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

January 14, 2019 updated by: RosemaryToomey, Boston University Charles River Campus

D-cycloserine: A Novel Treatment for Gulf War Illness

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Allison Coyne, B.S.
  • Phone Number: 617-358-3048
  • Email: afcoyne@bu.edu

Study Contact Backup

  • Name: Rosemary Toomey, Ph.D.
  • Phone Number: 617-358-2037
  • Email: toomey@bu.edu

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Boston University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Placebo control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neuropsychological Test Battery
Time Frame: 8 weeks per subject
8 weeks per subject

Secondary Outcome Measures

Outcome Measure
Time Frame
Symptom Questionnaires
Time Frame: 8 weeks per subject
8 weeks per subject

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University Charles River Campus

Investigators

  • Principal Investigator: Rosemary Toomey, Ph.D., Boston University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ANTICIPATED)

September 1, 2019

Study Completion (ANTICIPATED)

September 1, 2019

Study Registration Dates

First Submitted

November 29, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (ESTIMATE)

December 6, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W81XWH-15-1-0588

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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