Health TrialsbyHealthPanel

Clinical Evaluation of Montelukast in Veterans With Gulf War Illness

ConditionGulf War Syndrome
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50-70
SponsorBaylor College of Medicine

About this trial

The study addresses the pre-clinical promise of Montelukast (MLK) for improving brain function in veterans with Gulf War Illness (GWI). MLK, a US Food and Drug administration (FDA)-approved drug for asthma, has shown efficacy in an animal model of GWI to improve cognitive and mood function through modulation of leukotriene signaling and suppression of neuroinflammation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Gulf War Veterans of the U.S. military deployed on military orders to the Persian Gulf Region between August 2, 1990, and December 31, 1991

fatigue/sleep disturbances

neurological/cognitive/mood symptoms

somatic pain

Disqualifiers

chronic autoimmune conditions

systemic inflammatory conditions

cancer not in remission at least 5 years

congestive heart failure

Trial design

Design model

Parallel

Treatments tested in this trial

  • Montelukast

    Drug

    This group will receive the montelukast treatment.

  • Placebo

    Other intervention

    This group will receive a placebo pill instead of montelukast

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Montelukast GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Leukotriene concentration

Concentrations in the brain-derived extracellular vesicles collected from the circulating peripheral blood.

Time frame
taken at baseline (week 0) and after the intervention (week 10)

Secondary outcomes

1

Change in RCAT (Halstead Category Test-Russell Revised Version)

Instrument designed to measure cognitive function. Scores are reported as T-scores while participant's age, gender, ethnicity, and level of education are controlled. A higher T-score correlates to better executive functioning.

Time frame
taken at baseline (week 0) and after the intervention (week 10)
2

Change in Veterans Rand-36 Physical Component Summary (VR-36 PCS) score

Scores reflect physical health-related quality of life. The scores are reported on a scale 0-100 with 0 being the worst possible score and 100 being the best possible score. The mean score of the US population is 50.

Time frame
taken at baseline (week 0) and after the intervention (week 10)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baylor College of Medicine

Lead sponsor

Michael E. DeBakey VA Medical Center

Collaborator

Texas A&M University

Collaborator

Source ClinicalTrials.gov
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