Trial Outcomes & Findings for Neurotropin to Treat Chronic Neuropathic Pain (NCT NCT00006289)
NCT ID: NCT00006289
Last Updated: 2017-08-22
Results Overview
Assessments of pain severity by the patient using a visual analogue scale ranging from 0 to 100 (mm), with 0 = no pain and 100 = maximal pain level. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while investigators were blinded to the treatment code (Drug A and B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin" in place of "drug A or drug B.
TERMINATED
PHASE2
21 participants
VAS of each patient is measured after each 5-week treatment interval with placebo or Neurotropin.
2017-08-22
Participant Flow
Most patients are recruited by direct physician referral or through the Patient Recruitment and Public Liaison (PRPL) office. Potential subjects are determined to be qualified by screening at Clinical Center, NIH in the US.
Patients who have abnormal results from routine laboratory test or are positive for HIV are excluded. Women who are pregnant or positive for pregnancy test are excluded. Also patients who have non-traumatic pain disorders or are obviously have impaired mental capacity are excluded.
Participant milestones
| Measure |
Placebo First, Then Neurotropin
Receive the placebo b.i.d. for 5 weeks and then Neurotropin b.i.d. for 5 weeks (after at least 1 week washout period)
|
Neurotropin First, Then Placebo
Receive Neurotropin b.i.d. for 5 weeks and then the placebo b.i.d. for 5 weeks (after at least 1 week washout period)
|
|---|---|---|
|
First Intervention (5 Weeks)
STARTED
|
11
|
10
|
|
First Intervention (5 Weeks)
COMPLETED
|
10
|
10
|
|
First Intervention (5 Weeks)
NOT COMPLETED
|
1
|
0
|
|
Washout (>= 1 Week)
STARTED
|
10
|
10
|
|
Washout (>= 1 Week)
COMPLETED
|
10
|
10
|
|
Washout (>= 1 Week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (5 Weeks)
STARTED
|
10
|
10
|
|
Second Intervention (5 Weeks)
COMPLETED
|
9
|
9
|
|
Second Intervention (5 Weeks)
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo First, Then Neurotropin
Receive the placebo b.i.d. for 5 weeks and then Neurotropin b.i.d. for 5 weeks (after at least 1 week washout period)
|
Neurotropin First, Then Placebo
Receive Neurotropin b.i.d. for 5 weeks and then the placebo b.i.d. for 5 weeks (after at least 1 week washout period)
|
|---|---|---|
|
First Intervention (5 Weeks)
Adverse Event
|
1
|
0
|
|
Second Intervention (5 Weeks)
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Neurotropin to Treat Chronic Neuropathic Pain
Baseline characteristics by cohort
| Measure |
Placebo First, Then Neurotropin
n=11 Participants
Receive Placebo 4 tabs b.i.d. for 5 weeks and then Neurotropin 4 tabs b.i.d. for 5 weeks (after at least 1 week washout period)
|
Neurotropin First, Then Placebo
n=10 Participants
Receive Neurotropin 4 tabs b.i.d. for 5 weeks and then Placebo 4 tabs b.i.d. for 5 weeks (after at least 1 week washout period)
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
37.3 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
46.5 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
41.7 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: VAS of each patient is measured after each 5-week treatment interval with placebo or Neurotropin.Assessments of pain severity by the patient using a visual analogue scale ranging from 0 to 100 (mm), with 0 = no pain and 100 = maximal pain level. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while investigators were blinded to the treatment code (Drug A and B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin" in place of "drug A or drug B.
Outcome measures
| Measure |
VAS After Placebo Treatment First in G-1
n=7 Participants
This group received placebo 4 tabs b.i.d. for 5 weeks first. VAS was determined at the end of the 5 week-treatment.
|
VAS After Neurotropin Treatment Second in G-1
n=7 Participants
This group received Neurotropin 4 tabs b.i.d. for 5 weeks after at least 1 week "washout" period following the first 5 week interval on placebo. VAS was determined at the end of the 5 week-treatment of Neurotropin.
|
VAS After Neurotropin Treatment First in G-2
n=9 Participants
This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. VAS was determined at the end of the 5 week-treatment.
|
VAS After Placebo Treatment Second in G-2
n=9 Participants
This group received placebo 4 tabs b.i.d. for 5 weeks after at least 1 week "washout" period following the first 5 week interval on Neurotropin. VAS was determined at the end of the 5 week-treatment of placebo.
|
|---|---|---|---|---|
|
Visual Analogue Scale (VAS) of Pain Scores After Administration of Test Drugs (Placebo or Neurotropin )
|
33.6 mm
Standard Error 11.1
|
38.3 mm
Standard Error 8.8
|
36.0 mm
Standard Error 7.6
|
31.1 mm
Standard Error 7.7
|
PRIMARY outcome
Timeframe: NRS of each patient is measured after each five-week treatment interval with placebo or Neurotropin.Assessments of pain severity by the patient using a numeric rating scale ranging from 0 to 10 as a verbal response where 0 = no pain and 10 =maximal pain. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while the investigators are blinded to the treatment code (Drug A or B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin" in place of "drug A or drug B.
