Phase 2 Osteoarthritis Trial, Recruiting NCT06096259 Sponsor: Brigham and Women's Hospital Condition: Osteoarthritis
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Phase 2 Osteoarthritis Trial, Recruiting

NCT06096259
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 25 to 45 with an ACL (knee ligament) injury who are planning to have ACL reconstruction surgery within 12 months of their injury
  • People aged 18 to 24 with an ACL injury who scored below 80 on a knee pain scale (called the KOOS Pain score, where 100 is the best possible score), with that score recorded at least 14 days after the injury, and who are planning to have ACL reconstruction surgery within 12 months of their injury

Who may not be able to join:

  • People who have an inflammatory type of arthritis (such as rheumatoid arthritis)
  • People who are pregnant, breastfeeding, or planning to become pregnant in the next 12 months
  • People who have a known medical reason why they cannot take the medication metformin
  • People who are currently taking metformin or a medication called topiramate
  • People who have diabetes or a serious diabetes-related condition called diabetic ketoacidosis
  • People who have kidney problems, either short-term or long-term
  • People who have previously torn the ACL in the same knee being treated, whether or not they had surgery for it
  • People who tore the ACL in their other knee within the past 12 months
  • People who are applying for or currently receiving Workers' Compensation related to their knee injury
  • People whose injured knee shows both joint space narrowing and bone spurs on a standing X-ray
  • People who have a fracture of the upper part of the shinbone (tibial plateau) in the injured knee
  • People who have a certain type of bone chip fracture in the injured knee that will need surgical treatment
  • People who have additional serious ligament injuries in the same knee (to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament) that require surgery
  • People who are unable to have an MRI scan
  • People who are not able to speak and understand English
  • People who have been diagnosed with a cognitive impairment or who are otherwise unable to give informed consent to participate
  • People whose surgery is scheduled fewer than 14 days from the time of their screening appointment, as this does not allow enough time for preparation
  • People whose knee injury occurred more than 6 months before their screening appointment
  • People who, in the opinion of the surgeon running the trial, have a condition or abnormality that could affect their safety or the reliability of the trial results
  • People who are planning to have their ACL reconstructed using a donor graft (allograft) rather than their own tissue

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Morgan H Jones, MD, MPH, Brigham and Women's Hospital

Phone: 617-525-8617

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
6 May 2024
Est. completion
1 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

KOOS Pain Score; Modified MOAKS Cartilage Score

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov