150 Participants Needed

SL1002 for Osteoarthritis

Recruiting at 12 trial locations
KD
Overseen ByKiki Diorgu, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Saol Therapeutics Inc
Must be taking: Analgesics
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SL1002 to determine its safety and effectiveness in reducing knee pain for individuals with osteoarthritis, a joint condition causing pain and stiffness. Participants will receive either the actual treatment or a placebo (a harmless substance with no active ingredients) to compare results. The study is blind, so neither participants nor researchers know who receives the treatment or placebo. This trial may suit those with long-term knee pain from osteoarthritis who currently use pain relievers. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the chance to contribute to potentially bringing a new treatment to market.

Do I have to stop taking my current medications for the trial?

The trial information does not clearly state if you need to stop taking your current medications. However, it mentions 'identifiable baseline medications' in the exclusion criteria, which might mean some medications could affect your eligibility. It's best to discuss your specific medications with the trial coordinators.

Is there any evidence suggesting that SL1002 is likely to be safe for humans?

Research has shown that SL1002 was safe in earlier studies. In tests for muscle stiffness, SL1002 met its main safety targets, indicating it is generally well-tolerated. No major safety problems were reported. This suggests that SL1002 could be a safe option for treating long-term knee pain from osteoarthritis.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for osteoarthritis, which often include NSAIDs and corticosteroids, SL1002 offers a new approach by targeting the underlying mechanisms of pain and inflammation more precisely. This experimental drug stands out because it promises to provide relief without the common side effects associated with long-term use of current medications. Researchers are particularly excited about SL1002 because it represents a potential major advancement in managing osteoarthritis symptoms, offering hope for improved quality of life for patients.

What evidence suggests that SL1002 might be an effective treatment for knee pain in osteoarthritis?

Research has shown that SL1002, which participants in this trial may receive, may help relieve knee pain caused by osteoarthritis. People with mild to moderate osteoarthritis have experienced improvements after using SL1002. Testing has confirmed its safety in people with muscle stiffness, suggesting it is generally safe. While detailed results for knee osteoarthritis are still under study, positive outcomes in similar areas are promising. Overall, early findings support SL1002's potential to reduce knee pain from osteoarthritis.12356

Are You a Good Fit for This Trial?

This trial is for men and women over 40 with chronic knee pain from mild to moderate osteoarthritis. Participants should have a certain level of baseline pain, be within specific BMI limits, respond to a diagnostic nerve block, and may be taking baseline analgesics. Those with severe liver or kidney issues, other inflammatory arthritis types, amputations, drug abuse history, or allergies to study agents cannot join.

Inclusion Criteria

Baseline KOOS pain
Compliance with identified study requirements
Body Mass Index (BMI) limits
See 5 more

Exclusion Criteria

Identified underlying physiologic or psychosocial conditions
Patient Health Questionnaire
Identified underlying abnormal laboratory results
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of SL1002 or placebo for the treatment of knee pain

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • SL1002
Trial Overview The trial is testing SL1002 against a placebo (normal saline) in managing knee pain due to osteoarthritis. It's randomized and double-blind which means participants are put into the treatment or placebo group by chance and neither they nor the researchers know who gets what until after the results are collected.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SL1002Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Saol Therapeutics Inc

Lead Sponsor

Trials
3
Recruited
200+

Citations

Phase II Study to Assess Safety and Efficacy of SL-1002 for ...Patients with Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate) radiologically confirmed osteoarthritis (via x-ray/MRI/CT) within 6 months of study ...
Saol Therapeutics Announces Positive Topline Results ...SL-1002 demonstrated a favorable safety profile in adult patients with limb spasticity, achieving the primary safety endpoint of this first-in-human study.
Saol Therapeutics Announces Positive Topline Results ...SL-1002 demonstrated a favorable safety profile in adult patients with limb spasticity, achieving the primary safety endpoint of this first-in-human study.
Phase III Study to Assess the Safety and Efficacy of SL1002 ...This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a single treatment of SL1002 compared to placebo for the ...
Saol Therapeutics Announces Topline Data from the SL ...In addition to the RAISE Spasticity Trial, SL-1002 is also being investigated for the treatment of pain related to osteoarthritis of the knee.
SL-1002 is a novel, chemoneurolytic injection, that utilizes ...The safety of SL-1002 will be assessed throughout the study compared to placebo when used for treating chronic knee pain associated with ...
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