<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/NCT02209155</url>
  </required_header>
  <id_info>
    <org_study_id>R-Verapamil-001</org_study_id>
    <nct_id>NCT02209155</nct_id>
  </id_info>
  <brief_title>R-Verapamil for the Prophylaxis of Episodic Cluster Headache</brief_title>
  <official_title>A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of R-Verapamil in the Prophylaxis of Episodic Cluster Headache</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Center Laboratories, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Center Laboratories, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a double-blinded, randomized, parallel, placebo-controlled phase 2 study to evaluate&#xD;
      the safety and efficacy of R-verapamil in the prophylaxis of episodic cluster headache.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 30 subjects (about 15 per treatment group),will be enrolled and randomized to&#xD;
      receive either R-verapamil or placebo for 2 weeks. The study will consist of a 1-week run-in&#xD;
      period and a 2-week treatment period (R-verapamil or placebo). The total duration of the&#xD;
      study for each treatment group is 3 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the average daily frequency of attacks</measure>
    <time_frame>2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the average daily frequency of attacks</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in intensity of attacks</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in duration of attacks</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in consumption of abortive agents</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient acceptability of treatment</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in headache severity index</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hit-6 disability score</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>R-verapamil and Placebo responders</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse events assessments</measure>
    <time_frame>2 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Episodic Cluster Headache</condition>
  <arm_group>
    <arm_group_label>R-verapamil 75 mg tablet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>375 mg/day; one in the morning, two in the afternoon and two at bedtime daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>one in the morning, two in the afternoon and two at bedtime daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>R-verapamil 75 mg tablet</intervention_name>
    <arm_group_label>R-verapamil 75 mg tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy man or woman between the ages of 18 and 65&#xD;
&#xD;
          -  In good health as determined by medical history and medical examination&#xD;
&#xD;
          -  Has a diagnosis of episodic cluster headache as defined by the International&#xD;
             Classification of Headache Disorders (2nd edition)&#xD;
&#xD;
          -  Has a lifetime prevalence of at least 2 prior cluster bouts - Subjects must experience&#xD;
             at least 7 attacks/week during the run-in baseline period&#xD;
&#xD;
          -  Subjects must have a typical cluster period lasting at least 1 month. Subjects must be&#xD;
             present in active cluster period and the expected remaining duration of the cluster&#xD;
             cycle must be at least 3 weeks from Baseline Day 1 visit&#xD;
&#xD;
          -  Able to differentiate other headache types from cluster headaches&#xD;
&#xD;
          -  Is using or agrees to use a medically acceptable form of contraception(female of&#xD;
             child-bearing potential)&#xD;
&#xD;
          -  Negative urine pregnancy test prior to study entry(female of child-bearing potential)&#xD;
&#xD;
          -  Concomitant medication that, in the opinion of the investigator and the patient's&#xD;
             general practitioner(GP), do not pose an unacceptable risk based upon the prescribing&#xD;
             information for verapamil&#xD;
&#xD;
          -  Able to understand and comply with all study requirements&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant or lactating&#xD;
&#xD;
          -  Subjects who, in the investigators opinion, have a history or have evidence of a&#xD;
             medical or psychiatric condition that would expose them to an increased risk of a&#xD;
             significant adverse event or would interfere with the assessments of efficacy and&#xD;
             tolerability&#xD;
&#xD;
          -  Use of any drug or having any medical condition which might interact adversely with,&#xD;
             or interfere with the action of, the study medication&#xD;
&#xD;
          -  The concomitant use of beta blockers&#xD;
&#xD;
          -  The consumption of grapefruit juice&#xD;
&#xD;
          -  Allergic to or has shown hypersensitivity to verapamil or agents similar to verapamil&#xD;
&#xD;
          -  Abuses opioids or has a history of significant drug or alcohol abuse within the past&#xD;
             year as determined by investigator&#xD;
&#xD;
          -  Has participated in an investigational drug trial in the 30 days prior to the&#xD;
             screening visit&#xD;
&#xD;
          -  Has liver or kidney disease&#xD;
&#xD;
          -  Has a cardiopathology contraindicating verapamil administration&#xD;
&#xD;
          -  Subjects with previous adynamic ileus.&#xD;
&#xD;
          -  Subjects with chronic cluster headache&#xD;
&#xD;
          -  Use of antipsychotic, antidepressants, lithium or other prophylactic treatment less&#xD;
             than one month prior to inclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UCLH/UCL NIHR Clinical Research Facility</name>
      <address>
        <city>London</city>
        <zip>NW1 2BU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>April 9, 2018</last_update_submitted>
  <last_update_submitted_qc>April 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2018</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>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>
  <!-- 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/NCT02209155
org study id: R-Verapamil-001
nct id: NCT02209155
lead sponsor: 
has dmc: No
This is a double-blinded, randomized, parallel, placebo-controlled phase 2 study to evaluate
      the safety and efficacy of R-verapamil in the prophylaxis of episodic cluster headache.
Approximately 30 subjects (about 15 per treatment group),will be enrolled and randomized to
      receive either R-verapamil or placebo for 2 weeks. The study will consist of a 1-week run-in
      period and a 2-week treatment period (R-verapamil or placebo). The total duration of the
      study for each treatment group is 3 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in the average daily frequency of attacks
time frame: 2 weeks
measure: Change in the average daily frequency of attacks
time frame: 1 week
measure: Change in intensity of attacks
time frame: 2 weeks
measure: Change in duration of attacks
time frame: 2 weeks
measure: Change in consumption of abortive agents
time frame: 2 weeks
measure: Patient acceptability of treatment
time frame: 2 weeks
measure: Change in headache severity index
time frame: 2 weeks
measure: Change in Hit-6 disability score
time frame: 2 weeks
measure: R-verapamil and Placebo responders
time frame: 2 weeks
measure: Adverse events assessments
time frame: 2 weeks
arm group label: R-verapamil 75 mg tablet
arm group type: Active Comparator
description: 375 mg/day; one in the morning, two in the afternoon and two at bedtime daily
arm group label: Placebo
arm group type: Placebo Comparator
description: one in the morning, two in the afternoon and two at bedtime daily
intervention type: Drug
intervention name: R-verapamil 75 mg tablet
arm group label: R-verapamil 75 mg tablet
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Cluster Headache
mesh term: Headache
mesh term: Verapamil