Phase 3RecruitingAge-related condition
A Study to Evaluate the Efficacy and Safey of PTP-001 (MOTYS™) in Knee Osteoarthritis Patients (MOTION-P)
A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 3 Study of Intra-Articular Administration of an Allogeneic Human Placental Tissue Particulate (PTP-001) for the Treatment of Knee Osteoarthritis
- Sponsor
- Doron Therapeutics Inc. (Industry)
- Enrolment
- 300 planned
- Conditions
- Knee Osteoarthritis
- Interventions
- PTP-01; Placebo control / saline vehicle
- Ages
- adults, older adults
- Registry
- NCT07219771
Full record on ClinicalTrials.gov
From the registry
This is a multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of intra-articular administration of PTP-001 (MOTYS) for the treatment of knee osteoarthritis. The purpose of the trial is to evaluate the efficacy, safety, and tolerability of a single intra-articular injection of PTP-001 compared to placebo over a 52-week period in participants with radiographic and symptomatic knee OA.
Primary outcomes
- Proportion of participants meeting strict responder criteria for improvement in knee function.
- Proportion of participants meeting strict responder criteria for improvement in knee pain.
History
Study completion expected
Primary completion expected
Last registry update
Registered
Started