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New treatment option for Pain, Neuropathic
Official title (2R,6R)-Hydroxynorketamine for the Treatment of Neuropathic Pain
ClinicalTrials.gov ID: NCT05864053
What this study is testing
What is Ketamine?
Ketamine is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for pain, neuropathic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 extremities. The questions that this study will address are: 1.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
You likely can't join if
- people with suspected increased intracranial or intraocular pressure.
- people 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.
- people with severe medical illness including (but not limited to) hepatic, cardiovascular, pulmonary, renal, hematologic, endocrine...
- Clinically significant acute illness in the 2 weeks prior to dosing.
- Inability to effectively communicate with research staff.
See the full eligibility 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.
- people with suspected increased intracranial or intraocular pressure.
- people 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.
- people with severe medical illness including (but not limited to) hepatic, cardiovascular, pulmonary, renal, hematologic, endocrine, gastrointestinal, immunologic, dermatologic, neurologic, oncologic, or psychiatric...
- Clinically significant acute illness in the 2 weeks prior to dosing.
- Inability to effectively communicate with research staff.
- people 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.
- people in the opinion of the PI should not participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.