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Leukotriene Inhibitor

Montelukast for ACL Injury (MOCHA Trial)

Phase < 1
Recruiting
Led By Austin Stone, MD, PhD
Research Sponsored by Austin V Stone
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 25-50
Concomitant meniscus injury
Must not have
Found to not have a meniscus tear at the time of surgery
Undergoing revision procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between visit 4 (4 weeks post surgery) and visit 6 (1 year post surgery)

Summary

This trial will test whether montelukast can reduce markers of inflammation and cartilage degradation in people who have undergone ACL reconstruction, specifically targeting those with additional meniscal injuries who are at greater risk of rapid cartilage degradation.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Montelukast may cause side effects like respiratory issues, fever, headache, sore throat, cough, abdominal pain, diarrhea, influenza-like symptoms but specific side effects in this trial context aren't detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 25 and 50 years old.
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I have a concurrent meniscus injury.
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I am scheduled for my first ACL surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My surgery revealed I do not have a meniscus tear.
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I am scheduled for a corrective surgery.
Select...
I need surgery to fix several torn ligaments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between visit 4 (4 weeks post surgery) and visit 6 (1 year post surgery)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between visit 4 (4 weeks post surgery) and visit 6 (1 year post surgery) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Knee injury and Osteoarthritis Outcome Score (KOOS)
Serum prostaglandin E2
Magnetic Resonance Imaging
+1 more

Side effects data

From 2005 Phase 4 trial • 99 Patients • NCT00189462
16%
Cold/Upper Respiratory Infection
10%
Diarrhea
6%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Montelukast
Placebo

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Montelukast
2008
Completed Phase 4
~15460

Find a Location

Who is running the clinical trial?

Austin V StoneLead Sponsor
4 Previous Clinical Trials
44 Total Patients Enrolled
2 Trials studying Meniscus Tears
43 Patients Enrolled for Meniscus Tears
Duke UniversityOTHER
2,463 Previous Clinical Trials
2,981,830 Total Patients Enrolled
The Cleveland ClinicOTHER
1,057 Previous Clinical Trials
1,371,730 Total Patients Enrolled
1 Trials studying Meniscus Tears
150 Patients Enrolled for Meniscus Tears
University of California, San FranciscoOTHER
2,593 Previous Clinical Trials
14,887,920 Total Patients Enrolled
Cale Jacobs, PhDLead Sponsor
4 Previous Clinical Trials
108 Total Patients Enrolled
Austin Stone, MD, PhDPrincipal InvestigatorUniversity of Kentucky
3 Previous Clinical Trials
39 Total Patients Enrolled
1 Trials studying Meniscus Tears
38 Patients Enrolled for Meniscus Tears

Media Library

Montelukast (Leukotriene Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04572256 — Phase < 1
Meniscus Tears Research Study Groups: Montelukast, Placebo
Meniscus Tears Clinical Trial 2023: Montelukast Highlights & Side Effects. Trial Name: NCT04572256 — Phase < 1
Montelukast (Leukotriene Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04572256 — Phase < 1
~2 spots leftby Apr 2025
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