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

Launched by RUSH UNIVERSITY MEDICAL CENTER · May 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called (2R,6R)-Hydroxynorketamine (HNK) to see how well it can help relieve neuropathic pain, which is a type of chronic pain that can occur in the arms or legs. The trial will compare the effects of a single infusion of (2R,6R)-HNK to a similar infusion of ketamine and a placebo (saline solution), to find out which treatment is more effective in relieving pain, improving sleep, and enhancing overall quality of life. Participants will receive each of the three treatments in a random order, with a break of five weeks in between each session. The study will last about 15 weeks and will involve various assessments of pain and daily function.

To be eligible for this trial, you must be an adult between 18 and 80 years old with chronic neuropathic pain that has lasted for more than three months. You should have a specific score on a pain questionnaire and meet certain health criteria, including having a healthy body weight and no significant heart or liver problems. During the trial, participants will receive the treatment over a 45-minute period and will complete surveys about their pain before and after the infusion. It's important to note that participants should be able to read and write in English and should agree to follow specific guidelines about medications and diet during the study. If you think you might be eligible and are interested in helping advance treatment options for neuropathic pain, this trial could be a good opportunity.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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.