>
    <arm_group_label>Verapamil</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>administration of verapamil to treat cluster headache</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Verapamil</intervention_name>
    <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.&#xD;
The doses of verapamil are increased for the patients in group A, after a clinical examination an electrocardiogram, and a blood test.</description>
    <arm_group_label>Verapamil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient 18 years old, and older&#xD;
&#xD;
          -  patient suffering from Cluster Headache (according to the l'ICHD-3 diagnostic&#xD;
             criterias)&#xD;
&#xD;
          -  patients affiliated to the social security&#xD;
&#xD;
          -  patient that has given his full written consent to participate in the study&#xD;
&#xD;
          -  female patients participating in the study must be using an efficient contraception&#xD;
             for more than 1 month prior to the beginning of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient presenting contraindications to the use of verapamil&#xD;
&#xD;
          -  patient observing a treatment with ivabradine (Procoralan®), bétablockers, colchicine,&#xD;
             l'esmolol, triazolam, quinidine.&#xD;
&#xD;
          -  patient under justicial protection&#xD;
&#xD;
          -  patient breastfeeding, or pregnant&#xD;
&#xD;
          -  patient suffering from a neuromuscular transmisson disease&#xD;
&#xD;
          -  patient with a pacemaker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Elise VAN OBBERGHEN</last_name>
    <phone>+33 4 92 03 75 53</phone>
    <email>vanobberghen.e@chu-nice.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maeva GODEMERT</last_name>
    <email>godemert@chu-nice.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU de Nice</name>
      <address>
        <city>NICE Cedex 1</city>
        <state>Chun</state>
        <zip>06003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elise VAN OBBERGHEN</last_name>
      <phone>+33492037553</phone>
      <email>van-obberghen-blanc.e@chu-nice.fr</email>
    </contact>
    <contact_backup>
      <last_name>Sylvie ROMETTINO</last_name>
      <email>romettino.s@chu-nice.fr</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>AP-HP Hôpital la Timone</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne DONNET</last_name>
    </contact>
    <contact_backup>
      <last_name>Imane INAL</last_name>
      <email>imane.inal@ap-hm.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>January 23, 2023</last_update_submitted>
  <last_update_submitted_qc>January 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cluster Headache</mesh_term>
    <mesh_term>Atrioventricular Block</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Verapamil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No data sharing plan ahs been established</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04406259
org study id: 18-API-03
nct id: NCT04406259
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: prospective cohort, interventional , multicentric study
primary purpose: Other
masking: None (Open Label)
measure: Evaluation of the atrioventricular block when verapamil is used in prevention of Cluster Headache.
time frame: 27 months
description: Occurrence of the ratio of patients presenting a first degree atrioventricular block
measure: Description of the different atrioventricular conduction abnormities and their incidence
time frame: 27 months
description: Study of ECG results
measure: Evaluation of the plasmatic concentration of verapamil and its metabolite (nor verapamil) in parallel with the occurrence of conduction abnormalities detected by electrocardiogram
time frame: 27 months
description: Plasmatic concentration of verapamil and its metabolite (nor verapamil) dosed at each visit
measure: Relation between pharmacokinetic/ pharmacodynamics of verapamil and the appearance of conduction abnormalities to determinate the maximal tolerated dose of verapamil.
time frame: 27 months
description: The maximal tolerated dose of verapamil will be determined thanks to correlation between ECG results and Pharmacocinetics and pharmacodynamics
arm group label: Verapamil
arm group type: Other
description: administration of verapamil to treat cluster headache
intervention type: Drug
intervention name: Verapamil
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.
arm group label: Verapamil
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elise VAN OBBERGHEN
phone: +33 4 92 03 75 53
email: vanobberghen.e@chu-nice.fr
last name: Maeva GODEMERT
email: godemert@chu-nice.fr
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Cluster Headache
mesh term: Atrioventricular Block
mesh term: Headache
mesh term: Verapamil
sharing ipd: No
ipd description: No data sharing plan ahs been established