Using (2R,6R)-Hydroxynorketamine to treat neuropathic pain

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

This study is testing whether a new treatment called (2R,6R)-Hydroxynorketamine can help people with chronic nerve pain feel better compared to ketamine and saline.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Rush University Medical Center (other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT05864053 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and duration of analgesia of a single infusion of (2R,6R)-Hydroxynorketamine (HNK) compared to ketamine and saline in patients with chronic neuropathic pain of the extremities. Participants will receive each treatment in a randomized order with a 5-week interval between infusions. The study aims to assess pain intensity, pain qualities, physical function, sleep disturbances, and overall quality of life. Safety assessments and various evaluations will be conducted throughout the study to ensure participant well-being.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with a diagnosis of chronic neuropathic pain lasting more than three months.

Not a fit: Patients with acute pain conditions or those outside the specified age and health criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new non-opioid option for managing chronic neuropathic pain.

How similar studies have performed: Other studies have shown promise with similar non-opioid analgesics, but this specific approach with (2R,6R)-HNK is novel.

Eligibility criteria

Inclusion Criteria:

* Adult patients (18 to 75 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.

Where this trial is running

Chicago, Illinois

• Rush University Medical Center — Chicago, Illinois, United States (RECRUITING)

Study contacts

• Principal investigator: Asokumar Buvanendran, MD — Rush University Medical Center
• Study coordinator: Robert J McCarthy, Pharm D

Conditions: Pain, Neuropathic, pain, pain, chronic, pain, neuropathic, non-opioid analgesic, ketamine, -hydroxynorketamine