Trial Outcomes & Findings for Low Dose Naltrexone (LDN) Immune Monitoring (NCT NCT02107014)
NCT ID: NCT02107014
Last Updated: 2017-04-11
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].
Results posted on
2017-04-11
Participant Flow
Participants were recruited Feb-April 2014 from a laboratory database of individuals with fibromyalgia who are interested in participating in research.
Participant milestones
| Measure |
Low Dose Naltrexone (LDN)
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Low Dose Naltrexone (LDN)
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Overall Study
Withdrew before drug: moving interstate
|
1
|
Baseline Characteristics
Low Dose Naltrexone (LDN) Immune Monitoring
Baseline characteristics by cohort
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-1α From Baseline.
IL-1α baseline 2-weeks
|
3.56 pg/mL
Interval 3.52 to 4.43
|
|
Change in IL-1α From Baseline.
IL-1α last 2-weeks
|
3.88 pg/mL
Interval 3.79 to 4.74
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-1β From Baseline.
IL-1β baseline 2-weeks
|
0.33 pg/mL
Interval 0.16 to 14.98
|
|
Change in IL-1β From Baseline.
IL-1β last 2-weeks
|
0.26 pg/mL
Interval 0.04 to 10.88
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-1Ra From Baseline.
IL-1Ra baseline 2-weeks
|
2433.11 pg/mL
Interval 2406.25 to 2500.26
|
|
Change in IL-1Ra From Baseline.
IL-1Ra last 2-weeks
|
2004.48 pg/mL
Interval 1846.09 to 2164.39
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-2 From Baseline.
IL-2 baseline 2-weeks
|
23.21 pg/mL
Interval 4.98 to 105.98
|
|
Change in IL-2 From Baseline.
IL-2 last 2-weeks
|
21.32 pg/mL
Interval 4.98 to 83.43
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-4 From Baseline.
IL-4 baseline 2-weeks
|
20.70 pg/mL
Interval 14.63 to 100.5
|
|
Change in IL-4 From Baseline.
IL-4 last 2-weeks
|
19.00 pg/mL
Interval 13.1 to 83.48
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-5 From Baseline.
IL-5 baseline 2-weeks
|
1.94 pg/mL
Interval 1.33 to 18.46
|
|
Change in IL-5 From Baseline.
IL-5 last 2-weeks
|
4.57 pg/mL
Interval 1.24 to 11.28
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-6 From Baseline.
IL-6 baseline 2-weeks
|
10.22 pg/mL
Interval 9.46 to 27.85
|
|
Change in IL-6 From Baseline.
IL-6 last 2-weeks
|
5.87 pg/mL
Interval 3.64 to 23.27
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-7 From Baseline.
IL-7 baseline 2-weeks
|
10.18 pg/mL
Interval 9.31 to 16.34
|
|
Change in IL-7 From Baseline.
IL-7 last 2-weeks
|
10.28 pg/mL
Interval 8.31 to 14.99
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-8 From Baseline.
IL-8 baseline 2-weeks
|
0 pg/mL
Interval 0.0 to 0.0
|
|
Change in IL-8 From Baseline.
IL-8 last 2-weeks
|
0 pg/mL
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-9 From Baseline.
IL-9 baseline 2-weeks
|
0 pg/mL
Interval 0.0 to 0.0
|
|
Change in IL-9 From Baseline.
IL-9 last 2-weeks
|
0 pg/mL
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-10 From Baseline.
IL-10 baseline 2-weeks
|
6.01 pg/mL
Interval 5.26 to 67.43
|
|
Change in IL-10 From Baseline.
IL-10 last 2-weeks
|
10.11 pg/mL
Interval 6.35 to 52.87
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-12p40 From Baseline.
IL-12p40 baseline 2-weeks
|
6.91 pg/mL
Interval 4.74 to 11.12
|
|
Change in IL-12p40 From Baseline.
