<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/NCT02969629</url>
  </required_header>
  <id_info>
    <org_study_id>0234-11-RMB</org_study_id>
    <nct_id>NCT02969629</nct_id>
  </id_info>
  <brief_title>The Effects of Apomorphine on Experimental and Clinical Pain in Patients With Chronic Radicular Pain</brief_title>
  <official_title>The Effects of the Dopamine Agonist (Apomorphine) on Experimental and Clinical Pain in Patients With Chronic Radicular Pain: a Randomized, Double-blind, Placebo-controlled, Cross-over Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aimed to explore the effect of the dopamine agonist apomorphine on spontaneous pain&#xD;
      intensity and evoked cold clinical and experimental pain in patients with lumbar radicular&#xD;
      neuropathic pain (NP). Patients received either apomorphine or placebo in a randomized&#xD;
      double-blinded manner.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although evidence suggests that dopaminergic systems are involved in pain processing, the&#xD;
      efficacy of dopaminergic interventions in reducing pain remains questionable. This&#xD;
      randomized, double blinded, placebo-controlled, cross-over study was aimed to explore the&#xD;
      effect of the dopamine agonist apomorphine on spontaneous pain intensity and evoked cold&#xD;
      clinical and experimental pain in patients with lumbar radicular neuropathic pain (NP).&#xD;
&#xD;
      Data was collected from 35 patients (18 men, mean age 56.2±13.1 years). The following five&#xD;
      pain measures were tested before (baseline) and 30, 75 and 120 min subsequent to subcutaneous&#xD;
      injection of 1.5 mg apomorphine or placebo in two separate sessions: spontaneous pain&#xD;
      intensity, threshold and tolerance to cold pain in the most painful site in the affected leg&#xD;
      and in a remote healthy site in the dominant hand.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Experimental and clinical cold pain tolerance measured in seconds</measure>
    <time_frame>Up to 120 minutes after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Experimental and clinical cold pain threshold measured in seconds</measure>
    <time_frame>Up to 120 minutes after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spontaneous clinical pain intensity measured on a numeric pain scale (NPS, 0-100)</measure>
    <time_frame>Up to 120 minutes after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>apomorphine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1.5 mg apomorphine, administered subcutaneously</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>saline, administered subcutaneously</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apomorphine</intervention_name>
    <arm_group_label>apomorphine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <arm_group_label>Normal saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Presence of radicular pain for at least 3 months;&#xD;
&#xD;
          2. Average pain level during the last week prior to enrollment &gt; 40 (0-100);&#xD;
&#xD;
          3. No use of a new analgesic drug within 30 days prior to entry to the study and&#xD;
&#xD;
          4. Adults who were capable of understanding the purpose and instructions of the study and&#xD;
             signing an informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy or breastfeeding;&#xD;
&#xD;
          2. Presence of Parkinson's disease or any other extra-pyramidal diseases;&#xD;
&#xD;
          3. History of allergy to the investigational drugs: Apomorphine or Domperidone;&#xD;
&#xD;
          4. History of polyneuropathy and&#xD;
&#xD;
          5. Respiratory depression, dementia, psychotic diseases or hepatic insufficiency&#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_official>
    <last_name>Elon Eisenberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rambam Health Care Campus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rambam Health Care Campus</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 20, 2016</last_update_submitted>
  <last_update_submitted_qc>November 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rambam Health Care Campus</investigator_affiliation>
    <investigator_full_name>Eisenberg Elon MD</investigator_full_name>
    <investigator_title>Head of pain research unit, Institute of pain</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apomorphine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will not be shared.</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/NCT02969629
org study id: 0234-11-RMB
nct id: NCT02969629
lead sponsor: 
has dmc: No
The study aimed to explore the effect of the dopamine agonist apomorphine on spontaneous pain
      intensity and evoked cold clinical and experimental pain in patients with lumbar radicular
      neuropathic pain (NP). Patients received either apomorphine or placebo in a randomized
      double-blinded manner.
Although evidence suggests that dopaminergic systems are involved in pain processing, the
      efficacy of dopaminergic interventions in reducing pain remains questionable. This
      randomized, double blinded, placebo-controlled, cross-over study was aimed to explore the
      effect of the dopamine agonist apomorphine on spontaneous pain intensity and evoked cold
      clinical and experimental pain in patients with lumbar radicular neuropathic pain (NP).

      Data was collected from 35 patients (18 men, mean age 56.2±13.1 years). The following five
      pain measures were tested before (baseline) and 30, 75 and 120 min subsequent to subcutaneous
      injection of 1.5 mg apomorphine or placebo in two separate sessions: spontaneous pain
      intensity, threshold and tolerance to cold pain in the most painful site in the affected leg
      and in a remote healthy site in the dominant hand.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Experimental and clinical cold pain tolerance measured in seconds
time frame: Up to 120 minutes after drug administration
measure: Experimental and clinical cold pain threshold measured in seconds
time frame: Up to 120 minutes after drug administration
measure: Spontaneous clinical pain intensity measured on a numeric pain scale (NPS, 0-100)
time frame: Up to 120 minutes after drug administration
arm group label: apomorphine
arm group type: Experimental
description: 1.5 mg apomorphine, administered subcutaneously
arm group label: Normal saline
arm group type: Placebo Comparator
description: saline, administered subcutaneously
intervention type: Drug
intervention name: Apomorphine
arm group label: apomorphine
intervention type: Drug
intervention name: Normal Saline
arm group label: Normal saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elon Eisenberg, MD
role: Principal Investigator
affiliation: Rambam Health Care Campus
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Rambam Health Care Campus
investigator full name: Eisenberg Elon MD
investigator title: Head of pain research unit, Institute of pain
mesh term: Low Back Pain
mesh term: Apomorphine
sharing ipd: No
ipd description: Individual participant data will not be shared.