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
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
Treatments tested in this trial
- Montelukast
- Placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Baylor College of Medicine
Lead sponsor
Michael E. DeBakey VA Medical Center
Collaborator
Texas A&M University
Collaborator
Source ClinicalTrials.gov