<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/NCT04455633</url>
  </required_header>
  <id_info>
    <org_study_id>LX9211.1-201-DPN</org_study_id>
    <secondary_id>LX9211.201</secondary_id>
    <nct_id>NCT04455633</nct_id>
  </id_info>
  <brief_title>Efficacy, Safety, and PK of LX9211 in Patients With Diabetic Peripheral Neuropathic Pain</brief_title>
  <acronym>RELIEF-DPN 1</acronym>
  <official_title>A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LX9211 in the Treatment of Diabetic Peripheral Neuropathic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lexicon Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lexicon Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of the efficacy of a low and high dose of LX9211 compared to placebo in reducing&#xD;
      pain related to diabetic peripheral neuropathy over an 11 week assessment period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Actual">June 28, 2022</completion_date>
  <primary_completion_date type="Actual">May 23, 2022</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Average Daily Pain Score (ADPS)</measure>
    <time_frame>Day 1 to Week 6</time_frame>
    <description>The change from Baseline (Day 1) to Week 6 in Average Daily Pain Score (ADPS), based on the 11-point numerical rating scale (NRS) (0 [no pain] to 10 [worst imaginable pain])</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>≥30% reduction in pain intensity</measure>
    <time_frame>Day 1 to Week 6</time_frame>
    <description>Proportion of patients with ≥30% reduction in pain intensity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>≥50% reduction in pain intensity</measure>
    <time_frame>Day 1 to Week 6</time_frame>
    <description>Proportion of patients with ≥50% reduction in pain intensity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: # of AEs reported</measure>
    <time_frame>Day 1 to Week 6</time_frame>
    <description># of Adverse Events</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">319</enrollment>
  <condition>Diabetic Peripheral Neuropathy</condition>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>LX9211 low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LX9211, once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LX9211 high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LX9211, once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LX9211 low dose</intervention_name>
    <description>11-week assessment period</description>
    <arm_group_label>LX9211 low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LX9211 high dose</intervention_name>
    <description>11-week assessment period</description>
    <arm_group_label>LX9211 high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LX9211 Placebo</intervention_name>
    <description>11-week assessment period</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient has given written informed consent to participate in the study in accordance&#xD;
             with local regulations&#xD;
&#xD;
          -  Adult male and female patients ≥18 years of age at the time of screening&#xD;
&#xD;
          -  Body mass index ≥18.0 to ≤40.0 kg/m2 at Screening&#xD;
&#xD;
          -  Diagnosis of DPNP at Screening&#xD;
&#xD;
          -  Pain from DPN present for at least 6 months&#xD;
&#xD;
          -  A1C ≤11% at screening&#xD;
&#xD;
          -  Stable regimen for the treatment of T1DM or T2DM for ≥1 month prior to Screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of other painful conditions that may confound assessment or self-evaluation&#xD;
             of DPNP&#xD;
&#xD;
          -  History of major depressive episode, active, significant psychiatric disorders&#xD;
&#xD;
          -  History of clinically significant drug or alcohol use disorder&#xD;
&#xD;
          -  History of neurolytic or neurosurgical therapy for DPNP&#xD;
&#xD;
          -  Use of opioid medications for management of DPNP within the 2 months prior to&#xD;
             Screening Visit&#xD;
&#xD;
          -  Use of NSAIDs less than 2 weeks prior to the Screening Visit&#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>Suma Gopinathan, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Lexicon Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site (156)</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85286</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site (162)</name>
      <address>
        <city>Kingman</city>
        <state>Arizona</state>
        <zip>86409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Greenbrae</city>
        <state>California</state>
        <zip>94904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site (167)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>North Hollywood</city>
        <state>California</state>
        <zip>91606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95821</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site (140)</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site (154)</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site (157)</name>
      <address>
        <city>Lake City</city>
        <state>Florida</state>
        <zip>32055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site (166)</name>
      <address>
        <city>Lake City</city>
        <state>Florida</state>
        <zip>32055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34652</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <zip>32789</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site (163)</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>South Dartmouth</city>
        <state>Massachusetts</state>
        <zip>02747</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site (151)</name>
      <address>
        <city>Dearborn</city>
        <state>Michigan</state>
        <zip>48124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site (150)</name>
      <address>
        <city>Farmington Hills</city>
        <state>Michigan</state>
        <zip>48334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site (159)</name>
      <address>
        <city>Sterling Heights</city>
        <state>Michigan</state>
        <zip>48312</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Hazelwood</city>
        <state>Missouri</state>
        <zip>63042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Westfield</city>
        <state>New York</state>
        <zip>14787</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Williamsville</city>
        <state>New York</state>
        <zip>14221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site (153)</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Cary</city>
        <state>North Carolina</state>
        <zip>27518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Morehead City</city>
        <state>North Carolina</state>
        <zip>28557</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site (149)</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78749</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site (168)</name>
      <address>
        <city>Flower Mound</city>
        <state>Texas</state>
        <zip>75028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Pearland</city>
        <state>Texas</state>
        <zip>77584</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lexicon Investigational Site</name>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <zip>98057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <disposition_first_submitted>May 22, 2023</disposition_first_submitted>
  <disposition_first_submitted_qc>May 22, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">May 24, 2023</disposition_first_posted>
  <last_update_submitted>May 22, 2023</last_update_submitted>
  <last_update_submitted_qc>May 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 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>Neuralgia</mesh_term>
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT04455633
org study id: LX9211.1-201-DPN
secondary id: LX9211.201
nct id: NCT04455633
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Evaluation of the efficacy of a low and high dose of LX9211 compared to placebo in reducing
      pain related to diabetic peripheral neuropathy over an 11 week assessment period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from Baseline in Average Daily Pain Score (ADPS)
time frame: Day 1 to Week 6
description: The change from Baseline (Day 1) to Week 6 in Average Daily Pain Score (ADPS), based on the 11-point numerical rating scale (NRS) (0 [no pain] to 10 [worst imaginable pain])
measure: ≥30% reduction in pain intensity
time frame: Day 1 to Week 6
description: Proportion of patients with ≥30% reduction in pain intensity
measure: ≥50% reduction in pain intensity
time frame: Day 1 to Week 6
description: Proportion of patients with ≥50% reduction in pain intensity
measure: Safety: # of AEs reported
time frame: Day 1 to Week 6
description: # of Adverse Events
arm group label: LX9211 low dose
arm group type: Experimental
description: LX9211, once daily
arm group label: LX9211 high dose
arm group type: Experimental
description: LX9211, once daily
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo, once daily
intervention type: Drug
intervention name: LX9211 low dose
description: 11-week assessment period
arm group label: LX9211 low dose
intervention type: Drug
intervention name: LX9211 high dose
description: 11-week assessment period
arm group label: LX9211 high dose
intervention type: Drug
intervention name: LX9211 Placebo
description: 11-week assessment period
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Suma Gopinathan, PhD
role: Study Director
affiliation: Lexicon Pharmaceuticals
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country: United States
responsible party type: Sponsor
mesh term: Neuralgia
mesh term: Peripheral Nervous System Diseases