NCT02983734

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

3.9 years

First QC Date

November 29, 2016

Last Update Submit

January 14, 2019

Conditions

Gulf War Illness

Keywords

Gulf WarD-cycloserineNeuroinflammationCognitionMemory

Outcome Measures

Primary Outcomes (1)

  • Neuropsychological Test Battery

    8 weeks per subject

Secondary Outcomes (1)

  • Symptom Questionnaires

    8 weeks per subject

Study Arms (2)

D-cycloserine

ACTIVE COMPARATOR

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

Placebos

PLACEBO COMPARATOR

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

Interventions

D-cycloserineDRUG

Partial agonist of N-methyl-D-aspartate (NMDA) receptor

Also known as: DCS
D-cycloserine
PlacebosDRUG

Sugar pill

Also known as: Placebo control
Placebos

Eligibility Criteria

Age43 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Veteran lacks the capacity to provide consent during the informed consent process
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Neuroinflammatory Diseases

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

Nervous System DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOxazolidinonesOxazolesSerineAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Rosemary Toomey, Ph.D.

    Boston University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison Coyne, B.S.

CONTACT

617-358-3048afcoyne@bu.edu

Rosemary Toomey, Ph.D.

CONTACT

617-358-2037toomey@bu.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 6, 2016

Study Start

October 1, 2015

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

January 15, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)