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NCT05864053 · ClinicalTrials.gov registry record · Phase 1
(2R,6R)-Hydroxynorketamine for the Treatment of Neuropathic Pain
A Phase 1 study of Pain, Neuropathic, sponsored by Rush University Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05864053: Recruiting Phase 1 study of Pain, Neuropathic, sponsored by Rush University Medical Center.
NCT05864053 is a Phase 1 study of Pain, Neuropathic that is actively recruiting participants, run by Rush University Medical Center. The registered enrollment target is 25 participants, below the 65-participant average among 5 other Pain, Neuropathic trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05864053, a Phase 1 study of Pain, Neuropathic, is actively recruiting participants, sponsored by Rush University Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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 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.
Primary Outcome
Area under the pain by time curve
Conditions Studied
Interventions
- DRUG Ketamine
- DRUG Saline
- DRUG (2R,6R)-hydroxynorketamine
Study Locations (1)
Illinois
- Rush University Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2024-09-19 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT05864053 shows while recruiting
NCT05864053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 65-participant average among 5 other Pain, Neuropathic trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Pain, Neuropathic appearing as the primary indexed condition, and to 3 interventions - of which Ketamine is the first listed.
NCT05864053 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05864053 about?
NCT05864053 is a clinical study titled "(2R,6R)-Hydroxynorketamine for the Treatment of Neuropathic Pain". 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, p...
What is the current status of trial NCT05864053?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2024-09-19. Estimated completion is 2026-12.
What conditions does trial NCT05864053 study?
This clinical trial studies the following conditions: Pain, Neuropathic.
What interventions are being tested in trial NCT05864053?
The interventions under investigation include: Ketamine (DRUG), Saline (DRUG), (2R,6R)-hydroxynorketamine (DRUG).
Who is sponsoring clinical trial NCT05864053?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05864053 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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