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NMDA Receptor Antagonist
Hydroxynorketamine for Neuropathic Pain (HNK Trial)
Phase 1 & 2
Recruiting
Led By Asokumar Buvanendran, MD
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Must not have
Subjects with known liver disease
Poor peripheral venous access
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 35 days
Summary
This trial will evaluate the effectiveness and duration of a single infusion of (2R,6R)-HNK on pain, physical function, pain interference, sleep disturbance and quality of life in patients with neuropathic pain.
Who is the study for?
Adults aged 18-80 with chronic neuropathic pain in the extremities, who can read/write English and have a BMI of 18-35 kg/m². Participants should not have widespread pain conditions like fibromyalgia, mental illness, or severe medical issues. They must not be allergic to ketamine, pregnant, or using certain substances prior to drug administration.
What is being tested?
The trial is testing the effectiveness of (2R,6R)-hydroxynorketamine compared to ketamine and saline for reducing neuropathic pain. Patients will receive each treatment through an infusion over a cross-over design with intervals of five weeks between treatments.
What are the potential side effects?
Potential side effects may include reactions similar to those associated with ketamine such as changes in blood pressure or heart rate, dizziness, nausea, mood changes, blurred vision and possibly dissociation or hallucinations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old with chronic nerve pain in my limbs for over 3 months.
Select...
I have been diagnosed with neuropathic pain based on a specific questionnaire.
Select...
My BMI is between 18 and 35, and I weigh between 50 kg and 120 kg.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a known liver condition.
Select...
I have difficulty with blood draws or IV insertions due to poor vein access.
Select...
I am not allergic to ketamine or any medication used in this study.
Select...
I have widespread pain or have been diagnosed with fibromyalgia.
Select...
I have received ketamine for chronic pain before.
Select...
I might have high pressure in my brain or eyes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 35 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~35 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain intensity
Secondary study objectives
Analgesic consumption
Pain qualities
PainDETECT questionnaire screening scores
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: (2R,6R)-hydroxynorketamineExperimental Treatment1 Intervention
(2R,6R)-hydroxynorketamine 0.5mg/kg 45 minute infusion x 1
Group II: KetamineActive Control1 Intervention
Ketamine 0.5mg/kg 45 minute infusion x 1
Group III: SalinePlacebo Group1 Intervention
Saline 45 minute infusion x 1
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Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
436 Previous Clinical Trials
249,227 Total Patients Enrolled
Congressionally Directed Medical Research ProgramsFED
56 Previous Clinical Trials
10,304 Total Patients Enrolled
Asokumar Buvanendran, MDPrincipal InvestigatorRush University Medical Center
10 Previous Clinical Trials
1,396 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a serious illness in the last 2 weeks.I have a known liver condition.I choose not to take pain medication if I feel better.You have a serious medical condition that could make it unsafe for you to participate in the study.You have used tobacco or nicotine products in the last 4 weeks.I have been diagnosed with neuropathic pain based on a specific questionnaire.I am on medication for chronic nerve pain and agree to continue it during the study.I have difficulty with blood draws or IV insertions due to poor vein access.Your blood pressure when lying down is between 90 and 145 for the top number and no more than 90 for the bottom number.My BMI is between 18 and 35, and I weigh between 50 kg and 120 kg.I am not allergic to ketamine or any medication used in this study.I am between 18 and 80 years old with chronic nerve pain in my limbs for over 3 months.Your lab tests for liver function are normal, or if they are not, the doctor doesn't think it's a big problem.You have a current diagnosis of a mental illness.I have widespread pain or have been diagnosed with fibromyalgia.I have received ketamine for chronic pain before.You have consumed alcohol, grapefruit, poppy seeds, Brussel sprouts, pomegranate, broccoli, or char-grilled meat in the last 2 days before taking the drug.I might have high pressure in my brain or eyes.Your heart test should show no major problems, and the QTc interval (a measure of heart rhythm) should be less than 450 milliseconds.Your heart beats between 45 and 100 times per minute when you are resting.
Research Study Groups:
This trial has the following groups:- Group 1: Ketamine
- Group 2: (2R,6R)-hydroxynorketamine
- Group 3: Saline
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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