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SL-1002 for Osteoarthritic Knee Pain (COMPASS Trial)
Phase 2
Waitlist Available
Research Sponsored by Saol Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with chronic knee pain resulting from osteoarthritis for greater than 6 months prior to study Screening Visit 1 that interferes with functional activities (e.g., ambulation, prolonged standing, etc.).
Patients currently experiencing continued pain despite receiving at least 3 months of conservative treatments, inclusive of activity modification, home exercise, protective weight bearing, and/or use of analgesics (e.g., acetaminophen or NSAIDs).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to month 3 in 11 point nrs score
Awards & highlights
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.
Who is the study for?
Adults over 35 with a BMI of 18.0-40.0 kg/m2, experiencing knee pain from osteoarthritis for more than 6 months, and not responding to conservative treatments can join this trial. They must have moderate knee arthritis confirmed by imaging, stable medication use, and agree to contraception if applicable. Exclusions include inflammatory conditions like rheumatoid arthritis, recent joint injections or surgery on the knee, drug abuse history, significant heart or lab abnormalities.Check my eligibility
What is being tested?
The study is testing SL-1002's safety and effectiveness in reducing knee pain due to osteoarthritis compared to a placebo. It involves two phases: an initial dose escalation with three groups (24 patients total) followed by a larger phase with up to 108 patients receiving the best dose found in Phase A. Participants are randomly assigned either SL-1002 or placebo at a ratio of 3:1.See study design
What are the potential side effects?
While specific side effects aren't listed here, common risks may include injection site reactions such as pain or swelling, allergic reactions to components of the treatment or placebo, potential worsening of knee symptoms initially after injection.
COMPASS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
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).
COMPASS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to month 3 in 11 point nrs score
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to month 3 in 11 point nrs score
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement of knee pain
Occurrence of treatment emergent adverse events (TEAEs) overall
COMPASS Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SL-1002Experimental Treatment1 Intervention
SL-1002 injectable solution, single dose
Group II: Matching placeboPlacebo Group1 Intervention
Matching placebo injectable solution
Find a Location
Who is running the clinical trial?
Saol Therapeutics IncLead Sponsor
2 Previous Clinical Trials
66 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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).
Research Study Groups:
This trial has the following groups:- Group 1: SL-1002
- Group 2: Matching placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT05470608 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
Texas
District of Columbia
How old are they?
18 - 65
What site did they apply to?
Virginia iSpine Physicians
Precision Spine Care
Other
International Spine, Pain & Performance Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
3+
2
What questions have other patients asked about this trial?
How long does screening take? Will I know if I am accepted or not? Is there compensation for this clinical trial?
PatientReceived no prior treatments
Why did patients apply to this trial?
I had a torn meniscus to both knees with scopes to each. The right knee makes it difficult to go from sitting on the ground to standing up.
PatientReceived 2+ prior treatments
I've tried other methods medications, injections years ago which have not worked for my knee now hoping a clinical trial might help please consider me thank you.
PatientReceived 1 prior treatment
I am at my wit’s end with pain in my knees. I have tried everything short of surgery (which is less effective than was previously believed). I continue to br active despite the pain but it is both unpleasant & discouraging.
PatientReceived 2+ prior treatments
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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