NCT04572256 MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)
| NCT ID | NCT04572256 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Austin V Stone |
| Condition | ACL Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2021-02-01 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2021-02-01 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Undergoing primary ACL reconstruction 2. Age between 25-50 3. Concomitant meniscus injury Exclusion Criteria: 1. Undergoing revision procedures 2. Multiple ligament injuries requiring multiple ligament reconstruction/repair 3. Depressive symptoms and/or those who endorse suicidal ideation at the time of enrollment (PHQ-9 score \>= 15) 4. Found to not have a meniscus tear at the time of surgery
Contact & Investigator
Austin Stone, MD, PhD
PRINCIPAL INVESTIGATOR
University of Kentucky
Frequently Asked Questions
Who can join the NCT04572256 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 50 Years, studying ACL Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04572256 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04572256 currently recruiting?
Yes, NCT04572256 is actively recruiting participants. Contact the research team at austin.stone@uky.edu for enrollment information.
Where is the NCT04572256 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT04572256 clinical trial?
NCT04572256 is sponsored by Austin V Stone. The principal investigator is Austin Stone, MD, PhD at University of Kentucky. The trial plans to enroll 30 participants.