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Trial record 22 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

D-cycloserine: A Novel Treatment for Gulf War Illness (GWDCS) (GWDCS)

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ClinicalTrials.gov Identifier: NCT02983734
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
RosemaryToomey, Boston University Charles River Campus

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gulf War Illness Drug: D-cycloserine Drug: Placebos Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: D-cycloserine: A Novel Treatment for Gulf War Illness
Study Start Date : October 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine

Arm Intervention/treatment
Active Comparator: D-cycloserine

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

Drug: D-cycloserine
Partial agonist of N-methyl-D-aspartate (NMDA) receptor
Other Name: DCS

Placebo Comparator: Placebos
To provide a control group to compare efficacy of the novel therapeutic approach of DCS in improving cognitive functioning in GW veterans with GWI.
Drug: Placebos
Sugar pill
Other Name: Placebo control




Primary Outcome Measures :
  1. Neuropsychological Test Battery [ Time Frame: 8 weeks per subject ]

Secondary Outcome Measures :
  1. Symptom Questionnaires [ Time Frame: 8 weeks per subject ]


Information from the National Library of Medicine

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Ages Eligible for Study:   43 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans of the 1991 Gulf War, male or female
  • Physical examination and laboratory findings within normal limits
  • Willingness and ability to participate in the informed consent process and comply with study protocols
  • Symptom criteria: Meets Gulf War Illness criteria with the cognitive symptom domain being present. Veteran does not have medical exclusions for Gulf War Illness

Exclusion Criteria:

  • Veteran lacks the capacity to provide consent during the informed consent process
  • Veteran has the one of the following medical exclusion conditions and/or has been active or received treatment within the past 5 years: Cancer (except nonmelanoma skin cancer), diabetes (not well managed), seizure disorder, heart disease (except hypertension), liver disease, kidney disease, Lupus, multiple sclerosis, stroke, chronic infectious disease, immune disorder/immunosuppression
  • Veteran has a history of a major psychiatric or central nervous system disorder that can affect cognitive function (ie. epilepsy, brain tumor, Parkinson's Disease)
  • Veteran has been hospitalized in the past 5 years for depression, PTSD, alcohol or drug dependence
  • Veteran has current suicidal ideation or current alcohol or drug dependence
  • Pregnant women, lactating women, women who are breastfeeding, or women of childbearing potential who are not using medically accepted forms of contraception
  • Veteran is active duty personnel

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983734


Contacts
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Contact: Allison Coyne, B.S. 617-358-3048 afcoyne@bu.edu
Contact: Rosemary Toomey, Ph.D. 617-358-2037 toomey@bu.edu

Locations
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United States, Massachusetts
Boston University Recruiting
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Boston University Charles River Campus
Investigators
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Principal Investigator: Rosemary Toomey, Ph.D. Boston University

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Responsible Party: RosemaryToomey, Research Associate Professor, Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT02983734     History of Changes
Other Study ID Numbers: W81XWH-15-1-0588
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by RosemaryToomey, Boston University Charles River Campus:
Gulf War
D-cycloserine
Neuroinflammation
Cognition
Memory

Additional relevant MeSH terms:
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Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action