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| Name | Class |
|---|---|
| Stanford University | OTHER |
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We have found that low dose naltrexone (LDN) can substantially reduce pain associated with fibromyalgia syndrome. We believe LDN may work via novel anti-inflammatory channels. The purpose of this study is to determine if LDN lowers inflammatory markers in individuals with fibromyalgia.
Eligible women with Fibromyalgia (FM) will be enrolled into a 10-week drug trial. During the first two weeks, a baseline phase will be used to collect data on immune function and symptoms. LDN will be administered for 8 weeks. Although there is no placebo arm built-in, participants will be advised that they may receive a placebo during the trial. Participants will provide twice daily symptom reports using an android tablet device and Dooblo SurveyToGo survey software. Participants will also provide a blood sample twice every week for the duration of the study. Plasma inflammatory markers will be tested using a luminex based 63-plex inflammatory assay panel.
The primary aim of the study is to test if 8 weeks of LDN administration is associated with a reduction in pro-inflammatory markers in plasma in women with FM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose Naltrexone (LDN) | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose Naltrexone | Drug | Naltrexone 4.5 mg p.o. nocte |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in IL-1α From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. | |
| Change in IL-1β From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. | |
| Change in IL-1Ra From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. | |
| Change in IL-2 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. | |
| Change in IL-4 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. | |
| Change in IL-5 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. | |
| Change in IL-6 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. | |
| Change in IL-7 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. | |
| Change in IL-8 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. | |
| Change in IL-9 From Baseline. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jarred Younger, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Palo Alto | California | 94304 | United States |
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Participants were recruited Feb-April 2014 from a laboratory database of individuals with fibromyalgia who are interested in participating in research.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in IL-1α From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
8 week drug administration period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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No placebo control drug used - participants were only advised that placebo may be used during the trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jarred Younger | University of Alabama at Birmingham | 2059755821 | younger@uab.edu |
Not provided
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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Not provided
| ID | Term |
|---|---|
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in IL-10 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in IL-12p40 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in IL-12p70 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in IL-13 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in IL-15 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in IL-17A From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in IL-17F From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in IL-18 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in IL-21 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in IL-23 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in IL-31 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in IL-27 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in LIF From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in G-CSF From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in GM-CSF From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in MIP-1α From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in SDF-1α From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in IP-10 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in Eotaxin From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in RANTES From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in MIP-1β From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in MCP-1 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in MCP-3 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in MIG From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in TRAIL From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in CD40L From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in TGF-α From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in TGF-β From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in IFN-α From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in IFN-β From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in IFN-γ From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in TNF-α From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in TNF-β From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in PIGF-1 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in SCF From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in HGF From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in VEGF-D From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in VEGF From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in NGF From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in EGF From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in FGF-β From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in M-CSF From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in BDNF From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in ICAM-1 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in VCAM-1 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in ENA-78 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in PDGF-BB From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in PAI-1 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in Leptin From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in Resistin From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in GROa From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in FaSL From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in IL-22 From Baseline. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in Pain From Baseline. | 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. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| Change in Overall Fibromyalgia Symptoms From Baseline. | 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. | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Change in IL-1β From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in IL-1Ra From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in IL-2 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in IL-4 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in IL-5 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in IL-6 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in IL-7 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in IL-8 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
| Primary | Change in IL-9 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
| Primary | Change in IL-10 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in IL-12p40 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in IL-12p70 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in IL-13 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in IL-15 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in IL-17A From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in IL-17F From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in IL-18 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in IL-21 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in IL-23 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
| Primary | Change in IL-31 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
| Primary | Change in IL-27 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in LIF From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in G-CSF From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in GM-CSF From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in MIP-1α From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in SDF-1α From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in IP-10 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in Eotaxin From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in RANTES From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in MIP-1β From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in MCP-1 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in MCP-3 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in MIG From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in TRAIL From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in CD40L From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in TGF-α From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in TGF-β From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in IFN-α From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in IFN-β From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in IFN-γ From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in TNF-α From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in TNF-β From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
| Primary | Change in PIGF-1 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in SCF From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in HGF From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in VEGF-D From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in VEGF From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in NGF From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in EGF From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in FGF-β From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
| Primary | Change in M-CSF From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
| Primary | Change in BDNF From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in ICAM-1 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in VCAM-1 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in ENA-78 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in PDGF-BB From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in PAI-1 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in Leptin From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in Resistin From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in GROa From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
| Primary | Change in FaSL From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
| Primary | Change in IL-22 From Baseline. | Posted | Median | 95% Confidence Interval | pg/mL | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in Pain From Baseline. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| Primary | Change in Overall Fibromyalgia Symptoms From Baseline. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total]. |
|
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
Not provided
Not provided
Not provided
| D009422 |
| Nervous System Diseases |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |