Trial Outcomes & Findings for Neurotropin Treatment of Fibromyalgia (NCT NCT00366535)
NCT ID: NCT00366535
Last Updated: 2018-06-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
25 weeks
Results posted on
2018-06-27
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
First Phase: 12 Weeks
STARTED
|
27
|
29
|
|
First Phase: 12 Weeks
COMPLETED
|
24
|
21
|
|
First Phase: 12 Weeks
NOT COMPLETED
|
3
|
8
|
|
Washout Period (at Least a Week)
STARTED
|
24
|
21
|
|
Washout Period (at Least a Week)
COMPLETED
|
24
|
21
|
|
Washout Period (at Least a Week)
NOT COMPLETED
|
0
|
0
|
|
Second Phase: 12 Weeks
STARTED
|
24
|
21
|
|
Second Phase: 12 Weeks
COMPLETED
|
21
|
18
|
|
Second Phase: 12 Weeks
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
First Phase: 12 Weeks
Adverse Event
|
1
|
3
|
|
First Phase: 12 Weeks
Withdrawal by Subject
|
2
|
5
|
|
Second Phase: 12 Weeks
Adverse Event
|
1
|
1
|
|
Second Phase: 12 Weeks
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Neurotropin Treatment of Fibromyalgia
Baseline characteristics by cohort
| Measure |
Placebo First, Then Neurotropin (G-1)
n=29 Participants
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)
n=27 Participants
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
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
45.6 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
41.7 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
44.3 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 25 weeksPopulation: 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.
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.
Outcome measures
| Measure |
FIQ Before Placebo Treatment First in G-1
n=20 Participants
FIQ of this group was determined before the 12 week-treatment with Placebo.
|
FIQ After Placebo Treatment First in G-1
n=20 Participants
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 Before Neurotropin Treatment Second in G-1
n=20 Participants
FIQ of this group was determined before the 12 week-treatment with Neurotropin.
|
FIQ After Neurotropin Treatment Second in G-1
n=20 Participants
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 Before Neurotropin Treatment First in G-2
n=16 Participants
FIQ of this group was determined before the 12 week-treatment with Neurotropin.
|
FIQ After Neurotropin Treatment First in G-2
n=16 Participants
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 Before Placebo Treatment Second in G-2
n=16 Participants
FIQ of this group was determined before the 12 week-treatment with Placebo.
|
FIQ After Placebo Treatment Second in G-2
n=16 Participants
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.
|
|---|---|---|---|---|---|---|---|---|
|
Fibromyalgia Impact Questionnaire
|
49.9 units on a scale
Standard Deviation 1.8
|
37.5 units on a scale
Standard Deviation 3.7
|
39.9 units on a scale
Standard Deviation 3.4
|
33.4 units on a scale
Standard Deviation 4.1
|
47.7 units on a scale
Standard Deviation 2.1
|
28.8 units on a scale
Standard Deviation 4.5
|
30.1 units on a scale
Standard Deviation 4.1
|
32.8 units on a scale
Standard Deviation 3.6
|
Adverse Events
Placebo Treatment First in G-1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Neurotropin Treatment Second in G-1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Neurotropin Treatment First in G-2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Treatment Second in G-2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Treatment First in G-1
n=56 participants at risk
This group received Placebo 4 tabs b.i.d. for the first 12 weeks.
|
Neurotropin Treatment Second in G-1
n=29 participants at risk
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.
|
Neurotropin Treatment First in G-2
n=27 participants at risk
This group received Neurotropin 4 tabs b.i.d. for the first 12 weeks.
|
Placebo Treatment Second in G-2
n=27 participants at risk
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.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Abnormality of liver function test
|
1.8%
1/56 • Number of events 1 • The adverse event data was collected during the study period for 6 to 7 months.
|
0.00%
0/29 • The adverse event data was collected during the study period for 6 to 7 months.
|
0.00%
0/27 • The adverse event data was collected during the study period for 6 to 7 months.
|
0.00%
0/27 • The adverse event data was collected during the study period for 6 to 7 months.
|
|
Cardiac disorders
Chest pain and Abnormal HB
|
1.8%
1/56 • Number of events 1 • The adverse event data was collected during the study period for 6 to 7 months.
|
0.00%
0/29 • The adverse event data was collected during the study period for 6 to 7 months.
|
7.4%
2/27 • Number of events 2 • The adverse event data was collected during the study period for 6 to 7 months.
|
0.00%
0/27 • The adverse event data was collected during the study period for 6 to 7 months.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
1.8%
1/56 • Number of events 1 • The adverse event data was collected during the study period for 6 to 7 months.
|
3.4%
1/29 • Number of events 1 • The adverse event data was collected during the study period for 6 to 7 months.
|
0.00%
0/27 • The adverse event data was collected during the study period for 6 to 7 months.
|
3.7%
1/27 • Number of events 1 • The adverse event data was collected during the study period for 6 to 7 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/56 • The adverse event data was collected during the study period for 6 to 7 months.
|
0.00%
0/29 • The adverse event data was collected during the study period for 6 to 7 months.
|
3.7%
1/27 • Number of events 1 • The adverse event data was collected during the study period for 6 to 7 months.
|
0.00%
0/27 • The adverse event data was collected during the study period for 6 to 7 months.
|
Additional Information
Leorey Saligan, Chief
Symptoms Biology Unit, DIR, NINR, NIH
Phone: 301-451-1685
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place