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

NCT05864053 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-01-07

No results posted yet for this study

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.

Conditions

  • Pain, Neuropathic

Interventions

DRUG

Ketamine

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.

DRUG

Saline

Saline will be administered over a 45-minute period.

Sponsors & Collaborators

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Asokumar Buvanendran, MD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-19
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05864053 on ClinicalTrials.gov