Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain

NCT02100956 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB00027272
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the effect of oxytocin given into the spinal fluid on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic neuropathic pain.

Conditions

Neuropathic Pain

Keywords

chronic pain; neuropathic pain

Outcome Measures

Primary Outcomes (1)

• Spontaneous Pain From Their Neuropathic Pain Disease

  Pain will be measured by visual analog scale, a 10 cm line with 0/"no pain" on the left end and 10/"pain as worse as can be" on the right end. The subject places a mark on the line and the score is determined by the distance in cm from the "no pain" end.

  240 minutes post injection

Study Arms (2)

Oxytocin, then Placebo

EXPERIMENTAL

The subject first received oxytocin 100 micrograms administered intrathecally (IT). After at least one week, they received normal saline placebo IT.

Drug: oxytocin 100 micrograms; Drug: Normal Saline (preservative free)

Placebo, then Oxytocin

EXPERIMENTAL

The subject first received normal saline placebo intrathecally (IT). After at least one week, they then received oxytocin 100 micrograms administered IT.

Drug: oxytocin 100 micrograms; Drug: Normal Saline (preservative free)

Interventions

oxytocin 100 micrograms DRUG

oxytocin 100 micrograms administered intrathecally (IT)

Oxytocin, then Placebo; Placebo, then Oxytocin

Normal Saline (preservative free) DRUG

Normal Saline (preservative free) administered intrathecally (IT)

Oxytocin, then Placebo; Placebo, then Oxytocin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Weight \< or equal to 240 pounds
• Neuropathic pain for \> 6 months: with primary pain area below the umbilicus

You may not qualify if:

• Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug or lidocaine
• Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data
• Pregnancy
• spinal cord stimulators, chronic intrathecal drug therapy, or oral opioid treatment for \> 3 months at a current dose of \> 100 milligram (mg) morphine per day or equivalent.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• Eisenach JC, Curry RS, Houle TT. Preliminary results from a randomized, controlled, cross-over trial of intrathecal oxytocin for neuropathic pain. Pain Med. 2023 Sep 1;24(9):1058-1065. doi: 10.1093/pm/pnad051.

  PMID: 37084261 DERIVED

MeSH Terms

Conditions

Neuralgia; Chronic Pain

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

This study was terminated early due to slow recruitment and lack of funding.

Results Point of Contact

• Title: Professor James C. Eisenach, MD
• Organization: Wake Forest University School of Medicine

jimeisenach@gmail.com

336-716-4182

Study Officials

• James C. Eisenach, M.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 1, 2014
• Study Start: June 19, 2014
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: October 3, 2023
• Results First Posted: October 3, 2023

Record last verified: 2022-11

Locations

US (1)