IL-12p40 last 2-weeks
|
6.43 pg/mL
Interval 5.09 to 9.76
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-12p70 From Baseline.
IL-12p70 baseline 2-weeks
|
1.82 pg/mL
Interval 1.68 to 6.28
|
|
Change in IL-12p70 From Baseline.
IL-12p70 last 2-weeks
|
1.69 pg/mL
Interval 1.6 to 5.47
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-13 From Baseline.
IL-13 baseline 2-weeks
|
0.66 pg/mL
Interval 0.16 to 8.58
|
|
Change in IL-13 From Baseline.
IL-13 last 2-weeks
|
0.66 pg/mL
Interval 0.31 to 7.21
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-15 From Baseline.
IL-15 baseline 2-weeks
|
11.08 pg/mL
Interval 7.07 to 119.95
|
|
Change in IL-15 From Baseline.
IL-15 last 2-weeks
|
8.71 pg/mL
Interval 7.07 to 105.88
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-17A From Baseline.
IL-17A baseline 2-weeks
|
5.03 pg/mL
Interval 3.05 to 26.86
|
|
Change in IL-17A From Baseline.
IL-17A last 2-weeks
|
3.40 pg/mL
Interval 2.05 to 24.02
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-17F From Baseline.
IL-17F baseline 2-weeks
|
0.95 pg/mL
Interval 0.8 to 12.02
|
|
Change in IL-17F From Baseline.
IL-17F last 2-weeks
|
0.89 pg/mL
Interval 0.82 to 10.36
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-18 From Baseline.
IL-18 baseline 2-weeks
|
9.61 pg/mL
Interval 3.23 to 15.71
|
|
Change in IL-18 From Baseline.
IL-18 last 2-weeks
|
6.66 pg/mL
Interval 2.99 to 13.61
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-21 From Baseline.
IL-21 baseline 2-weeks
|
29.96 pg/mL
Interval 13.5 to 725.93
|
|
Change in IL-21 From Baseline.
IL-21 last 2-weeks
|
327.07 pg/mL
Interval 27.3 to 644.85
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-23 From Baseline.
IL-23 baseline 2-weeks
|
0 pg/mL
Interval 0.0 to 0.0
|
|
Change in IL-23 From Baseline.
IL-23 last 2-weeks
|
0 pg/mL
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-31 From Baseline.
IL-31 baseline 2-weeks
|
0 pg/mL
Interval 0.0 to 0.0
|
|
Change in IL-31 From Baseline.
IL-31 last 2-weeks
|
0 pg/mL
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-27 From Baseline.
IL-27 baseline 2-weeks
|
86.51 pg/mL
Interval 35.49 to 156.03
|
|
Change in IL-27 From Baseline.
IL-27 last 2-weeks
|
96.39 pg/mL
Interval 74.66 to 126.15
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in LIF From Baseline.
LIF baseline 2-weeks
|
4.93 pg/mL
Interval 3.98 to 87.52
|
|
Change in LIF From Baseline.
LIF last 2-weeks
|
4.49 pg/mL
Interval 4.19 to 84.25
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in G-CSF From Baseline.
G-CSF baseline 2-weeks
|
37.78 pg/mL
Interval 22.63 to 152.62
|
|
Change in G-CSF From Baseline.
G-CSF last 2-weeks
|
35.67 pg/mL
Interval 23.26 to 146.67
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in GM-CSF From Baseline.
GM-CSF baseline 2-weeks
|
5779.44 pg/mL
Interval 3252.62 to 26170.25
|
|
Change in GM-CSF From Baseline.
GM-CSF last 2-weeks
|
6377.62 pg/mL
Interval 2456.04 to 29829.31
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in MIP-1α From Baseline.
MIP-1α baseline 2-weeks
|
5.66 pg/mL
Interval 2.85 to 63.75
|
|
Change in MIP-1α From Baseline.
