New Ketamine-Like drug could ease nerve pain without the high
NCT ID NCT05864053
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Rush University Medical Center
RECRUITINGChicago, Illinois, 60612, United States
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