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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 4, 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

  Participant Flow

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

Reporting Groups
  Description
Study Drug A Then Study Drug B (G-1) 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.
Study Drug B First, Then Study Drug A (G-2) 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.

Participant Flow for 3 periods

Period 1:   First Phase: 12 Weeks
    Study Drug A Then Study Drug B (G-1)   Study Drug B First, Then Study Drug A (G-2)
STARTED   27   29 
COMPLETED   24   21 
NOT COMPLETED   3   8 
Adverse Event                1                3 
Withdrawal by Subject                2                5 

Period 2:   Washout Period (at Least a Week)
    Study Drug A Then Study Drug B (G-1)   Study Drug B First, Then Study Drug A (G-2)
STARTED   24   21 
COMPLETED   24   21 
NOT COMPLETED   0   0 

Period 3:   Second Phase: 12 Weeks
    Study Drug A Then Study Drug B (G-1)   Study Drug B First, Then Study Drug A (G-2)
STARTED   24   21 
COMPLETED   21   18 
NOT COMPLETED   3   3 
Adverse Event                1                1 
Withdrawal by Subject                2                2 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Placebo First, Then Neurotropin (G-1) 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.
Neurotropin First, Then Placebo (G-2) 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 Total of all reporting groups

Baseline Measures
   Placebo First, Then Neurotropin (G-1)   Neurotropin First, Then Placebo (G-2)   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   27   56 
Age 
[Units: Participants]
Count of Participants
     
<=18 years   0   0   0 
Between 18 and 65 years   27   27   54 
>=65 years   2   0   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.6  (12.6)   41.7  (12.9)   44.3  (12.8) 
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
     
Female   29   27   56 
Male   0   0   0 
[1] 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
United States   29   27   56 


  Outcome Measures

1.  Primary:   Fibromyalgia Impact Questionnaire   [ Time Frame: 25 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Leorey Saligan, Chief
Organization: Symptoms Biology Unit, DIR, NINR, NIH
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: NCT00366535     History of Changes
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 4, 2018