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This is a multicenter, randomized, double-blind, placebo-controlled, single ascending dose escalation study to assess the safety and efficacy of single treatment exposure of an injectable formulation of SL-1002 for the treatment of knee pain associated with osteoarthritis. Phase A of the study will enroll 3 cohorts of 8 patients per cohort, for a total of 24 patients. Patients will be randomized to receive either SL-1002 or placebo in a 3:1 ratio within each given cohort. Phase B of the study will enroll a minimum of 92 up to a maximum of 108 patients. Patients will be randomized to receive either SL-1002 or placebo in a 3:1 ratio at the recommended dose determined from Phase A. The study period will be up to 168 days inclusive of a screening period of up to 28 days.
Enrollment
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Inclusion criteria
Male or female patients 35 years of age or older, with a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2 and a total body weight of ≥50.0 kg for males and ≥45.5 kg for females.
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).
Patients with a baseline average 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 at Screening. The baseline average pain score is computed by finding the mean of the daily NRS pain intensity scores reported during the 7-day run in period.
Patients with Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate) radiologically confirmed osteoarthritis (via x-ray/MRI/CT) within 6 months of study Screening Visit 1.
Patients with a baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale score ≥ 19 and ≤ 67 in the index knee.
Patients taking analgesics, inclusive of membrane stabilizers (e.g., Neurontin/gabapentin) and/or antidepressants (e.g., Cymbalta/duloxetine), for osteoarthritis associated knee pain must be on a stable dose for at least 6 weeks prior to study Screening Visit 1. Patients must agree to not alter the dose of analgesics for the duration of the study without prior approval from the Investigator.
Female patients of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last study drug administration:
Female patients of non-childbearing potential as defined below:
Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause).
Pre-menopausal females with one of the following:
Patients must agree to see one treating physician (study Investigator) for knee pain treatment for study duration.
Patients who have a positive response to a single genicular nerve block of the index knee using 1.5 - 3mL of lidocaine 2% solution administration to the genicular nerves planned for treatment in each cohort (0.5mL per nerve). A positive response to the qualifying lidocaine prognostic block is defined as ≥ 80% pain reduction within 60 minutes of receiving the lidocaine injections and ≥ 80% pain relief for a duration of at least 60 minutes as documented on a standardized 6-hour pain log.
Patients must be able to understand and be able to complete all assessments associated with the study outcome measures.
Patients must be able to understand the informed consent and be willing to provide written informed consent. Patients must be able to comply with the requirements of the protocol for the entire duration of the study.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
132 participants in 2 patient groups, including a placebo group
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Central trial contact
Kiki Diorgu, MD, MBA; Sharon Hamm
Data sourced from clinicaltrials.gov
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