Research Examining Gulf War Illness in Our Nations Service Members

NCT01846182 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: SPLD-016-12F6125
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 2

Brief Summary

At least 1 in 4 of the 700,000 U.S. Veterans who served in the 1990-1991 Gulf War suffer from Gulf War Illness (GWI). Despite considerable research, effective treatments remain elusive. GWI refers to a complex of symptoms that typically include widespread chronic pain, persistent headache, memory and concentration problems, gastrointestinal difficulties, sleep disturbances and unexplained fatigue. These symptoms are similar to that of fibromyalgia syndrome (FMS), another multi-symptom condition. Whereas, effective treatments for GWI have yet to be found, the FDA has approved duloxetine and pregabalin for the treatment of FMS. The lack of progress in finding effective treatments for GWI, and the similarities between GWI and FMS, provides a rationale for determining if these medications can provide relief to Veterans who suffer from GWI. This randomized controlled trial will test the efficacy of Duloxetine and Pregabalin for treating Gulf War Veterans who suffer from GWI.

Conditions

Gulf War Illness

Keywords

Gulf War Illness; Pregabalin; Duloxetine; Gulf War Veterans; Cymbalta; Lyrica

Outcome Measures

Primary Outcomes (1)

• Pain by Likert Scale

  Likert scale of pain rating

  120 days

Secondary Outcomes (1)

• Side Effects

  Assessed every 2 weeks

Other Outcomes (1)

• Multiple and Unreliable

  Assessed every 2 weeks up to 34 weeks

Study Arms (3)

Group 1

ACTIVE COMPARATOR

60 mg of duloxetine in the AM for 20 weeks and placebo in PM

Drug: Duloxetine; Drug: Placebo

Group 2

ACTIVE COMPARATOR

300 mg of pregabalin in the PM for 20 weeks and placebo in AM

Drug: Pregabalin; Drug: Placebo

Group 3

PLACEBO COMPARATOR

placebo in the AM \& PM for 20 weeks

Drug: Placebo

Interventions

Duloxetine DRUG

serotonin norepinephrine reuptake inhibitor

Also known as: Cymbalta

Group 1

Pregabalin DRUG

alpha-2-alpha subunit calcium channel ligand

Also known as: Lyrica

Group 2

Placebo DRUG

Placebo

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 44 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Living in Central Texas near Killeen, Austin, Temple or Waco
• Served on active military duty and deployed to the Persian Gulf region for some period between August 1990 \& July 1991
• English speaking and able to understand the consent form and study questionnaires
• Willing to be randomized to treatment and participate in 1-month follow up
• men \& women between the ages of 43 to 70
• meet Kansas GWI case definition for the diagnosis of GWI
• report a baseline score \> 4 on a 10-point Pain Visual Analog Scale (VAS)

You may not qualify if:

• Unstable or poorly controlled chronic medical illness such as Diabetes type-II, Hypertension (HTN), heart disease, endocrine disorders, narrow angle glaucoma
• Significant Central Nervous System disease including transient ischemic attacks (TIAs) or stroke, Dementia, syncopal episodes, severe head trauma, multiple sclerosis
• Serious or advanced heart disease or clinically relevant abnormal electrocardiogram (ECG), postural hypotension
• Untreated sleep apnea or body mass index placing patients at risk for undiagnosed sleep apnea (BMI\> 35 kg/m2)
• Diabetes type-I and patients with Diabetes type-II associated with peripheral neuropathy, hepatitis, liver failure/cirrhosis
• End stage renal disease
• History of hypersensitivity reaction to pregabalin, duloxetine, venlafaxine; active treatment with duloxetine or pregabalin; History of failure of duloxetine or pregabalin at therapeutic doses; history of angioedema reaction to pregabalin
• Active systemic infectious disease such as tuberculosis and HIV, shingles
• Autoimmune mediated illnesses such as systemic lupus erythematosis, rheumatoid arthritis, scleroderma
• History of mental illness requiring hospitalization (depression, bipolar illness, post traumatic stress disorder, history of suicide attempts, psychosis, schizophrenia spectrum); Current major depression of dysthymia; patients lacking capacity to make medical decisions
• Use of monoamine oxidase inhibitors (MAOIs) within 2 weeks of evaluation; Active ongoing use of the following agents: desvenlafaxine, fenfluramine, linezolid, milnacipran, phentermine, tryptophan, tramadol, opiates
• Current (meets criterion within the last 6 months) for drug or alcohol dependence (except for nicotine and caffeine)
• Cancer other than non-melanoma skin cancers
• Women who are pregnant or desire to become pregnant, breastfeeding, who use unreliable contraception methods
• Those with occupations requiring use and/or operation of hazardous heavy equipment or professional drivers

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Texas A&M University: collaborator

Study Sites (2)

Central Texas Veterans Health Care System, Temple, TX

Temple, Texas, 76504, United States

Location

Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX

Waco, Texas, 76711, United States

Location

MeSH Terms

Interventions

Duloxetine Hydrochloride; Pregabalin

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The study was closed by the sponsor. Recruiting was very difficult and there were multiple irregularities in enrollment, data collection, and study management. The data are unreliable for interpretation.

Results Point of Contact

• Title: Charles J. Foulks, M.D., ACOS/R
• Organization: Central Texas Veterans Health Care System

Charles.Foulks@va.gov

254 743 2643

Study Officials

• Charles J Foulks, M.D.

  Central Texas Veterans Health Care System, Temple, TX

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Three arms comparing placebo to duloxetine and pregabalin

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: May 3, 2013
• Study Start: June 24, 2015
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: March 12, 2021
• Results First Posted: March 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)