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Neurotropin to Treat Chronic Neuropathic Pain

This study has been terminated.
(difficulty in the recruitment of patients)
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) )
ClinicalTrials.gov Identifier:
NCT00006289
First received: September 21, 2000
Last updated: May 12, 2016
Last verified: May 2016
Results First Received: June 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Complex Regional Pain Syndrome Type I
Complex Regional Pain Syndrome Type II
Interventions: Drug: Placebo
Drug: Neurotropin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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)

Participant Flow for 3 periods

Period 1:   First Intervention (5 Weeks)
    Placebo First, Then Neurotropin     Neurotropin First, Then Placebo  
STARTED     11     10  
COMPLETED     10     10  
NOT COMPLETED     1     0  
Adverse Event                 1                 0  

Period 2:   Washout (>= 1 Week)
    Placebo First, Then Neurotropin     Neurotropin First, Then Placebo  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     0  

Period 3:   Second Intervention (5 Weeks)
    Placebo First, Then Neurotropin     Neurotropin First, Then Placebo  
STARTED     10     10  
COMPLETED     9     9  
NOT COMPLETED     1     1  
Protocol Violation                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Placebo First, Then Neurotropin 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 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 Total of all reporting groups

Baseline Measures
    Placebo First, Then Neurotropin     Neurotropin First, Then Placebo     Total  
Number of Participants  
[units: participants]
  11     10     21  
Age  
[units: participants]
     
<=18 years     2     0     2  
Between 18 and 65 years     9     9     18  
>=65 years     0     1     1  
Age  
[units: years]
Mean (Standard Deviation)
  37.3  (13.2)     46.5  (13.2)     41.7  (13.7)  
Gender  
[units: participants]
     
Female     10     5     15  
Male     1     5     6  
Region of Enrollment  
[units: participants]
     
United States     11     10     21  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Visual Analogue Scale (VAS) of Pain Scores After Administration of Test Drugs (Placebo or Neurotropin )   [ Time Frame: VAS of each patient is measured after each 5-week treatment interval with placebo or Neurotropin. ]

2.  Primary:   Numeric Rating Scale (NRS) of Pain Scores After Administration of Test Drugs (Neurotropin or Placebo)   [ Time Frame: NRS of each patient is measured after each five-week treatment interval with placebo or Neurotropin. ]

3.  Primary:   McGill Pain Questionnaire (MPQ) of Scores After Administration of Test Drugs (Neurotropin or Placebo)   [ Time Frame: MPQ of each patient is measured after each five-week treatment interval with drug A or drug B. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: saliganl@mail.nih.gov


Publications:

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 )
Study First Received: September 21, 2000
Results First Received: June 4, 2013
Last Updated: May 12, 2016
Health Authority: United States: Food and Drug Administration