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Trial record 65 of 133 for:    Complex Regional Pain Syndrome

Neurotropin to Treat Chronic Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT00006289
Recruitment Status : Terminated (difficulty in the recruitment of patients)
First Posted : September 22, 2000
Results First Posted : June 21, 2016
Last Update Posted : August 22, 2017
Sponsor:
Collaborators:
National Institutes of Health Clinical Center (CC)
National Institute of Neurological Disorders and Stroke (NINDS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Complex Regional Pain Syndrome Type I
Complex Regional Pain Syndrome Type II
Interventions Drug: Placebo
Drug: Neurotropin
Enrollment 21

Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Placebo First, Then Neurotropin Neurotropin First, Then Placebo
Hide Arm/Group Description 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) 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)
Period Title: First Intervention (5 Weeks)
Started 11 10
Completed 10 10
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Period Title: Washout (>= 1 Week)
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Second Intervention (5 Weeks)
Started 10 10
Completed 9 9
Not Completed 1 1
Reason Not Completed
Protocol Violation             1             1
Arm/Group Title Placebo First, Then Neurotropin Neurotropin First, Then Placebo Total
Hide Arm/Group Description 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) 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 of all reporting groups
Overall Number of Baseline Participants 11 10 21
Hide Baseline Analysis Population Description
Clinical evaluation includes blood chemistries (acute care, hepatic panel, and mineral panel) as well as measurements of pain (including allodynia, hyperalgesia, and hyperpathia), edema, autonomic dysfunction (altered skin color, temperature, or sudomotor activity) and extent of movement disorders.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
<=18 years
2
  18.2%
0
   0.0%
2
   9.5%
Between 18 and 65 years
9
  81.8%
9
  90.0%
18
  85.7%
>=65 years
0
   0.0%
1
  10.0%
1
   4.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 21 participants
37.3  (13.2) 46.5  (13.2) 41.7  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
Female
10
  90.9%
5
  50.0%
15
  71.4%
Male
1
   9.1%
5
  50.0%
6
  28.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 10 participants 21 participants
11 10 21
1.Primary Outcome
Title Visual Analogue Scale (VAS) of Pain Scores After Administration of Test Drugs (Placebo or Neurotropin )
Hide Description 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.
Time Frame VAS of each patient is measured after each 5-week treatment interval with placebo or Neurotropin.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VAS After Placebo Treatment First in G-1 VAS After Neurotropin Treatment Second in G-1 VAS After Neurotropin Treatment First in G-2 VAS After Placebo Treatment Second in G-2
Hide Arm/Group Description:
This group received placebo 4 tabs b.i.d. for 5 weeks first. VAS was determined at the end of the 5 week-treatment.
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.
This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. VAS was determined at the end of the 5 week-treatment.
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.
Overall Number of Participants Analyzed 7 7 9 9
Mean (Standard Error)
Unit of Measure: mm
33.6  (11.1) 38.3  (8.8) 36.0  (7.6) 31.1  (7.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VAS After Placebo Treatment First in G-1, VAS After Neurotropin Treatment Second in G-1, VAS After Neurotropin Treatment First in G-2, VAS After Placebo Treatment Second in G-2
Comments Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B, without knowing which drug is Neurotropin or Placebo) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0058
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
2.Primary Outcome
Title Numeric Rating Scale (NRS) of Pain Scores After Administration of Test Drugs (Neurotropin or Placebo)
Hide Description 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.
Time Frame NRS of each patient is measured after each five-week treatment interval with placebo or Neurotropin.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NRS After Placebo Treatment First in G-1 NRS After Neurotropin Treatment Second in G-1 NRS After Neurotropin Treatment First in G-2 NRS After Placebo Treatment Second in G-2
Hide Arm/Group Description:
This group received placebo 4 tabs b.i.d. for 5 weeks first. NRS was determined at the end of the 5 week-treatment.
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. NRS was determined at the end of the 5 week-treatment of Neurotropin.
This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. NRS was determined at the end of the 5 week-treatment.
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. NRS was determined at the end of the 5 week-treatment of placebo.
Overall Number of Participants Analyzed 7 7 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.0  (1.1) 3.3  (0.9) 4.0  (0.8) 3.1  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NRS After Placebo Treatment First in G-1, NRS After Neurotropin Treatment Second in G-1, NRS After Neurotropin Treatment First in G-2, NRS After Placebo Treatment Second in G-2
Comments Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0058
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
3.Primary Outcome
Title McGill Pain Questionnaire (MPQ) of Scores After Administration of Test Drugs (Neurotropin or Placebo)
Hide Description 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.
Time Frame MPQ of each patient is measured after each five-week treatment interval with drug A or drug B.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MPQ After Placebo Treatment First in G-1 MPQ After Neurotropin Treatment Second in G-1 MPQ After Neurotropin Treatment First in G-2 MPQ After Placebo Treatment Second in G-2
Hide Arm/Group Description:
This group received placebo 4 tabs b.i.d. for 5 weeks first. MPQ was determined at the end of the 5 week-treatment.
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. MPQ was determined at the end of the 5 week-treatment of Neurotropin.
This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. MPQ was determined at the end of the 5 week-treatment.
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. MPQ was determined at the end of the 5 week-treatment of placebo.
Overall Number of Participants Analyzed 7 7 9 9
Mean (Standard Error)
Unit of Measure: units on a scale
22.4  (5.9) 33.1  (4.0) 25.4  (4.9) 27.1  (5.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MPQ After Placebo Treatment First in G-1, MPQ After Neurotropin Treatment Second in G-1, MPQ After Neurotropin Treatment First in G-2, MPQ After Placebo Treatment Second in G-2
Comments Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0058
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Time Frame Adverse event information will be collected during the treatments and 5 weeks after the completion of study.
Adverse Event Reporting Description Advese event information will be collected by blood test, weekly questionnaire, and self-report of patients.
 
Arm/Group Title Placebo First, Then Neurotropin Neurotropin First, Then Placebo
Hide Arm/Group Description 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) 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)
All-Cause Mortality
Placebo First, Then Neurotropin Neurotropin First, Then Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo First, Then Neurotropin Neurotropin First, Then Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Placebo First, Then Neurotropin Neurotropin First, Then Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/11 (9.09%)      0/10 (0.00%)    
Nervous system disorders     
worsening of pain   1/11 (9.09%)  1 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
Because of the difficulty in patient recruitment, the interim analysis was performed for the first 16 patients (target was 30). The results are inconclusive due to large variations in pain scores associated with insufficient the number of patients.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Leorey Saligan (Principal Investigator, former PI: Dr. Raymond Dioone)
Organization: National Institute of Nursing Research
Phone: 301-451-1685
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )
ClinicalTrials.gov Identifier: NCT00006289     History of Changes
Other Study ID Numbers: 000200
00-NR-0200 ( Other Identifier: NIH )
First Submitted: September 21, 2000
First Posted: September 22, 2000
Results First Submitted: June 4, 2013
Results First Posted: June 21, 2016
Last Update Posted: August 22, 2017