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Clinical Trial NCT05864053 (HNK) for Pain, Neuropathic is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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(2R,6R)-Hydroxynorketamine for the Treatment of Neuropathic Pain (HNK) Phase 1, Phase 2 25 Randomized Double-Blind
Clinical Trial NCT05864053 (HNK) is designed to study Treatment for Pain, Neuropathic. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on 19 September 2024, with plans to enroll 25 participants. Led by Rush University Medical Center, it is expected to complete by 1 December 2026. The latest data from ClinicalTrials.gov was last updated on 7 January 2026.
Brief Summary
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 extr...Show More
Detailed Description
Adult patients (18 to 80 years) with an established diagnosis of chronic (> 3 month) neuropathic pain (NP) of the extremities will be identified and screened for study inclusion. After informed consent is obtained, subject will be randomized into a (2R,6R)-HNK (H), ketamine (K) or saline (S) infusion groups for each of the study drug administration periods. The group sequences for the infusions will be: KSH, HSK, KH...Show More
Official Title
(2R,6R)-Hydroxynorketamine a Novel Therapeutic Analgesic for the Treatment of Neuropathic Pain: A Randomized Double Blind Cross-Over Trial.
Conditions
Pain, NeuropathicPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- HNK
- 21092004
- CP220059 (Other Grant/Funding Number) (Congressionally Directed Medical Research Programs)
NCT ID Number
Start Date (Actual)
2024-09-19
Last Update Posted
2026-01-07
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
25
Study Type
Interventional
PHASE
Phase 1
Phase 2
Phase 2
Status
Recruiting
Keywords
pain
pain, chronic
pain, neuropathic
non-opioid analgesic
ketamine
(2R,6R)-hydroxynorketamine
pain, chronic
pain, neuropathic
non-opioid analgesic
ketamine
(2R,6R)-hydroxynorketamine
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorKetamine Ketamine 0.5mg/kg 45 minute infusion x 1 | Ketamine Ketamine will be administered over a 45-minute period. |
Experimental(2R,6R)-hydroxynorketamine (2R,6R)-hydroxynorketamine 0.5mg/kg 45 minute infusion x 1 | (2R,6R)-hydroxynorketamine (2R,6R)-Hydroxynorketamine hydrochloride will be administered over a 45-minute period. |
Placebo ComparatorSaline Saline 45 minute infusion x 1 | Saline Saline will be administered over a 45-minute period. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Pain intensity | Area under the pain by time curve | 35 days |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Pain qualities | Change in the AUC's of T-metric score for pain qualities from the PROMIS neuropathic pain qualities questionnaire | 35 days |
PainDETECT questionnaire screening scores | Assessing weekly change in PainDETECT screening scores. PainDETECT is a patient-reported pain qualities assessment tool developed to screen for neuropathic pain. The assessment scale is scored from -1 to 38. Total scores of 12 or less indicates nociceptive pain, 13-18 represent possible neuropathic pain, and \>19 represents \>90% likelihood of neuropathic pain. | 5 weeks |
Analgesic consumption | Weekly analgesic consumption quantified using the MQS III | 5 weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
Rush University Medical CenterCongressionally Directed Medical Research ProgramsStudy Responsible Party
Asokumar Buvanendran, Principal Investigator, Interim Chairperson, Department of Anesthesiology, Rush University Medical Center
Study Central Contact
Contact: Robert J McCarthy, Pharm D, 3125630448, [email protected]
Contact: Daniel Torrez, BS, 3129422741, [email protected]
1 Study Locations in 1 Countries
Illinois
Rush University Medical Center, Chicago, Illinois, 60612, United States
Robert J McCarthy, Pharm D, Contact, 3125630448, [email protected]
Daniel Torrez, BS, Contact, 3129422741, [email protected]
Recruiting