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New Ketamine-Like drug could ease nerve pain without the high

NCT ID NCT05864053

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This study tests a new drug called (2R,6R)-hydroxynorketamine (HNK) for chronic nerve pain in the arms or legs. 25 adults will receive a single infusion of HNK, ketamine, or a placebo in random order, with 5 weeks between each. Researchers will measure pain levels, sleep, and daily function for 5 weeks after each infusion to see how well HNK works and how long the effect lasts.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
(2R,6R)-hydroxynorketamine
What this could lead to
If it works, this could point toward a new painkiller for nerve pain with fewer side effects than ketamine.
What could go wrong
This is a very early, small trial with only 25 people. The drug may not work better than placebo, and side effects are not yet well understood.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Chronic Pain neuralgia Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

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