MIP-1α last 2-weeks
|
3.60 pg/mL
Interval 2.33 to 56.1
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in SDF-1α From Baseline.
SDF-1α baseline 2-weeks
|
148.14 pg/mL
Interval 95.03 to 1886.42
|
|
Change in SDF-1α From Baseline.
SDF-1α last 2-weeks
|
123.19 pg/mL
Interval 98.62 to 1955.32
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IP-10 From Baseline.
IP-10 baseline 2-weeks
|
6.01 pg/mL
Interval 4.59 to 8.5
|
|
Change in IP-10 From Baseline.
IP-10 last 2-weeks
|
5.28 pg/mL
Interval 4.73 to 8.44
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in Eotaxin From Baseline.
eotaxin baseline 2-weeks
|
36.54 pg/mL
Interval 19.41 to 78.23
|
|
Change in Eotaxin From Baseline.
eotaxin last 2-weeks
|
29.95 pg/mL
Interval 22.0 to 80.96
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in RANTES From Baseline.
RANTES baseline 2-weeks
|
57.00 pg/mL
Interval 49.04 to 105.46
|
|
Change in RANTES From Baseline.
RANTES last 2-weeks
|
57.27 pg/mL
Interval 47.15 to 123.27
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in MIP-1β From Baseline.
MIP-1β baseline 2-weeks
|
58.52 pg/mL
Interval 18.91 to 288.14
|
|
Change in MIP-1β From Baseline.
MIP-1β last 2-weeks
|
51.08 pg/mL
Interval 35.79 to 272.44
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in MCP-1 From Baseline.
MCP-1 baseline 2-weeks
|
24.30 pg/mL
Interval 15.25 to 87.01
|
|
Change in MCP-1 From Baseline.
MCP-1 last 2-weeks
|
25.38 pg/mL
Interval 19.6 to 74.88
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in MCP-3 From Baseline.
MCP-3 baseline 2-weeks
|
31.52 pg/mL
Interval 22.67 to 80.02
|
|
Change in MCP-3 From Baseline.
MCP-3 last 2-weeks
|
25.30 pg/mL
Interval 17.96 to 81.0
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in MIG From Baseline.
MIG baseline 2-weeks
|
47.81 pg/mL
Interval 28.8 to 1480.33
|
|
Change in MIG From Baseline.
MIG last 2-weeks
|
35.98 pg/mL
Interval 27.73 to 1520.4
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in TRAIL From Baseline.
TRAIL baseline 2-weeks
|
23.42 pg/mL
Interval 5.41 to 925.52
|
|
Change in TRAIL From Baseline.
TRAIL last 2-weeks
|
12.95 pg/mL
Interval 7.42 to 975.7
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in CD40L From Baseline.
CD40L baseline 2-weeks
|
41.97 pg/mL
Interval 30.11 to 316.03
|
|
Change in CD40L From Baseline.
CD40L last 2-weeks
|
35.78 pg/mL
Interval 19.5 to 281.48
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in TGF-α From Baseline.
TGF-α baseline 2-weeks
|
1.42 pg/mL
Interval 0.53 to 2.75
|
|
Change in TGF-α From Baseline.
TGF-α last 2-weeks
|
0.58 pg/mL
Interval 0.18 to 2.69
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in TGF-β From Baseline.
TGF-β baseline 2-weeks
|
9.40 pg/mL
Interval 7.03 to 159.01
|
|
Change in TGF-β From Baseline.
TGF-β last 2-weeks
|
7.80 pg/mL
Interval 6.05 to 141.56
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IFN-α From Baseline.
IFN-α baseline 2-weeks
|
4.99 pg/mL
Interval 3.19 to 16.76
|
|
Change in IFN-α From Baseline.
IFN-α last 2-weeks
|
4.15 pg/mL
Interval 3.57 to 14.49
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IFN-β From Baseline.
