<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/NCT02983734</url>
  </required_header>
  <id_info>
    <org_study_id>W81XWH-15-1-0588</org_study_id>
    <nct_id>NCT02983734</nct_id>
  </id_info>
  <brief_title>D-cycloserine: A Novel Treatment for Gulf War Illness (GWDCS)</brief_title>
  <acronym>GWDCS</acronym>
  <official_title>D-cycloserine: A Novel Treatment for Gulf War Illness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University Charles River Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston University Charles River Campus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the efficacy of d-cycloserine (DCS) treatment for&#xD;
      Gulf War Illness (GWI). Gulf War veterans with Gulf War Illness experience numerous chronic&#xD;
      health symptoms, including cognition and fatigue, which reduces their quality of life. Gulf&#xD;
      War veterans are in urgent need of novel treatment plans to tackle elusive symptomatology of&#xD;
      Gulf War Illness. By using the literature of previous studies, the investigators have chosen&#xD;
      to investigate d-cycloserine as a possible candidate for treating GWI, specifically cognitive&#xD;
      symptoms. DCS has been shown to reduce neuroinflammation, regulate glutamate levels, and&#xD;
      improve synaptic functioning in key areas of the brain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our study is a pilot study for the novel treatment of d-cycloserine to treat GWI. Our study&#xD;
      will consist of two experimental groups of equal size (n=28): DCS treatment group and a&#xD;
      placebo group. Participants will be randomized into either group; with a double blind study&#xD;
      design. Participants will be instructed to self-administer their treatment pills once per day&#xD;
      for 28 days. There will be a total of 6 study visits that will include medical and&#xD;
      neuropsychological assessment. The first visit will be for establishing eligibility and&#xD;
      baseline functioning. Three visits (visits 2-4) will occur during the medication trial (day&#xD;
      1, day 2 and two weeks into medication/placebo). Visit 5 will occur around the time&#xD;
      medication/placebo is finished. Visit 6 (follow up) will occur one month after&#xD;
      medication/placebo is complete.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2015</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neuropsychological Test Battery</measure>
    <time_frame>8 weeks per subject</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptom Questionnaires</measure>
    <time_frame>8 weeks per subject</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">56</enrollment>
  <condition>Gulf War Illness</condition>
  <arm_group>
    <arm_group_label>D-cycloserine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>To compare efficacy of the novel therapeutic approach of DCS in improving cognitive functioning in GW veterans with GWI.&#xD;
DCS = d-cycloserine&#xD;
Dosage: 100mg&#xD;
Dosage form: Pill, administered orally&#xD;
Frequency: Daily for four weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebos</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>To provide a control group to compare efficacy of the novel therapeutic approach of DCS in improving cognitive functioning in GW veterans with GWI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>D-cycloserine</intervention_name>
    <description>Partial agonist of N-methyl-D-aspartate (NMDA) receptor</description>
    <arm_group_label>D-cycloserine</arm_group_label>
    <other_name>DCS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Sugar pill</description>
    <arm_group_label>Placebos</arm_group_label>
    <other_name>Placebo control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veterans of the 1991 Gulf War, male or female&#xD;
&#xD;
          -  Physical examination and laboratory findings within normal limits&#xD;
&#xD;
          -  Willingness and ability to participate in the informed consent process and comply with&#xD;
             study protocols&#xD;
&#xD;
          -  Symptom criteria: Meets Gulf War Illness criteria with the cognitive symptom domain&#xD;
             being present. Veteran does not have medical exclusions for Gulf War Illness&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Veteran lacks the capacity to provide consent during the informed consent process&#xD;
&#xD;
          -  Veteran has the one of the following medical exclusion conditions and/or has been&#xD;
             active or received treatment within the past 5 years: Cancer (except nonmelanoma skin&#xD;
             cancer), diabetes (not well managed), seizure disorder, heart disease (except&#xD;
             hypertension), liver disease, kidney disease, Lupus, multiple sclerosis, stroke,&#xD;
             chronic infectious disease, immune disorder/immunosuppression&#xD;
&#xD;
