RecruitingPhase 1Phase 2NCT05864053

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

(2R,6R)-Hydroxynorketamine a Novel Therapeutic Analgesic for the Treatment of Neuropathic Pain: A Randomized Double Blind Cross-Over Trial.


Sponsor

Rush University Medical Center

Enrollment

25 participants

Start Date

Sep 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this randomized double blind three way (1:1:1) cross over clinical trial is to evaluate the effectiveness and duration of analgesia of a single infusion of (2R,6R)-HNK 0.5mg/kg compared with ketamine 0.5mg/kg and saline with a 5-week interval between treatments on pain, pain qualities, physical function, pain interference, sleep disturbance and quality of life in subjects with neuropathic pain of the extremities. The questions that this study will address are: 1. What is the analgesic efficacy of (2R,6R)-HNK on pain intensity and pain qualities in patients with chronic (\>3 month) neuropathic pain (NP). 2. What will be the effective duration of a single infusion of (2R,6R)-HNK in patients with NP. 3. Will (2R,6R)-HNK reduce pain related effects including interference in daily activities of life, sleep disturbances and change the qualities of pain reported by patients. Participants will receive each of the three study drugs in a random order at 5-week intervals over a 15 week period. The drug will be administered as a 45-minute infusion. Participants will complete quantitative sensory and pain evaluations and complete patient reported pain outcomes prior to receiving the first study drug and at 7, 14 and 21 and 35 days following study drug administration.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called (2R,6R)-hydroxynorketamine, a drug called Ketamine, and others for people with pain, neuropathic. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKetamine

Ketamine will be administered over a 45-minute period.

DRUG(2R,6R)-hydroxynorketamine

(2R,6R)-Hydroxynorketamine hydrochloride will be administered over a 45-minute period.

DRUGSaline

Saline will be administered over a 45-minute period.


Locations(1)

Rush University Medical Center

Chicago, Illinois, United States

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NCT05864053


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