RECRUITING

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

Conditions

Pain, Neuropathic pain pain, chronic non-opioid analgesic ketamine (2R,6R)-hydroxynorketamine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-19

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05864053

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Adult patients (18 to 80 years) with an established diagnosis of chronic (\> 3 month) NP of the extremities. * Presence of NP as determined at screening using the 10 item Neuropathic Pain Questionnaire (DN4), with a score of ≥4 required for study inclusion. * Ability to read and write English sufficiently to complete study related procedures. * A body mass index (BMI) (weight \[kg\]/height\[m \]) between 18 and 35 kg/m (inclusive) and weighs between 50 kg and 120 kg (110 - 264 pounds). * Blood pressure with subject is in a supine position for approximately 5 minutes between 90 and 145 mmHg systolic and no higher than 90 mmHg diastolic at baseline. * A 12-lead ECG with no clinically significant abnormality as judged by the Investigator and QTc interval ≤ 450 milliseconds at baseline. * Resting pulse rate between 45 and 100 beats per minute. * Clinical laboratory findings and liver function tests within the normal range, or if outside of the normal ranges, deemed not clinically significant in the opinion of the PI. * Agree to provide written informed consent and comply with the rules regarding consumption of alcohol, caffeinated beverages, and tobacco/nicotine products during the study. * Patients may be taking scheduled or as needed medications for their chronic neuropathic pain and agree to continue taking the scheduled medications throughout the study period. * If the subject experiences pain relief they may elect not to take as needed medications.	* Subjects with suspected increased intracranial or intraocular pressure. * Subjects that have previously received ketamine for the treatment of a chronic pain diagnoses. * Previous or current participation in any clinical study with an investigational drug, device, or biologic within 30 days. * Subjects with severe medical illness including (but not limited to) hepatic, cardiovascular, pulmonary, renal, hematologic, endocrine, gastrointestinal, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease that in the opinion of the PI would endanger the safety of the subject or the validity of the study results. * Clinically significant acute illness in the 2 weeks prior to dosing. * Inability to effectively communicate with research staff. * Subjects with known liver disease. * Widespread pain or a diagnosis of fibromyalgia. * Current diagnosis of mental illness. * Pregnancy. * Allergy to ketamine or any study drug. * Consumption of beverages or food that contain alcohol, grapefruit, poppy seeds, Brussel sprouts, pomegranate, broccoli, char-grilled meat within 2 days prior to drug administration. * Use of tobacco or nicotine-containing products within 4 weeks prior to drug administration. * Poor peripheral venous access. * Subjects in the opinion of the PI should not participate in the study.

Inclusion Criteria

Exclusion Criteria

* Adult patients (18 to 80 years) with an established diagnosis of chronic (\> 3 month) NP of the extremities.
* Presence of NP as determined at screening using the 10 item Neuropathic Pain Questionnaire (DN4), with a score of ≥4 required for study inclusion.
* Ability to read and write English sufficiently to complete study related procedures.
* A body mass index (BMI) (weight \[kg\]/height\[m \]) between 18 and 35 kg/m (inclusive) and weighs between 50 kg and 120 kg (110 - 264 pounds).
* Blood pressure with subject is in a supine position for approximately 5 minutes between 90 and 145 mmHg systolic and no higher than 90 mmHg diastolic at baseline.
* A 12-lead ECG with no clinically significant abnormality as judged by the Investigator and QTc interval ≤ 450 milliseconds at baseline.
* Resting pulse rate between 45 and 100 beats per minute.
* Clinical laboratory findings and liver function tests within the normal range, or if outside of the normal ranges, deemed not clinically significant in the opinion of the PI.
* Agree to provide written informed consent and comply with the rules regarding consumption of alcohol, caffeinated beverages, and tobacco/nicotine products during the study.
* Patients may be taking scheduled or as needed medications for their chronic neuropathic pain and agree to continue taking the scheduled medications throughout the study period.
* If the subject experiences pain relief they may elect not to take as needed medications.

* Subjects with suspected increased intracranial or intraocular pressure.
* Subjects that have previously received ketamine for the treatment of a chronic pain diagnoses.
* Previous or current participation in any clinical study with an investigational drug, device, or biologic within 30 days.
* Subjects with severe medical illness including (but not limited to) hepatic, cardiovascular, pulmonary, renal, hematologic, endocrine, gastrointestinal, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease that in the opinion of the PI would endanger the safety of the subject or the validity of the study results.
* Clinically significant acute illness in the 2 weeks prior to dosing.
* Inability to effectively communicate with research staff.
* Subjects with known liver disease.
* Widespread pain or a diagnosis of fibromyalgia.
* Current diagnosis of mental illness.
* Pregnancy.
* Allergy to ketamine or any study drug.
* Consumption of beverages or food that contain alcohol, grapefruit, poppy seeds, Brussel sprouts, pomegranate, broccoli, char-grilled meat within 2 days prior to drug administration.
* Use of tobacco or nicotine-containing products within 4 weeks prior to drug administration.
* Poor peripheral venous access.
* Subjects in the opinion of the PI should not participate in the study.

Contacts and Locations

Study Contact

Robert J McCarthy, Pharm D

CONTACT

3125630448

robert_j_mccarthy@rush.edu

Daniel Torrez, BS

CONTACT

3129422741

daniel_torrez@rush.edu

Principal Investigator

Asokumar Buvanendran, MD

PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Study Locations (Sites)

Rush University Medical Center

Chicago, Illinois, 60612

United States

Collaborators and Investigators

Sponsor: Rush University Medical Center

Asokumar Buvanendran, MD, PRINCIPAL_INVESTIGATOR, Rush University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-19

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-09-19

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

pain
pain, chronic
pain, neuropathic
non-opioid analgesic
ketamine
(2R,6R)-hydroxynorketamine

Additional Relevant MeSH Terms

Pain, Neuropathic