Trial Outcomes & Findings for Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain (NCT NCT02100956)
NCT ID: NCT02100956
Last Updated: 2023-10-03
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
240 minutes post injection
Results posted on
2023-10-03
Participant Flow
Two subjects were not randomized, one because of an abnormal electrocardiogram and the other for lack of spontaneous neuropathic pain at rest. Six subjects were randomized and received the first intrathecal injection. Participant flow section includes randomized subjects only.
Participant milestones
| Measure |
Oxytocin, Then Placebo
The subject first received oxytocin 100 micrograms administered intrathecally (IT). After at least one week, they received normal saline placebo IT.
oxytocin 100 micrograms: oxytocin 100 micrograms administered intrathecally (IT)
Normal Saline (preservative free): Normal Saline (preservative free) administered intrathecally (IT)
|
Placebo, Then Oxytocin
The subject first received normal saline placebo intrathecally (IT). After at least one week, they then received oxytocin 100 micrograms administered IT.
oxytocin 100 micrograms: oxytocin 100 micrograms administered intrathecally (IT)
Normal Saline (preservative free): Normal Saline (preservative free) administered intrathecally (IT)
|
|---|---|---|
|
First Injection
STARTED
|
3
|
3
|
|
First Injection
COMPLETED
|
3
|
3
|
|
First Injection
NOT COMPLETED
|
0
|
0
|
|
At Least One Week Between Injections
STARTED
|
3
|
3
|
|
At Least One Week Between Injections
COMPLETED
|
3
|
2
|
|
At Least One Week Between Injections
NOT COMPLETED
|
0
|
1
|
|
Second Injection
STARTED
|
3
|
2
|
|
Second Injection
COMPLETED
|
3
|
2
|
|
Second Injection
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Oxytocin, Then Placebo
The subject first received oxytocin 100 micrograms administered intrathecally (IT). After at least one week, they received normal saline placebo IT.
oxytocin 100 micrograms: oxytocin 100 micrograms administered intrathecally (IT)
Normal Saline (preservative free): Normal Saline (preservative free) administered intrathecally (IT)
|
Placebo, Then Oxytocin
The subject first received normal saline placebo intrathecally (IT). After at least one week, they then received oxytocin 100 micrograms administered IT.
oxytocin 100 micrograms: oxytocin 100 micrograms administered intrathecally (IT)
Normal Saline (preservative free): Normal Saline (preservative free) administered intrathecally (IT)
|
|---|---|---|
|
At Least One Week Between Injections
Adverse Event
|
0
|
1
|
Baseline Characteristics
Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain
Baseline characteristics by cohort
| Measure |
Oxytocin, Then Placebo
n=3 Participants
The subject first received oxytocin 100 micrograms administered intrathecally (IT). After at least one week, they received normal saline placebo IT.
oxytocin 100 micrograms: oxytocin 100 micrograms administered intrathecally (IT)
Normal Saline (preservative free): Normal Saline (preservative free) administered intrathecally (IT)
|
Placebo, Then Oxytocin
n=3 Participants
The subject first received normal saline placebo intrathecally (IT). After at least one week, they then received oxytocin 100 micrograms administered IT.
oxytocin 100 micrograms: oxytocin 100 micrograms administered intrathecally (IT)
Normal Saline (preservative free): Normal Saline (preservative free) administered intrathecally (IT)
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
n=5 Participants
|
54 years
n=7 Participants
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Visual Analog Scale Pain
|
4.2 units on a scale
n=5 Participants
|
2.6 units on a scale
n=7 Participants
|
3.9 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 240 minutes post injectionPopulation: The intention to treat population was defined as individuals who were randomized and received intrathecal drug on both study days of the trial. This includes subjects who completed both injections.
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.
Outcome measures
| Measure |
Oxytocin Injection
n=5 Participants
Participants who received intrathecal oxytocin injection on either the first or second study day
|
Placebo Injection
n=5 Participants
Patients who received normal saline placebo injection on either the first or second study day.
|
|---|---|---|
|
Spontaneous Pain From Their Neuropathic Pain Disease
|
1.67 score on a scale
Standard Error 0.87
|
2.43 score on a scale
Standard Error 0.89
|
Adverse Events
Oxytocin Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Injection
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxytocin Injection
n=6 participants at risk
Participants who received intrathecal oxytocin injection on either the first or second study day
|
Placebo Injection
n=6 participants at risk
Patients who received normal saline placebo injection on either the first or second study day.
|
|---|---|---|
|
Nervous system disorders
Post dural puncture headache
|
0.00%
0/6 • 6 months after second intrathecal injection, up to 6.5 months
Peripheral oxyhemoglobin saturation, blood pressure, and heart rate were measured non invasively and recorded before and 15, 30, 60, 120, 180, 240, minutes after intrathecal injection. The electrocardiogram was continuously monitored. A neurologic examination was performed at intervals until 24 hours after injection. Serum sodium was assayed 24 hr after injection. Subjects were called 2, 3, 4, 5, 7 days, then weekly until one month and then at 6 months after the second intrathecal injection.
|
16.7%
1/6 • Number of events 1 • 6 months after second intrathecal injection, up to 6.5 months
Peripheral oxyhemoglobin saturation, blood pressure, and heart rate were measured non invasively and recorded before and 15, 30, 60, 120, 180, 240, minutes after intrathecal injection. The electrocardiogram was continuously monitored. A neurologic examination was performed at intervals until 24 hours after injection. Serum sodium was assayed 24 hr after injection. Subjects were called 2, 3, 4, 5, 7 days, then weekly until one month and then at 6 months after the second intrathecal injection.
|
Additional Information
Professor James C. Eisenach, MD
Wake Forest University School of Medicine
Phone: 336-716-4182
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place