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SL-1002 for Osteoarthritic Knee Pain (COMPASS Trial)
COMPASS Trial Summary
This trial is testing a new injectable drug for knee pain associated with osteoarthritis. The study will enroll a total of 24-108 patients, who will either receive the drug or a placebo. The study will last up to 168 days, including a screening period of up to 28 days.
COMPASS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOMPASS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.COMPASS Trial Design
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Who is running the clinical trial?
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- You currently have fibromyalgia.You have long-term pain that is causing major emotional or social issues.You are 35 years of age or older, and have a BMI of 18.0 to 34.9 kg/m2 and a total body weight of ≥50.0 kg for males and ≥45.5 kg for females.You have KOOS pain subscale score ≥ 19 and ≤ 67 in the index knee.You must agree to use the same hormonal contraceptive throughout the study.Your knee is very loose and unstable according to the doctor's examination.You are allergic or have a sensitivity to contrast dyes used in medical imaging or to certain medications like phenol and lidocaine.You have nerve pain that affects the knee being studied.You have had your lower limb amputated before or have plans to do so in the future.You are experiencing moderate depression as indicated by a PHQ-9 score of over 10.You are a woman who is currently breastfeeding.You have had knee pain from osteoarthritis for at least 6 months that makes it difficult to do everyday activities like walking or standing for long periods of time.You have knee-related issues, such as deformities or other conditions, that significantly affect your ability to walk or perform daily activities.You have serious problems with your liver or kidneys.You have been experiencing knee pain for at least 6 months due to osteoarthritis, which makes it difficult to perform daily activities like walking or standing for long periods.You have a baseline pain score of ≥ 6 on an 11-point NRS scale as \"usual level of pain over the past 24 hours during weight-bearing activities\" for the index knee.You have a recent history of alcohol or drug abuse within one year before the study screening visit.Your heart or vital signs showed some abnormal readings during the first screening visit. If the doctor thinks that they are not significant, you may still be included in the study.You have an infection in your body that is not limited to one area or is near the planned injection site. You can only join the trial once the infection has been treated.You have a physical condition that could significantly change how the study is done as described in the protocol.You have a medical condition or disease that weakens your immune system and it is not under control.You are very thin and have little cushioning under your skin, which could make you more likely to experience a chemical burn during the study.You have been in pain for at least three months and have tried different treatments like exercising, modifying activities and taking painkillers, but the pain persists.You have been experiencing pain for more than 3 months and have already tried different methods to relieve it, such as modifying your activities, exercising at home, avoiding putting weight on the affected area, and taking painkillers (like Tylenol or Advil).
- Group 1: SL-1002
- Group 2: Matching placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is recruitment still underway for this investigation?
"Confirmatively, clinicaltrials.gov elucidates that this medical experiment is currently enlisting volunteers; the research began on June 13th 2022 and was last revised November 21st 2022. 132 participants must be found from seven different study sites."
How widely dispersed is the implementation of this clinical trial across the state?
"This medical trial is being conducted by 7 different sites, such as Pacific Sports and Spine in Eugene, Northwestern University in Chicago, and the University of Utah School of Medicine in Salt Lake City. The remaining 4 locations are scattered across the United States."
How many participants have been recruited into this clinical experiment?
"Saol Therapeutics Inc is looking to enrol 132 qualified patients across two sites: Pacific Sports and Spine in Eugene, Oregon and Northwestern University in Chicago."
Has SL-1002 been sanctioned by the FDA?
"SL-1002 attains a safety score of 2 since the Phase 2 trial indicates that it is protected, though efficacy data has yet to be established."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
How responsive is this trial?
Most responsive sites:
- International Spine, Pain & Performance Center: < 48 hours
Average response time
- < 2 Days
Typically responds via
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