IFN-β baseline 2-weeks
|
24.04 pg/mL
Interval 14.07 to 215.46
|
|
Change in IFN-β From Baseline.
IFN-β last 2-weeks
|
19.10 pg/mL
Interval 15.81 to 179.89
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IFN-γ From Baseline.
IFN-γ baseline 2-weeks
|
11.42 pg/mL
Interval 5.99 to 31.35
|
|
Change in IFN-γ From Baseline.
IFN-γ last 2-weeks
|
9.29 pg/mL
Interval 7.18 to 25.99
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in TNF-α From Baseline.
TNF-α baseline 2-weeks
|
124.36 pg/mL
Interval 90.05 to 368.04
|
|
Change in TNF-α From Baseline.
TNF-α last 2-weeks
|
116.04 pg/mL
Interval 89.75 to 339.64
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in TNF-β From Baseline.
TNF-β baseline 2-weeks
|
0 pg/mL
Interval 0.0 to 0.0
|
|
Change in TNF-β From Baseline.
TNF-β last 2-weeks
|
0 pg/mL
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in PIGF-1 From Baseline.
PIGF-1 baseline 2-weeks
|
1.75 pg/mL
Interval 1.65 to 2.46
|
|
Change in PIGF-1 From Baseline.
PIGF-1 last 2-weeks
|
2.09 pg/mL
Interval 1.98 to 2.4
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in SCF From Baseline.
SCF baseline 2-weeks
|
7.53 pg/mL
Interval 3.05 to 66.74
|
|
Change in SCF From Baseline.
SCF last 2-weeks
|
5.41 pg/mL
Interval 2.21 to 65.39
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in HGF From Baseline.
HGF baseline 2-weeks
|
187.27 pg/mL
Interval 150.29 to 1627.38
|
|
Change in HGF From Baseline.
HGF last 2-weeks
|
189.33 pg/mL
Interval 130.54 to 1582.27
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in VEGF-D From Baseline.
VEGF-D baseline 2-weeks
|
2.62 pg/mL
Interval 0.43 to 55.26
|
|
Change in VEGF-D From Baseline.
VEGF-D last 2-weeks
|
3.30 pg/mL
Interval 0.81 to 56.61
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in VEGF From Baseline.
VEGF baseline 2-weeks
|
80.95 pg/mL
Interval 29.94 to 710.36
|
|
Change in VEGF From Baseline.
VEGF last 2-weeks
|
70.70 pg/mL
Interval 33.64 to 689.66
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in NGF From Baseline.
NGF baseline 2-weeks
|
12.24 pg/mL
Interval 4.32 to 150.09
|
|
Change in NGF From Baseline.
NGF last 2-weeks
|
10.50 pg/mL
Interval 1.88 to 139.01
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in EGF From Baseline.
EGF baseline 2-weeks
|
5.23 pg/mL
Interval 1.77 to 97.32
|
|
Change in EGF From Baseline.
EGF last 2-weeks
|
3.23 pg/mL
Interval 0.35 to 41.64
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in FGF-β From Baseline.
FGF-β baseline 2-weeks
|
0 pg/mL
Interval 0.0 to 0.0
|
|
Change in FGF-β From Baseline.
FGF-β last 2-weeks
|
0 pg/mL
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in M-CSF From Baseline.
M-CSF baseline 2-weeks
|
0 pg/mL
Interval 0.0 to 0.0
|
|
Change in M-CSF From Baseline.
M-CSF last 2-weeks
|
0 pg/mL
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in BDNF From Baseline.
BDNF baseline 2-weeks
|
777.60 pg/mL
Interval 478.46 to 1687.16
|
|
Change in BDNF From Baseline.
BDNF last 2-weeks
|
717.98 pg/mL
Interval 399.81 to 1824.11
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in ICAM-1 From Baseline.
ICAM-1 last 2-weeks
|
2820.63 pg/mL
Interval 1569.72 to 3802.24
|
|
Change in ICAM-1 From Baseline.
