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Anti-diabetic agent

Metformin for Osteoarthritis After ACL Surgery (PIKASO Trial)

Phase 2

Waitlist Available

Led By Morgan H Jones, MD, MPH

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Plan to undergo ACL reconstruction

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

Awards & highlights

PIKASO Trial Summary

This trial will see if taking metformin can help reduce pain & delay PTOA after ACL surgery. Placebos will be used to compare results & see if the effects are due to the drug or other reasons.

Who is the study for?

This trial is for adults aged 25-45, or those 18-24 with significant preoperative knee pain, who have an ACL tear confirmed by MRI and plan to undergo reconstruction. It's not for individuals with inflammatory arthritis, kidney issues, heavy alcohol use, hepatic disease, pregnancy plans within a year, current metformin users or those with certain other knee injuries.Check my eligibility

What is being tested?

The study tests if metformin can reduce pain and delay post-traumatic osteoarthritis after ACL surgery compared to a placebo (a pill without the drug). Metformin is known as a diabetes medication but may help due to its anti-inflammatory properties.See study design

What are the potential side effects?

While the side effects specific to this trial are not listed here, common side effects of metformin include gastrointestinal symptoms like nausea and diarrhea. Placebos typically do not cause side effects.

PIKASO Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am planning to have ACL reconstruction surgery.

PIKASO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

KOOS Pain Score

Modified MOAKS Cartilage Score

Secondary outcome measures

10m Habitual Walking Speed

3D Gait Biomechanics

Cartilage composition assessed with T1rho, T2

+15 more

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221

13%

Nasopharyngitis

10%

Hyperhidrosis

Hunger

Tremor

Asthenia

Hypoglycaemia

Squamous cell carcinoma of the tongue

Femoral neck fracture

100%

80%

60%

40%

20%

Study treatment Arm

Vildagliptin (LAF237)

Placebo

PIKASO Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MetforminExperimental Treatment1 Intervention

3x500mg metformin HCl extended-release tablets taken orally once a day for 1 year

Group II: PlaceboPlacebo Group1 Intervention

3x metformin placebo tablets matching metformin extended-release taken orally once a day for 1 year

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin

2006

Completed Phase 4

~2430

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,616 Previous Clinical Trials

11,470,436 Total Patients Enrolled

16 Trials studying Osteoarthritis

29,361 Patients Enrolled for Osteoarthritis

Arthritis FoundationOTHER

34 Previous Clinical Trials

45,639 Total Patients Enrolled

11 Trials studying Osteoarthritis

2,266 Patients Enrolled for Osteoarthritis

Morgan H Jones, MD, MPHPrincipal InvestigatorBrigham and Women's Hospital

Frequently Asked Questions

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

Is it possible to join this clinical trial?

"In order to apply for this trial, individuals must be afflicted with osteoarthritis and between 18-45 years of age. 512 participants are required in total."

Answered by AI

Does this experiment seek to involve elderly people over the age of 70?

"According to the inclusion criteria, this trial is open for individuals aged 18-45. For those under 18 and over 65 years of age respectively, there are 38 and 645 clinical trials listed on clinicialtrials.gov available to them."

Answered by AI

What are the potential hazards associated with Metformin consumption?

"Metformin has been assessed and given a score of 2, as it is currently being trialed on Phase 2, with some safety measures established but no data to rely on for efficacy yet."

Answered by AI

Are there numerous healthcare facilities offering this clinical trial in Canada?

"Currently, 9 medical centres are accepting applicants. These include Iowa City, Lexington and Boston as well as 6 other locales. Select the closest one to you in order to avoid excessive travel expenditure if accepted into this trial."

Answered by AI

Is this investigation still recruiting participants?

"Upon investigation of clinicaltrials.gov, we discovered that this medical trial is not presently recruiting volunteers; it was originally posted on December 1st 2023 and last updated on October 19th 2023. Though participation in the current study may be unavailable, there are 691 other trials actively enrolling participants at the moment."

Answered by AI

What is the primary aim of this experiment?

"This trial's primary outcome, which will be measured over a period of 12-24 months, is the Modified MOAKS Cartilage Score. Secondary objectives include assessing patient relevant outcomes such as KOOS Symptoms (7 items), Activities of Daily Living (17 items) and Sport/Recreation Function (5 items). All data for these measures are gathered by self-administered questionnaires on a 0-100 scale with 100 being optimal."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preventing Injured Knees From osteoArthritis: Severity Outcomes

Morgan H. Jones, MD, MPH 2023. "Preventing Injured Knees From osteoArthritis: Severity Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06096259.

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