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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT05864053
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Pain, Neuropathic

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Sep 19, 2024
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ketamine
    Ketamine 0.5mg/kg 45 minute infusion x 1
  • Experimental: (2R,6R)-hydroxynorketamine
    (2R,6R)-hydroxynorketamine 0.5mg/kg 45 minute infusion x 1
  • Placebo Comparator: Saline
    Saline 45 minute infusion x 1

Primary Outcome Measure

Pain intensity [ Time Frame: 35 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612
Robert J McCarthy, Pharm D
[email protected]
3125630448
Daniel Torrez, BS
[email protected]
3129422741

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By research site
Rush University Medical Center· Chicago, IL

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