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Neurotropin Treatment of Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00366535
Recruitment Status : Completed
First Posted : August 21, 2006
Results First Posted : June 4, 2018
Last Update Posted : June 27, 2018
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health Clinical Center (CC)
University of Michigan
National Cancer Institute (NCI)
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
Condition Fibromyalgia
Interventions Drug: Placebo
Drug: Neurotropin
Enrollment 56
Recruitment Details Most patients were recruited by direct physician referral or through the Patient Recruitment and Public Liaison (PRPL) office. Potential subjects were screened for study eligibility at the NIH Clinical Center.
Pre-assignment Details Patients with abnormal screening laboratory tests or had positive HIV test were excluded from study participation. Women who had positive urine pregnancy test were also excluded. Also patients with traumatic or non-traumatic pain disorders or had neurocognitive impairment making it challenging to obtain informed consent, were also excluded.
Arm/Group Title Study Drug A Then Study Drug B (G-1) Study Drug B First, Then Study Drug A (G-2)
Hide Arm/Group Description Double blind cross-over study: received Placebo (4 tabs, b.i.d.) for 12 weeks and then Neurotropin (4 tabs, b.i.d.) for 12 weeks (after at least 1 week washout period). Assignment to each group was randomized by the NIH Clinical Center pharmacy. Study team and participants were all blinded. Double blind cross-over study: received Study drug B (4 tabs, b.i.d.) for 12 weeks and then Study drug A (4 tabs, b.i.d.) for 12 weeks (after at least 1 week washout period). Assignment to each group was randomized by the NIH CC pharmacy. Study team and participants were blinded.
Period Title: First Phase: 12 Weeks
Started 27 29
Completed 24 21
Not Completed 3 8
Reason Not Completed
Adverse Event             1             3
Withdrawal by Subject             2             5
Period Title: Washout Period (at Least a Week)
Started 24 21
Completed 24 21
Not Completed 0 0
Period Title: Second Phase: 12 Weeks
Started 24 21
Completed 21 18
Not Completed 3 3
Reason Not Completed
Adverse Event             1             1
Withdrawal by Subject             2             2
Arm/Group Title Placebo First, Then Neurotropin (G-1) Neurotropin First, Then Placebo (G-2) Total
Hide Arm/Group Description Double blind cross-over study: receive Placebo (4 tabs, b.i.d.) for 12 weeks and then Neurotropin (4 tabs, b.i.d.) for 12 weeks (after at least 1 week washout period). Assignment to each group was in random order, selected by the pharmacy with all others blind. Double blind cross-over study: receive Neurotropin (4 tabs, b.i.d.) for 12 weeks and then Placebo (4 tabs, b.i.d.) for 12 weeks (after at least 1 week washout period). Assignment to each group was in random order, selected by the pharmacy with all others blind. Total of all reporting groups
Overall Number of Baseline Participants 29 27 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
<=18 years 0 0 0
Between 18 and 65 years 27 27 54
>=65 years 2 0 2
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 27 participants 56 participants
45.6  (12.6) 41.7  (12.9) 44.3  (12.8)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
Female 29 27 56
Male 0 0 0
[1]
Measure Description: Because fibromyalgia is much more common in women and because there are significant gender differences in the clinical characteristics of the disorder, only women will be included in the study.
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
American Indian or Alaska Native 0 0 0
Asian 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 2 5 7
White 27 20 47
More than one race 0 1 1
Unknown or Not Reported 0 1 1
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 29 participants 27 participants 56 participants
29 27 56
1.Primary Outcome
Title Fibromyalgia Impact Questionnaire
Hide Description The Fibromyalgia Impact Questionnaire (FIQ) is a brief 10-item self-administered measure to assess 3 areas of fibromyalgia (FM): function, overall impact, and symptoms. The total FIQ score was the primary outcome of the study. The total FIQ score is the sum of the 3 areas measured in the FIQ. The maximum possible total FIQ score is 100, with a minimum score of 10. The average FM patient scores about 50, severely afflicted FM patients are usually 70 and above. Data analysis is ongoing from data collected from study completers.
Time Frame 25 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Total 56 patients enrolled, and 39 patients completed the study. 17 patients withdrawn from the study. Three of 39 patients were excluded from the data analysis because there had missing FIQ scores at Baseline and/or Week 12. The data from the study of the 36 participants with complete data sets was analyzed.
