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Evaluation of the effect of combinatorial treatment of fibromyalgia patients (standard of care + minocycline + N-acetylcysteine (NAC) relative to standard of care on subjective pain measurement Revised Fibromyalgia Impact Questionnaire (FIQR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo followed by minocycline (200 mg daily) and NAC (1200 mg daily) | Active Comparator | Participants will be randomized to 8 weeks of placebo, minimum 2 week washout period, and then 8 weeks of a combination minocycline (200 mg daily) and NAC (1200 mg daily) followed by a final 2 week washout |
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| minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo | Active Comparator | Participants will be randomized to 8 weeks of a combination minocycline (200 mg daily) and NAC (1200 mg daily), minimum 2 week washout period, and then 8 weeks of placebo followed by a final 2 week washout |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo | Drug | minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Revised Fibromyalgia Impact Questionnaire (FIQR) Score From Baseline to After Treatment Occurring at Weeks 8 and 18 | The FIQR (Revised Fibromyalgia Impact Questionnaire) is comprised of 21 questions spread across 3 domains: function, overall impact, symptoms, scored on an 11-point numeric rating scale. The questions are framed with the context of the past 7 days. The instructions ask the patient to rate the difficulty on a scale of 0-10 (0 = No difficulty, and 10 = Very difficult) which indicates how much difficulty they have experienced in doing the specified activity during the past 7 days. Each item is rated on a scale from 0 - 10, and the raw scores on each subscale. Then, the score on the function subscale is divided by 3, the overall impact subscale divided by 1, and the symptoms subscale divided by 2. These final scores from each subscale are then added up for the total FIQR score The total score can range from 0 -100. The total FIQR score is the sum of each section. A lower score means a better outcome. Higher scores indicate more severe impact. | Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain, Enjoyment of Life and General Activity (PEG) Scale From Baseline to After Treatment Occurring at Weeks 8 and 18 | In the PEG score, a higher score indicates more severe pain and pain-related interference. The PEG has 3 separate numerical scales. Each has ratings 0-10.The first scale asks individuals to rate their pain, on average, over the past week, the second asks to rate how pain has interfered with their enjoyment of life in the past week, the third asks individuals to rate how pain has interfered with general activities. The PEG scale is scored by averaging the three numbers. The final score helps to track and monitor pain levels over time. The PEG score should decrease when treatment is effective. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia (Modified ACR 2010) | Participants will rate change using modified 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia (modified ACR 2010) by answering questions related to their areas of pain, amount of medication required for pain, and symptoms. | Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 18 |
Inclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Michael G Hillegass, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Followed by Minocycline (200 mg Daily) and NAC (1200 mg Daily) | Participants will be randomized to 8 weeks of placebo, minimum 2 week washout period, and then 8 weeks of a combination minocycline (200 mg daily) and NAC (1200 mg daily) followed by a final 2 week washout Placebo followed by minocycline (200 mg daily) and NAC (1200 mg daily): Placebo followed by minocycline (200 mg daily) and NAC (1200 mg daily) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention (8 Weeks) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 2, 2021 |
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• A simple randomization method will be used to assign the initial treatment and then the opposite treatment will ensure for the second treatment period. Patients will be randomized to (i) 8 weeks of placebo, minimum 2 week washout period, and then 8 weeks of a combination minocycline (200 mg daily) and NAC (1200 mg daily) followed by a final 2 week washout or (ii) 8 weeks of a combination minocycline (200 mg daily) and NAC (1200 mg daily), minimum 2 week washout period, and then 8 weeks of placebo followed by a final 2 week washout.
