Health TrialsbyHealthPanel

(2R,6R)-Hydroxynorketamine for the Treatment of Neuropathic Pain

ConditionPain, Neuropathic
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRush University Medical Center

About this trial

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. What is the analgesic efficacy of (2R,6R)-HNK on pain intensity and pain qualities in patients with chronic (\>3 month) neuropathic pain (NP). 2. What will be the effective duration of a single infusion of (2R,6R)-HNK in patients with NP. 3. Will (2R,6R)-HNK reduce pain related effects including interference in daily activities of life, sleep disturbances and change the qualities of pain reported by patients.

Participants will receive each of the three study drugs in a random order at 5-week intervals over a 15 week period. The drug will be administered as a 45-minute infusion.

Participants will complete quantitative sensory and pain evaluations and complete patient reported pain outcomes prior to receiving the first study drug and at 7, 14 and 21 and 35 days following study drug administration.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Ketamine

    Drug

    Ketamine will be administered over a 45-minute period.

  • (2R,6R)-hydroxynorketamine

    Drug

    (2R,6R)-Hydroxynorketamine hydrochloride will be administered over a 45-minute period.

  • Saline

    Drug

    Saline will be administered over a 45-minute period.

Treatment groups

25 Participants
are divided into 3 treatment groups
Group A: KetamineActive comparator 1 intervention
Group B: (2R,6R)-hydroxynorketamineExperimental treatment 1 intervention
Group C: SalinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain intensity

Area under the pain by time curve

Time frame
35 days

Secondary outcomes

1

Pain qualities

Change in the AUC's of T-metric score for pain qualities from the PROMIS neuropathic pain qualities questionnaire

Time frame
35 days
2

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.

Time frame
5 weeks
3

Analgesic consumption

Weekly analgesic consumption quantified using the MQS III

Time frame
5 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rush University Medical Center

Lead sponsor

Congressionally Directed Medical Research Programs

Collaborator

Source ClinicalTrials.gov
Apply now