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Leukotriene Inhibitor

Montelukast for ACL Injury (MOCHA Trial)

Q: Are octogenarians permitted to partake in this clinical investigation?

This clinical study is searching for qualified participants aged between 25 and 50 years old.

Q: Who fulfills the eligibility criteria for this clinical trial?

To qualify as a potential participant in this clinical trial, individuals must have been diagnosed with degenerative polyarthritis and be between 25 and 50 years old. The total capacity for the study is 30 patients.

Q: What is the upper limit of participants in this clinical examination?

Affirmative. Evidence from clinicaltrials.gov reveals that this medical trial, which initiated recruitment on February 1st 2021, is currently seeking volunteers to join the experiment. The research requires 30 participants based at a single site.

Q: For what conditions is Montelukast usually prescribed?

Montelukast is effective at managing exercise-induced bronchospasm, perennial allergic rhinitis (PAR), seasonal allergies and <a href="https://www.withpower.com/clinical-trials/asthma">asthma</a>.

Q: To what other research studies has Montelukast been applied?

Currently, there are 22 active clinical trials of montelukast with 6 of these studies in phase 3. Of the 221 trial sites across the globe, several have been established in Lexington, <a href="https://www.withpower.com/clinical-trials/kentucky">Kentucky</a>.

Q: Are recruitment efforts ongoing for this clinical trial?

Confirmed, clinicaltrials.gov currently lists this trial as actively recruiting participants. The project was initially announced on February 1st 2021 and has been updated most recently on September 12th 2022.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change between visit 4 (4 weeks post surgery) and visit 6 (1 year post surgery)

Awards & highlights

MOCHA Trial 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.Check my eligibility

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.See study design

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.

MOCHA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 25 and 50 years old.

Select...

I have a concurrent meniscus injury.

Select...

I am scheduled for my first ACL surgery.

MOCHA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between visit 4 (4 weeks post surgery) and visit 6 (1 year post surgery)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Montelukast

Placebo

MOCHA 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

0 / 3Eligibility criteria met

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

2,358 Previous Clinical Trials

3,420,039 Total Patients Enrolled

The Cleveland ClinicOTHER

1,026 Previous Clinical Trials

1,366,046 Total Patients Enrolled

1 Trials studying Meniscus Tears

150 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarians permitted to partake in this clinical investigation?

"This clinical study is searching for qualified participants aged between 25 and 50 years old."

Answered by AI

Who fulfills the eligibility criteria for this clinical trial?

"To qualify as a potential participant in this clinical trial, individuals must have been diagnosed with degenerative polyarthritis and be between 25 and 50 years old. The total capacity for the study is 30 patients."

Answered by AI

What is the upper limit of participants in this clinical examination?

"Affirmative. Evidence from clinicaltrials.gov reveals that this medical trial, which initiated recruitment on February 1st 2021, is currently seeking volunteers to join the experiment. The research requires 30 participants based at a single site."

Answered by AI

For what conditions is Montelukast usually prescribed?

"Montelukast is effective at managing exercise-induced bronchospasm, perennial allergic rhinitis (PAR), seasonal allergies and asthma."

Answered by AI

To what other research studies has Montelukast been applied?

"Currently, there are 22 active clinical trials of montelukast with 6 of these studies in phase 3. Of the 221 trial sites across the globe, several have been established in Lexington, Kentucky."

Answered by AI

Are recruitment efforts ongoing for this clinical trial?

"Confirmed, clinicaltrials.gov currently lists this trial as actively recruiting participants. The project was initially announced on February 1st 2021 and has been updated most recently on September 12th 2022."

Answered by AI

Recent research and studies

TrialsJournal

Montelukast as a Potential Chondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial): Study Protocol for a Double-blind, Randomized, Placebo-controlled Clinical Trial

Jacobs, Cale A., Caitlin E. W. Conley, Virginia Byers Kraus, Drew A. Lansdown, Brian C. Lau, Xiaojuan Li, Sharmila Majumdar, Kurt P. Spindler, Nicole G. Lemaster, and Austin V. Stone. 2022. “Montelukast as a Potential Chondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial): Study Protocol for a Double-blind, Randomized, Placebo-controlled Clinical Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-021-05982-3.

clinicaltrials.govStudy

MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)

Austin V Stone 2021. "MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04572256.