30 Participants Needed

Montelukast for ACL Injury

(MOCHA Trial)

CJ
AS
Overseen ByAustin Stone, MD, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: Austin V Stone
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Montelukast, also known as Singulair, is generally considered safe for human use, but like any medication, it can have side effects. Some people have reported mood changes, headaches, and stomach pain. It's important to discuss any concerns with your doctor before starting the medication.12345

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 V. Stone, MD, PhD | UK Healthcare

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

I am between 25 and 50 years old.
I have a concurrent meniscus injury.
I am scheduled for my first ACL surgery.

Exclusion Criteria

My surgery revealed I do not have a meniscus tear.
I am scheduled for a corrective surgery.
You have severe symptoms of depression or have thoughts of hurting yourself at the time of joining the study (scoring 15 or higher on a depression questionnaire called PHQ-9).
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral montelukast (10 mg) or placebo daily for 6 months after ACL reconstruction surgery

6 months
Regular visits as per trial protocol

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

6 months
Visits at 10 days, 4 weeks, and 1 year post-surgery

Treatment Details

Interventions

  • Montelukast
  • Placebo
Trial Overview This study tests if taking montelukast (10 mg) daily for 6 months after ACL surgery can lower inflammation and slow down cartilage damage compared to a placebo. Participants will be randomly chosen to get either the drug or placebo.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MontelukastExperimental Treatment1 Intervention
Patients will receive oral montelukast (10 mg) daily for 6 months after surgery.
Group II: PlaceboPlacebo Group1 Intervention
Patients will receive an oral placebo daily for 6 months after surgery.

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

πŸ‡ΊπŸ‡Έ
Approved in United States as Singulair for:
  • Asthma
  • Exercise-induced bronchoconstriction
  • Allergic rhinitis
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Approved in Canada as Singulair for:
  • Asthma
  • Exercise-induced bronchoconstriction
  • Allergic rhinitis
πŸ‡ͺπŸ‡Ί
Approved in European Union as Singulair for:
  • Asthma
  • Exercise-induced bronchoconstriction
  • Allergic rhinitis

Find a Clinic Near You

Who Is Running the Clinical Trial?

Austin V Stone

Lead Sponsor

Trials
5
Recruited
70+

Cale Jacobs, PhD

Lead Sponsor

Trials
5
Recruited
140+

Duke University

Collaborator

Trials
2,495
Recruited
5,912,000+

The Cleveland Clinic

Collaborator

Trials
1,072
Recruited
1,377,000+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

Findings from Research

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) recommends that oral Janus kinase inhibitors (JAKi) should only be used in patients aged 65 and older or those with cardiovascular disease risk factors when no suitable alternatives are available, highlighting safety concerns.
Despite these precautions, the benefit-risk profile of JAKi remains favorable for patients with atopic dermatitis under 65 years old and without cardiovascular or malignancy risk factors, allowing for their use as first-line systemic therapy.
A detailed look at the European Medicines Agency's recommendations for use of Janus kinase inhibitors in patients with atopic dermatitis.Wollenberg, A., Thyssen, JP., Bieber, T., et al.[2023]
Zafirlukast, a leukotriene inhibitor approved for asthma prevention, is generally well-tolerated with convenient dosing and few side effects.
However, there have been reports of serious side effects, including Churg-Strauss syndrome, as demonstrated in a case of a 54-year-old man who developed leukocytoclastic vasculitis, hepatitis, and eosinophilia while on zafirlukast therapy.
Vasculitis induced by zafirlukast therapy.Soy, M., Ozer, H., Canataroglu, A., et al.[2021]
Long-term safety and effectiveness of TNF-alpha inhibitors are being monitored through independent, academia-initiated drug registers in several European countries, which include all licensed biological agents and utilize standardized reporting systems for adverse events.
These registers have identified key safety concerns related to infections, malignancies, cardiovascular events, and pregnancy outcomes, highlighting the importance of ongoing collaboration between regulatory authorities, academia, and pharmaceutical companies for effective pharmacovigilance.
European biologicals registers: methodology, selected results and perspectives.Zink, A., Askling, J., Dixon, WG., et al.[2013]

References

A detailed look at the European Medicines Agency's recommendations for use of Janus kinase inhibitors in patients with atopic dermatitis. [2023]
Vasculitis induced by zafirlukast therapy. [2021]
European biologicals registers: methodology, selected results and perspectives. [2013]
A retrospective comparison of respiratory events with JAK inhibitors or rituximab for rheumatoid arthritis in patients with pulmonary disease. [2022]
Comparison of signal detection of tumour necrosis factor-Ξ± inhibitors using the Korea Adverse Events Reporting System Database, 2005-2016. [2022]
Wrap It! Preventive Antimicrobial Treatment Shows No Negative Effects on Tenocytes and Tendons-A Comprehensive Approach. [2023]
Soaking ACL grafts in vancomycin solution (1 mg/ml) reduces the infection rate without increasing the risk for re-rupture and arthrofibrosis. [2022]
Soaking of Autologous Tendon Grafts in Vancomycin Before Implantation Does Not Lead to Tenocyte Cytotoxicity. [2021]
Primary reconstruction of the medial collateral ligament in combined injury of the medial collateral and anterior cruciate ligaments. Short-term results. [2016]
Special considerations for ACL graft selection in the young, active military patient. [2022]
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