Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05864053
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2023-04-26
Brief Title:
2R6R-Hydroxynorketamine for the Treatment of Neuropathic Pain
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
2R6R-Hydroxynorketamine a Novel Therapeutic Analgesic for the Treatment of Neuropathic Pain a Randomized Double Blind Cross-Over Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HNK
Brief Summary:
The goal of this randomized double blind three way 111 cross over clinical trial is to evaluate the effectiveness and duration of analgesia of a single infusion of 2R6R-HNK 05mgkg compared with ketamine 05mgkg 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 2R6R-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 2R6R-HNK in patients with NP
3 Will 2R6R-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
The questions that this study will address are
1 What is the analgesic efficacy of 2R6R-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 2R6R-HNK in patients with NP
3 Will 2R6R-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
Detailed Description:
Adult patients 18 to 80 years with an established diagnosis of chronic 3 month neuropathic pain NP of the extremities will be identified and screened for study inclusion After informed consent is obtained subject will be randomized into a 2R6R-HNK H ketamine K or saline S infusion groups for each of the study drug administration periods The group sequences for the infusions will be KSH HSK KHS SKH and HKS and each group will contain 5 subjects at each sequence Study subjects will be evaluated for at least 7 days prior to the first treatment and for 35 days following each treatment Researchers involved in the subjects care and assessments will be blinded to group allocation Safety will be assessed throughout the study Baseline safety assessments will include height body mass index BMI weight temperature medical visual and ocular history physical examinations and vital signs VS Prior to study commencement and 28 days after each drug infusion a blood chemistry panel liver function tests LFT a complete blood count CBC and a 12-lead electrocardiogram ECG will be obtained A pretreatment quantitative pain evaluation will assess overall pain level pain tolerance pinprick hyperalgesia touch brush and cold allodynia Patients will be maintained on their current scheduled analgesic regimen during the study and instructed to use on-demand analgesic only as needed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CP220059 | OTHER_GRANT | Congressionally Directed Medical Research Programs | None |