          -  Veteran has a history of a major psychiatric or central nervous system disorder that&#xD;
             can affect cognitive function (ie. epilepsy, brain tumor, Parkinson's Disease)&#xD;
&#xD;
          -  Veteran has been hospitalized in the past 5 years for depression, PTSD, alcohol or&#xD;
             drug dependence&#xD;
&#xD;
          -  Veteran has current suicidal ideation or current alcohol or drug dependence&#xD;
&#xD;
          -  Pregnant women, lactating women, women who are breastfeeding, or women of childbearing&#xD;
             potential who are not using medically accepted forms of contraception&#xD;
&#xD;
          -  Veteran is active duty personnel&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>43 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rosemary Toomey, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Allison Coyne, B.S.</last_name>
    <phone>617-358-3048</phone>
    <email>afcoyne@bu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rosemary Toomey, Ph.D.</last_name>
    <phone>617-358-2037</phone>
    <email>toomey@bu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Boston University</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston University Charles River Campus</investigator_affiliation>
    <investigator_full_name>RosemaryToomey</investigator_full_name>
    <investigator_title>Research Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Gulf War</keyword>
  <keyword>D-cycloserine</keyword>
  <keyword>Neuroinflammation</keyword>
  <keyword>Cognition</keyword>
  <keyword>Memory</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cycloserine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02983734
org study id: W81XWH-15-1-0588
nct id: NCT02983734
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the efficacy of d-cycloserine (DCS) treatment for
      Gulf War Illness (GWI). Gulf War veterans with Gulf War Illness experience numerous chronic
      health symptoms, including cognition and fatigue, which reduces their quality of life. Gulf
      War veterans are in urgent need of novel treatment plans to tackle elusive symptomatology of
      Gulf War Illness. By using the literature of previous studies, the investigators have chosen
      to investigate d-cycloserine as a possible candidate for treating GWI, specifically cognitive
      symptoms. DCS has been shown to reduce neuroinflammation, regulate glutamate levels, and
      improve synaptic functioning in key areas of the brain.
Our study is a pilot study for the novel treatment of d-cycloserine to treat GWI. Our study
      will consist of two experimental groups of equal size (n=28): DCS treatment group and a
      placebo group. Participants will be randomized into either group; with a double blind study
      design. Participants will be instructed to self-administer their treatment pills once per day
      for 28 days. There will be a total of 6 study visits that will include medical and
      neuropsychological assessment. The first visit will be for establishing eligibility and
      baseline functioning. Three visits (visits 2-4) will occur during the medication trial (day
      1, day 2 and two weeks into medication/placebo). Visit 5 will occur around the time
      medication/placebo is finished. Visit 6 (follow up) will occur one month after
      medication/placebo is complete.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Neuropsychological Test Battery
time frame: 8 weeks per subject
measure: Symptom Questionnaires
time frame: 8 weeks per subject
arm group label: D-cycloserine
arm group type: Active Comparator
description: To compare efficacy of the novel therapeutic approach of DCS in improving cognitive functioning in GW veterans with GWI.
DCS = d-cycloserine
Dosage: 100mg
Dosage form: Pill, administered orally
Frequency: Daily for four weeks
arm group label: Placebos
arm group type: Placebo Comparator
description: To provide a control group to compare efficacy of the novel therapeutic approach of DCS in improving cognitive functioning in GW veterans with GWI.
intervention type: Drug
intervention name: D-cycloserine
description: Partial agonist of N-methyl-D-aspartate (NMDA) receptor
arm group label: D-cycloserine
other name: DCS
intervention type: Drug
intervention name: Placebos
description: Sugar pill
arm group label: Placebos
other name: Placebo control
criteria: 
gender: All
minimum age: 43 Years
maximum age: 85 Years
healthy volunteers: No
last name: Rosemary Toomey, Ph.D.
role: Principal Investigator
affiliation: Boston University
last name: Allison Coyne, B.S.
phone: 617-358-3048
email: afcoyne@bu.edu
last name: Rosemary Toomey, Ph.D.
phone: 617-358-2037
email: toomey@bu.edu
facility: 
status: Recruiting
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston University Charles River Campus
investigator full name: RosemaryToomey
investigator title: Research Associate Professor
mesh term: Cycloserine
sharing ipd: No