Evaluating 2R,6R-Hydroxynorketamine Compared to Ketamine and Saline for Treating Neuropathic Pain A Randomized, Double-Blind, Crossover Study in Adults

What this Trial Is About

This research aims to evaluate the effectiveness and duration of pain relief provided by a single infusion of 2R,6R-hydroxynorketamine compared with ketamine and saline in adults with chronic neuropathic pain of the extremities lasting longer than three months. The study is a randomized, double-blind, three-way crossover trial designed to compare these treatments on pain intensity, pain qualities, physical function, pain interference, sleep disturbance, and quality of life. Participants will receive each of the three study drugs2R,6R-hydroxynorketamine, ketamine, and salinein a random order, with each infusion given over 45 minutes and spaced five weeks apart, totaling a 15-week treatment period. The study uses a crossover design where participants experience all treatments in different sequences. Safety and efficacy are monitored throughout, with baseline and follow-up assessments including blood tests, ECGs, and physical exams. During the study, participants will undergo quantitative sensory and pain evaluations before the first treatment and on days 7, 14, 21, and 35 after each infusion. They will also complete patient-reported pain outcome questionnaires to assess changes in pain and related symptoms. Researchers will monitor safety, lab results, vital signs, and liver function throughout the trial. Participants are advised to continue their regular pain medications and use additional analgesics only as needed. The total study duration per participant is approximately 15 weeks of treatment plus assessment periods.

(2R,6R)-Hydroxynorketamine for the Treatment of Neuropathic Pain