Ketamine HCl Prolonged Release Oral Tablets for CRPS

This open-label trial (n=50) will evaluate the safety, tolerability, and pharmacokinetic profile of Ketamine HCl Prolonged Release (PR) tablets in participants with pain due to complex regional pain syndrome (CRPS).

Conducted by the University of Southern California, the study involves escalating doses of ketamine HCl PR tablets: 80 mg/day, 160 mg/day, and 240 mg/day. Participants will be monitored for dose-limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD).

The trial aims to assess compliance with the dosing regimen, the effectiveness of clinical instruments, and efficacy signals. Participants will undergo health assessments, including physical exams, blood tests, and EKGs, and will keep daily pain diaries.

The study, led by Dr. Steven Richeimer, began in June 2024 and is expected to complete by July 2026.

Trial Details

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic profile of Ketamine HCl Prolonged Release (PR) tablets in participants with pain due to complex regional pain syndrome (CRPS). Additionally, this trial will explore the feasibility of the trial design through dosing compliance, clinical instruments, and efficacy signals.

NCT Number NCT06419985

Data attribution

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