ICAM-1 baseline 2-weeks
|
2670.81 pg/mL
Interval 1368.85 to 4326.96
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in VCAM-1 From Baseline.
VCAM-1 baseline 2-weeks
|
30876.40 pg/mL
Interval 28221.23 to 54690.42
|
|
Change in VCAM-1 From Baseline.
VCAM-1 last 2-weeks
|
32156.99 pg/mL
Interval 26838.15 to 70652.26
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in ENA-78 From Baseline.
ENA-78 baseline 2-weeks
|
134.64 pg/mL
Interval 20.4 to 226.86
|
|
Change in ENA-78 From Baseline.
ENA-78 last 2-weeks
|
83.36 pg/mL
Interval 16.32 to 197.58
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in PDGF-BB From Baseline.
PDGF-BB baseline 2-weeks
|
179.89 pg/mL
Interval 129.46 to 269.13
|
|
Change in PDGF-BB From Baseline.
PDGF-BB last 2-weeks
|
150.29 pg/mL
Interval 122.19 to 305.54
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in PAI-1 From Baseline.
PAI-1 baseline 2-weeks
|
15086.40 pg/mL
Interval 13707.57 to 23919.29
|
|
Change in PAI-1 From Baseline.
PAI-1 last 2-weeks
|
15536.99 pg/mL
Interval 14295.96 to 29989.92
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in Leptin From Baseline.
leptin baseline 2-weeks
|
3991.44 pg/mL
Interval 1950.32 to 8616.49
|
|
Change in Leptin From Baseline.
leptin last 2-weeks
|
4128.32 pg/mL
Interval 1762.54 to 9120.73
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in Resistin From Baseline.
Resistin baseline 2-weeks
|
1831.26 pg/mL
Interval 1504.34 to 2771.75
|
|
Change in Resistin From Baseline.
Resistin last 2-weeks
|
1942.47 pg/mL
Interval 1722.55 to 3009.37
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in GROa From Baseline.
GROa baseline 2-weeks
|
0 pg/mL
Interval 0.0 to 0.0
|
|
Change in GROa From Baseline.
GROa last 2-weeks
|
0 pg/mL
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in FaSL From Baseline.
FaSL baseline 2-weeks
|
0 pg/mL
Interval 0.0 to 0.0
|
|
Change in FaSL From Baseline.
FaSL last 2-weeks
|
0 pg/mL
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in IL-22 From Baseline.
IL-22 baseline 2-weeks
|
194.59 pg/mL
Interval 99.61 to 1193.8
|
|
Change in IL-22 From Baseline.
IL-22 last 2-weeks
|
220.62 pg/mL
Interval 132.15 to 1012.5
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Visual analog scale (0-100) anchored at "no pain" at 0 and "worst possible pain" at 100. Improvement in pain would be indicated by a decrease in the score.
Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in Pain From Baseline.
Pain last 2-weeks
|
43.286 units on a scale
Standard Error 4.805
|
|
Change in Pain From Baseline.
Pain baseline 2-weeks
|
51.149 units on a scale
Standard Error 4.841
|
PRIMARY outcome
Timeframe: Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].Visual analog scale (0-100) anchored at "no symptoms" at 0 and "worst possible symptoms" at 100. Improvement in overall fibromyalgia symptoms would be indicated by a decrease in the score.
Outcome measures
| Measure |
Low Dose Naltrexone (LDN)
n=8 Participants
Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.
Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte
|
|---|---|
|
Change in Overall Fibromyalgia Symptoms From Baseline.
Overall symptoms baseline 2-weeks
|
55.653 units on a scale
Standard Error 4.671
|
|
Change in Overall Fibromyalgia Symptoms From Baseline.
Overall symptoms last 2-weeks
|
45.506 units on a scale
Standard Error 4.633
|
Adverse Events
Low Dose Naltrexone (LDN)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place