Outcome measures
| Measure |
VAS After Placebo Treatment First in G-1
n=7 Participants
This group received placebo 4 tabs b.i.d. for 5 weeks first. VAS was determined at the end of the 5 week-treatment.
|
VAS After Neurotropin Treatment Second in G-1
n=7 Participants
This group received Neurotropin 4 tabs b.i.d. for 5 weeks after at least 1 week "washout" period following the first 5 week interval on placebo. VAS was determined at the end of the 5 week-treatment of Neurotropin.
|
VAS After Neurotropin Treatment First in G-2
n=9 Participants
This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. VAS was determined at the end of the 5 week-treatment.
|
VAS After Placebo Treatment Second in G-2
n=9 Participants
This group received placebo 4 tabs b.i.d. for 5 weeks after at least 1 week "washout" period following the first 5 week interval on Neurotropin. VAS was determined at the end of the 5 week-treatment of placebo.
|
|---|---|---|---|---|
|
Numeric Rating Scale (NRS) of Pain Scores After Administration of Test Drugs (Neurotropin or Placebo)
|
3.0 units on a scale
Standard Deviation 1.1
|
3.3 units on a scale
Standard Deviation 0.9
|
4.0 units on a scale
Standard Deviation 0.8
|
3.1 units on a scale
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: MPQ of each patient is measured after each five-week treatment interval with drug A or drug B.Assessments of pain severity by the patient using a McGill Pain Questionnaire which consists of 3 major classes of word descriptors-sensory, affective and evaluative - that are used by patients to specify subjective pain experience. Each word chosen from descriptor responses to 20 questions is given a value and the sum of the values of the responses provides a score which is an index of the pain severity with a minimum value of 20 and a maximal value of 78. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while investigators are blinded to the treatment code (drug A or B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin" in place of "drug A or drug B.
Outcome measures
| Measure |
VAS After Placebo Treatment First in G-1
n=7 Participants
This group received placebo 4 tabs b.i.d. for 5 weeks first. VAS was determined at the end of the 5 week-treatment.
|
VAS After Neurotropin Treatment Second in G-1
n=7 Participants
This group received Neurotropin 4 tabs b.i.d. for 5 weeks after at least 1 week "washout" period following the first 5 week interval on placebo. VAS was determined at the end of the 5 week-treatment of Neurotropin.
|
VAS After Neurotropin Treatment First in G-2
n=9 Participants
This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. VAS was determined at the end of the 5 week-treatment.
|
VAS After Placebo Treatment Second in G-2
n=9 Participants
This group received placebo 4 tabs b.i.d. for 5 weeks after at least 1 week "washout" period following the first 5 week interval on Neurotropin. VAS was determined at the end of the 5 week-treatment of placebo.
|
|---|---|---|---|---|
|
McGill Pain Questionnaire (MPQ) of Scores After Administration of Test Drugs (Neurotropin or Placebo)
|
22.4 units on a scale
Standard Error 5.9
|
33.1 units on a scale
Standard Error 4.0
|
25.4 units on a scale
Standard Error 4.9
|
27.1 units on a scale
Standard Error 5.7
|
Adverse Events
Placebo First, Then Neurotropin
Neurotropin First, Then Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo First, Then Neurotropin
n=11 participants at risk
Receive the placebo b.i.d. for 5 weeks and then Neurotropin b.i.d. for 5 weeks (after at least 1 week washout period)
|
Neurotropin First, Then Placebo
n=10 participants at risk
Receive Neurotropin b.i.d. for 5 weeks and then the placebo b.i.d. for 5 weeks (after at least 1 week washout period)
|
|---|---|---|
|
Nervous system disorders
worsening of pain
|
9.1%
1/11 • Number of events 1 • Adverse event information will be collected during the treatments and 5 weeks after the completion of study.
Advese event information will be collected by blood test, weekly questionnaire, and self-report of patients.
|
0.00%
0/10 • Adverse event information will be collected during the treatments and 5 weeks after the completion of study.
Advese event information will be collected by blood test, weekly questionnaire, and self-report of patients.
|
Additional Information
Dr. Leorey Saligan (Principal Investigator, former PI: Dr. Raymond Dioone)
National Institute of Nursing Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place