TTAX03 for the Treatment of Lumbosacral Facet Joint Pain

Status Not yet recruiting

Clinical Trial Summary

This is a pilot study examining the safety and efficacy of a single intra-articular (IA) injection of TTAX03 per joint to relieve severe spinal facet joint (FJ) pain and improve function in subjects with facet joint pain (FJP) in the lumbosacral region. The design is randomized, double blinded, placebo controlled and dose-group sequential.

Clinical Trial Description

This is a Phase 1, randomized, placebo-controlled, double-blinded dose ranging study design with two dose escalation cohorts to be conducted at three sites in the USA. The primary objective is to examine the safety of FJ IA injections with the test article. The fundamental framework for the number of subjects and dose escalation decisions is modeled on the widely utilized phase 1 "3+3" dose escalation design. A second objective is to examine the efficacy of two doses of TTAX03. The efficacy null hypothesis (HO) is that one administration of TTAX03, introduced into each of two or four joints (at one or two levels) by IA injection, will have no more benefit with respect to pain relief and improved function than an equal volume of placebo (sterile saline). The alternate hypothesis (HA) is that TTAX03 will provide a clinically meaningful reduction in pain and improvement in function compared to placebo. An exploratory objective is to examine the potential benefit in terms of reduced need for narcotic pain relief, radiofrequency ablation, or surgical procedures for relief of LBP. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06236308
Study type	Interventional
Source	Tissue Tech Inc.
Contact
Status	Not yet recruiting
Phase	Phase 1
Start date	July 15, 2024
Completion date	November 30, 2025

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