NCT04466410

Safety and Efficacy of XT-150 for Treatment of Neuropathic Pain

A Double Blind, Placebo Controlled, Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Neuropathic Pain

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Xalud Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Neuropathic Pain. Intrathecally administered, single injection.

Detailed description

XT-150 has been safe and well tolerated in clinical studies of intra-articular knee injections for osteoarthritis. This is the initial study of XT-150 for treatment of neuropathic pain. For this indication XT-150 must be administered by intrathecal injection. Doses used in the osteoarthritis studies will be studied for neuropathic pain. Upon safety reviews, doses will be increased by cohorts. The study is placebo controlled and blinded.

Conditions

• Neuropathic Pain

Interventions

Type	Name	Description
BIOLOGICAL	XT-150	Single bolus intrathecal injection
BIOLOGICAL	Placebo	Placebo is a sterile phosphate-buffered saline

Timeline

• Start date: 2021-04-14
• Primary completion: 2022-09-27
• Completion: 2022-09-27
• First posted: 2020-07-10
• Last updated: 2023-01-23

Locations

4 sites across 1 country: Australia