Arm/Group Title FIQ Before Placebo Treatment First in G-1 FIQ After Placebo Treatment First in G-1 FIQ Before Neurotropin Treatment Second in G-1 FIQ After Neurotropin Treatment Second in G-1 FIQ Before Neurotropin Treatment First in G-2 FIQ After Neurotropin Treatment First in G-2 FIQ Before Placebo Treatment Second in G-2 FIQ After Placebo Treatment Second in G-2
Hide Arm/Group Description:
FIQ of this group was determined before the 12 week-treatment with Placebo.
This group received Placebo 4 tabs b.i.d. for 12 weeks first. FIQ was determined at the end of the 12 week-treatment with Placebo.
FIQ of this group was determined before the 12 week-treatment with Neurotropin.
This group received Neurotropin 4 tabs b.i.d. for 12 weeks after at least 1 week "washout" period following the first 12 week interval on placebo. FIQ was determined at the end of the 12 week-treatment with Neurotropin.
FIQ of this group was determined before the 12 week-treatment with Neurotropin.
This group received Neurotropin 4 tabs b.i.d. for 12 weeks first. FIQ was determined at the end of the 12 week-treatment with Placebo.
FIQ of this group was determined before the 12 week-treatment with Placebo.
This group received Placebo 4 tabs b.i.d. for 12 weeks after at least 1 week "washout" period following the first 12 week interval on placebo. FIQ was determined at the end of the 12 week-treatment with Placebo.
Overall Number of Participants Analyzed 20 20 20 20 16 16 16 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
49.9  (1.8) 37.5  (3.7) 39.9  (3.4) 33.4  (4.1) 47.7  (2.1) 28.8  (4.5) 30.1  (4.1) 32.8  (3.6)
Time Frame The adverse event data was collected during the study period for 6 to 7 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Treatment First in G-1 Neurotropin Treatment Second in G-1 Neurotropin Treatment First in G-2 Placebo Treatment Second in G-2
Hide Arm/Group Description This group received Placebo 4 tabs b.i.d. for the first 12 weeks. This group received Neurotropin 4 tabs b.i.d. for 12 weeks after at least 1 week "washout" period following the first 12 week interval on Placebo. This group received Neurotropin 4 tabs b.i.d. for the first 12 weeks. This group received Placebo 4 tabs b.i.d. for 12 weeks after at least 1 week "washout" period following the first 12 week interval on Neurotropin.
All-Cause Mortality
Placebo Treatment First in G-1 Neurotropin Treatment Second in G-1 Neurotropin Treatment First in G-2 Placebo Treatment Second in G-2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)      0/29 (0.00%)      0/27 (0.00%)      0/27 (0.00%)    
Hide Serious Adverse Events
Placebo Treatment First in G-1 Neurotropin Treatment Second in G-1 Neurotropin Treatment First in G-2 Placebo Treatment Second in G-2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/56 (0.00%)      0/29 (0.00%)      0/27 (0.00%)      0/27 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Treatment First in G-1 Neurotropin Treatment Second in G-1 Neurotropin Treatment First in G-2 Placebo Treatment Second in G-2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/56 (5.36%)      1/29 (3.45%)      3/27 (11.11%)      1/27 (3.70%)    
Cardiac disorders         
Chest pain and Abnormal HB * [1]  1/56 (1.79%)  1 0/29 (0.00%)  0 2/27 (7.41%)  2 0/27 (0.00%)  0
Hepatobiliary disorders         
Abnormality of liver function test * [2]  1/56 (1.79%)  1 0/29 (0.00%)  0 0/27 (0.00%)  0 0/27 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Pain * [3]  1/56 (1.79%)  1 1/29 (3.45%)  1 0/27 (0.00%)  0 1/27 (3.70%)  1
Nervous system disorders         
Dizziness * [4]  0/56 (0.00%)  0 0/29 (0.00%)  0 1/27 (3.70%)  1 0/27 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Chest pain followed by dizziness, shortness of breath and weakness, abnormal heart beat
[2]
Increased in plasma levels of ALT, AST and LDH, and creatinine kinase
[3]
Increased of pain
[4]
Caused dizziness, headache and difficulty walking
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Leorey Saligan, Chief
Organization: Symptoms Biology Unit, DIR, NINR, NIH
Phone: 301-451-1685
EMail: saliganl@mail.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )
ClinicalTrials.gov Identifier: NCT00366535    
Other Study ID Numbers: 060229
06-NR-0229 ( Other Identifier: NIH )
First Submitted: August 18, 2006
First Posted: August 21, 2006
Results First Submitted: August 21, 2017
Results First Posted: June 4, 2018
Last Update Posted: June 27, 2018