Recruiting at 1 site No phase Knee Osteoarthristis

Knee Osteoarthristis study: NRPT

Official title Study NRPT Feasibility in Knee Osteoarthritis

ClinicalTrials.gov ID: NCT07917403

What this study is testing

What it's testing
to look at Feasibility and Exploratory Clinical and Biomarker Signals of NRPT in Adults with Knee Osteoarthritis

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 80

You may be able to join if

  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the planned 14-week duration of participation.
  • Adults aged 18 to 80 years (inclusive) at the time of consent, of any sex.
  • Unilateral symptomatic radiographic KOA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the tibiofemoral joint of the index knee, as determined...
  • Knee pain in the index knee with a Visual Analogue Scale (VAS) score of 20-80 (on a 0-100 scale) over the prior 7 days at Screening.

You likely can't join if

  • Prior surgical intervention on the index knee (including arthroscopy, ligament reconstruction, osteotomy, or joint replacement).
  • Severe radiographic knee disease (KL grade 4) in the index knee.
  • Bilateral symptomatic radiographic KOA (i.e., KL grade ≥2 with symptomatic pain in both knees).
  • Diagnosis of inflammatory arthritis (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or crystal...
  • Use of systemic corticosteroids, intra-articular corticosteroid or hyaluronic acid injection in the index knee, chondroitin, glucosamine, or other...
  • Self-reported substantive change in physical activity level (initiation of a new exercise program or cessation of regular activity) within the 3...
See the full eligibility criteria
Who can join
  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the planned 14-week duration of participation.
  • Adults aged 18 to 80 years (inclusive) at the time of consent, of any sex.
  • Unilateral symptomatic radiographic KOA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the tibiofemoral joint of the index knee, as determined from a standing knee radiograph obtained within the prior 12 months or at...
  • Knee pain in the index knee with a Visual Analogue Scale (VAS) score of 20-80 (on a 0-100 scale) over the prior 7 days at Screening.
  • No changes in OA-directed therapy (including analgesics, NSAIDs, topical therapies, or non-pharmacologic regimens) in the 3 months prior to Screening.
  • Agreement to refrain from vitamin B3-containing supplements (nicotinic acid, nicotinamide, nicotinamide riboside) and any multivitamin containing these ingredients for at least 14 days prior to Baseline and throughout...
  • Ability to take oral capsule medication and willingness to adhere to the prescribed NRPT regimen.
  • Agreement to adhere to lifestyle considerations specified in Section 5.3 throughout the study.
What rules you out
  • Prior surgical intervention on the index knee (including arthroscopy, ligament reconstruction, osteotomy, or joint replacement).
  • Severe radiographic knee disease (KL grade 4) in the index knee.
  • Bilateral symptomatic radiographic KOA (i.e., KL grade ≥2 with symptomatic pain in both knees).
  • Diagnosis of inflammatory arthritis (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or crystal arthropathy of the index knee).
  • Use of systemic corticosteroids, intra-articular corticosteroid or hyaluronic acid injection in the index knee, chondroitin, glucosamine, or other polyphenol-containing supplements (including resveratrol, curcumin)...
  • Self-reported substantive change in physical activity level (initiation of a new exercise program or cessation of regular activity) within the 3 months prior to Screening.
  • Pregnancy, lactation, or planning pregnancy during the study period. Women of childbearing potential must have a negative serum or urine pregnancy test at Screening.
  • Severe or uncontrolled comorbid conditions that, in the opinion of the investigator, would compromise participant safety or interpretability of study data, including but not limited to: uncontrolled diabetes mellitus...
  • Known allergy or hypersensitivity to nicotinamide riboside, pterostilbene, resveratrol, or any excipient of Basis®.
  • Concurrent participation in another treatment clinical trial or use of an investigational agent within 30 days prior to Screening.
  • Any other condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with the protocol or with the safety or scientific integrity of the study.

The study team makes the final eligibility decision.

Where it is enrolling

  • San Diego, California, United States

Compensation & support

A stipend or payment for your time may be offered.

No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at San Diego, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.