Montelukast for ACL Injury
(MOCHA Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is Montelukast generally safe for human use?
How does the drug Montelukast differ from other treatments for ACL injury?
Montelukast is unique for ACL injury treatment because it is primarily used for asthma and allergies, working by blocking leukotrienes (chemicals in the body that cause inflammation). This is different from typical ACL treatments, which often involve surgery or physical therapy, as Montelukast offers a non-surgical, anti-inflammatory approach.678910
What is the purpose of this trial?
This is a multicenter randomized, placebo-controlled trial to assess whether a 6-month course of oral montelukast after ACL reconstruction reduces systemic markers of inflammation and biochemical and imaging biomarkers of cartilage degradation. This study will specifically target older ACL reconstruction patients with concomitant meniscal injuries as this group is at greatest risk of rapid PTOA progression. Patients will randomly be assigned to receive oral montelukast (10 mg) versus placebo daily for 6 months after surgery.
Research Team
Austin Stone, MD
Principal Investigator
University of Kentucky
Eligibility Criteria
The MOCHA trial is for people aged 25-50 who are having their first ACL reconstruction and also have a meniscus injury. It's not for those without a meniscus tear, with multiple ligament injuries needing more complex surgery, or showing signs of depression or suicidal thoughts at enrollment.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral montelukast (10 mg) or placebo daily for 6 months after ACL reconstruction surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in KOOS, serum prostaglandin E2, T1rho relaxation time, and shape of the medial femoral condyle on MRI
Treatment Details
Interventions
- Montelukast
- Placebo
Montelukast is already approved in United States, Canada, European Union for the following indications:
- Asthma
- Exercise-induced bronchoconstriction
- Allergic rhinitis
- Asthma
- Exercise-induced bronchoconstriction
- Allergic rhinitis
- Asthma
- Exercise-induced bronchoconstriction
- Allergic rhinitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Austin V Stone
Lead Sponsor
Cale Jacobs, PhD
Lead Sponsor
Duke University
Collaborator
The Cleveland Clinic
Collaborator
University of California, San Francisco
Collaborator