Montelukast for Gulf War Syndrome

((GWI) Trial)

Overseen By Kandice Motley, BS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Baylor College of Medicine

Must not be taking: Montelukast, Moderate interactions

Disqualifiers: Chronic autoimmune, Cancer, Diabetes, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 10 weeks

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you've changed medications for chronic conditions in the past 3 months or if you're taking 2 or more medications that interact with Montelukast.

What data supports the effectiveness of the drug Montelukast for Gulf War Syndrome?

Montelukast is effective in reducing asthma symptoms and allergic reactions by blocking substances in the body that cause inflammation. It has been shown to improve lung function and reduce the need for other asthma medications, which suggests it might help with similar inflammatory conditions. ^{1 2 3 4 5}

Is montelukast generally safe for humans?

Montelukast is generally well-tolerated, but there have been reports of psychiatric side effects like sleep and behavioral disorders, depression, and even suicidal thoughts. These side effects were not confirmed in clinical trials, but caution is advised, especially for those with a history of psychiatric issues. ^{1 6 7 8 9}

How is the drug Montelukast unique for treating Gulf War Syndrome?

Montelukast is unique for treating Gulf War Syndrome because it is a leukotriene receptor antagonist (LTRA) that works by blocking substances in the body called leukotrienes, which are involved in inflammation. This mechanism is different from other treatments, as there are no standard treatments specifically for Gulf War Syndrome. ^{1 3 5 7 10}

What is the purpose of 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.

Research Team

Drew A Helmer, MD

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

This trial is for U.S. Gulf War veterans who served between August 2, 1990, and December 31, 1991, and are experiencing symptoms like somatic pain, fatigue or sleep issues, respiratory or skin conditions, cognitive dysfunction with a specific test score threshold, mood disturbances or gastrointestinal problems. Participants must be able to communicate in English and attend two in-person study visits.

Inclusion Criteria

I experience body pain.

I experience fatigue or have trouble sleeping.

I have symptoms affecting my skin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phone screening

Treatment

Participants receive either Montelukast or placebo for 10 weeks

10 weeks

2 visits (in-person), regular phone contact

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Montelukast

Trial Overview The trial is testing Montelukast (MLK), an FDA-approved asthma drug that may improve brain function by reducing inflammation. It's being compared to a placebo to see if it can help with cognitive and mood issues in veterans with Gulf War Illness.

Participant Groups

Group I: Montelukast Group Experimental Treatment 1 Intervention

Montelukast two capsules of 20 mg (40 mg total) taken by mouth once daily for ten weeks

Group II: Placebo Group Placebo Group 1 Intervention

Microcrystalline cellulose two capsules taken by mouth once daily for ten weeks

Montelukast is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Singulair for:

• Asthma
• Exercise-induced bronchoconstriction
• Allergic rhinitis

Approved in Canada as Singulair for:

• Asthma
• Exercise-induced bronchoconstriction
• Allergic rhinitis

Approved in European Union as Singulair for:

• Asthma
• Exercise-induced bronchoconstriction
• Allergic rhinitis

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Michael E. DeBakey VA Medical Center

Collaborator

Trials

68

Recruited

17,200+

Texas A&M University

Collaborator

Trials

156

Recruited

28,900+

Findings from Research

Montelukast is effective in improving clinical scores and respiratory function in patients with chronic asthma and in preventing effort-induced asthma, based on several placebo-controlled trials.

While montelukast has not been directly compared to all standard treatments for asthma, it may be superior to salmeterol for effort-induced asthma, and it generally has a similar side effect profile to placebo, though rare cases of Churg-Strauss syndrome have been reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Montelukast. No current use for asthma. [2021]

Montelukast is an effective treatment for asthma, providing bronchoprotective, bronchodilating, and anti-inflammatory effects, and is recommended for patients whose asthma is not adequately controlled by inhaled corticosteroids.

The drug is well tolerated, does not require serum monitoring, and can be used alongside inhaled corticosteroids to improve symptoms and lung function in both adults and children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharma-clinics. Medication of the month. Montelukast (Singulair)]. Louis, R.[2021]

Montelukast sodium is a safe and effective oral medication that acts as a leukotriene-receptor antagonist, specifically targeting the CysLT1 receptor, making it useful for preventing asthma and allergic rhinitis in both adults and children.

Clinical trials have demonstrated that montelukast effectively reduces inflammation and symptoms associated with asthma and allergic rhinitis, highlighting its role in managing these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of montelukast in the treatment of asthma and allergic rhinitis. Nayak, A.[2021]

A study involving 40 healthy male volunteers demonstrated that Sandoz generic montelukast 4 mg oral granules are bioequivalent to Singulair(®) 4 mg mini oral granules, meaning they have similar absorption and effectiveness in the body.

Both formulations showed a comparable safety profile, with only two mild adverse events reported, indicating that they can be used interchangeably in treating asthma and allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioequivalence of two formulations of montelukast sodium 4 mg oral granules in healthy adults. Fey, C., Thyroff-Friesinger, U., Jones, S.[2021]

A retrospective analysis of 14,670 reports found that montelukast is associated with a significant number of psychiatric disorders in children and adolescents, with 2630 cases specifically linked to these age groups.

The study revealed that suicidal behavior was notably over-represented among children and adolescents taking montelukast, indicating a need for increased awareness and monitoring of neuropsychiatric side effects in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychiatric Disorders and Montelukast in Children: A Disproportionality Analysis of the VigiBase(®). Aldea Perona, A., García-Sáiz, M., Sanz Álvarez, E.[2021]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Montelukast. No current use for asthma. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Montelukast for prevention and treatment of asthma exacerbations in adults: Systematic review and meta-analysis. [2022]

3. Belgium pubmed.ncbi.nlm.nih.gov

[Pharma-clinics. Medication of the month. Montelukast (Singulair)]. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment with 400 microg of inhaled budesonide vs 200 microg of inhaled budesonide and oral montelukast in children with moderate persistent asthma: randomized controlled trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A review of montelukast in the treatment of asthma and allergic rhinitis. [2021]

6. France pubmed.ncbi.nlm.nih.gov

[Psychiatric disorders associated with montelukast: data from the National Pharmacovigilance Database]. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Montelukast use during pregnancy: a multicentre, prospective, comparative study of infant outcomes. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Bioequivalence of two formulations of montelukast sodium 4 mg oral granules in healthy adults. [2021]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Psychiatric Disorders and Montelukast in Children: A Disproportionality Analysis of the VigiBase(®). [2021]

10. North Macedonia pubmed.ncbi.nlm.nih.gov

Prevalence of Montelukast Use as an Add-On Therapy among Iraqi Asthmatics on Treatment Attending Al-Kindy Teaching Hospital and Al-Zahraa Center of Asthma and Allergy. [2020]