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| Placebo followed by minocycline (200 mg daily) and NAC (1200 mg daily) | Drug | Placebo followed by minocycline (200 mg daily) and NAC (1200 mg daily) |
|
| Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 18 |
| Change in Patient Health Questionnaire (PHQ-2) From Baseline to After Treatment Occurring at Weeks 8 and 18 | The change in depression scale (PHQ-2) by evaluating the number of days the participant feels down, depressed or hopeless and has little interest or pleasure in doing things rated as not at all (0), several days (1), more than half the days (2), or nearly every day (3) by scoring the 2 questions from 0-3 as indicated. Scores range from 0-6, with the higher score meaning the patient experiencing more severe symptoms. | Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 18 |
| Change in General Anxiety Disorder (GAD-2) Score From Baseline to After Treatment Occurring at Weeks 8 and 18 | The Generalized Anxiety Disorder 2-item (GAD-2) screens for generalized anxiety disorder 1. Two questions are asked, with the scoring of each ranging from 0-3, then both numbers added together, with possible scores ranging from 0-6. A total score of at least 3 points indicates possible anxiety disorder. The higher the score, the more severe anxiety. | Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 18 |
| Patient Global Impression of Change (PGIC) | Patient Global Impression of Change (PGIC) has the subject will reporting whether there was a change in their activity, limitations, symptoms, emotions and overall quality of life by rating "no change", "almost the same", "a little better", "somewhat better", "moderately better", "better" or "a great deal better". Participants will also rate degrees of change from much better (0), 5 (no change), to much worse (10). The higher the score, the worse their impression of their health status was worse than previously. Scores will range from no change to a great deal better, and from 0 (much better) to 10 (much worse). | immediately after each treatment at week 8 (first intervention) and week 18 (second intervention) |
| FG001 | Minocycline (200 mg Daily) and NAC (1200 mg Daily) Followed by Placebo | Participants will be randomized to 8 weeks of a combination minocycline (200 mg daily) and NAC (1200 mg daily), minimum 2 week washout period, and then 8 weeks of placebo followed by a final 2 week washout minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo: minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo |
| Received Intervention |
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| COMPLETED |
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| NOT COMPLETED |
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| First Washout (2 Weeks) |
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| Second Intervention (8 Weeks) |
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| Second Washout (2 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Followed by Minocycline (200 mg Daily) and NAC (1200 mg Daily) | Participants will be randomized to 8 weeks of placebo, minimum 2 week washout period, and then 8 weeks of a combination minocycline (200 mg daily) and NAC (1200 mg daily) followed by a final 2 week washout Placebo followed by minocycline (200 mg daily) and NAC (1200 mg daily): Placebo followed by minocycline (200 mg daily) and NAC (1200 mg daily) |
| BG001 | Minocycline (200 mg Daily) and NAC (1200 mg Daily) Followed by Placebo | Participants will be randomized to 8 weeks of a combination minocycline (200 mg daily) and NAC (1200 mg daily), minimum 2 week washout period, and then 8 weeks of placebo followed by a final 2 week washout minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo: minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Duration of Formal Diagnosis | Number | participants |
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| Duration of Symptoms | Number | participants |
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| Fibromyalgia Impact Questionnaire (FIQR) Score | The FIQR (Revised Fibromyalgia Impact Questionnaire) is comprised of 21 questions; 3 domains = function, overall impact, symptoms; 11-point numeric rating scale; questions framed with the context of the past 7 days. The instructions ask the patient to rate the difficulty on a scale of 0-10 (0 = No difficulty, and 10 = Very difficult) which indicates how much difficulty they have experienced in doing this activity during the past 7 days. The total FIQR score is the sum of each section. Range of scores are from 0-100. A lower score means a better outcome. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| The Pain, Enjoyment of Life and General Activity (PEG) Score | In the PEG score, a higher score indicates more severe pain and pain-related interference. The PEG has 3 separate numerical scales. Each has ratings 0-10.The 1st scale asks individuals to rate their pain on average over the past week, the 2nd asks to rate how pain has interfered with their enjoyment of life in the past week, the 3rd asks to rate how pain has interfered with general activities. The total PEG scale is scored by adding each score and dividing by 3. The final score helps to track and monitor pain levels over time. The PEG score should decrease when treatment is effective. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Patient Health Questionnaire-2 (PHQ-2) Score | The PHQ-2 inquires about the frequency of depressed mood and anhedonia over the past two weeks. A PHQ-2 score ranges from 0-6. If the score is 3 or greater, major depressive disorder is likely. | Median | Full Range | units on a scale |
| ||||||||||||||
| Generalized Anxiety Disorder 2 (GAD-2) Score | The Generalized Anxiety Disorder 2-item (GAD-2) screens for generalized anxiety disorder 1. Two questions are asked, with the scoring of each ranging from 0-3, then both numbers added together. A total score of at least 3 points indicates possible anxiety disorder. | Median | Full Range | units on a scale |
| ||||||||||||||
| Widespread Pain Index (WPI) Score | The Widespread Pain Index (WPI) is a 19-point checklist that assesses pain or tenderness in 19 specific areas of the body within the past 7 days. Each area with pain receives point. The range in scores vary from 0-19, with 0 meaning no pain, and 19 meaning more areas of pain. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Symptom Severity Score (SS score) - Part 2a | Symptom Severity Score (SS Score) Part 2a assess symptom severity in the past 7 days in 3 categories, Fatigue, Waking unrefreshed, and cognitive symptoms. They are rated from 0 (no problem) to 3 (severe). Scores for each question are added up and used in part with section Symptom Severity 2b to get the total Symptom Severity Score. A lower score means less severe symptoms. | Median | Full Range | units on a scale |
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| Symptom Severity (SS) 2b Score | Symptom Severity Score (SS Score) Part 2b asks individuals to check a box indicating if they have had any additional symptoms over the past week. The list of symptoms include items that are possible signs of fibromyalgia. The number of symptoms checked are scored as 1 point per check. If 0 symptoms = score of 0; 1 to 10 symptoms, = score of 1; 11 to 24 = score of 2; 25 or more symptoms = score of 3. A lower score means fewer symptoms. | Median | Inter-Quartile Range | units on a scale |
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| Total Symptom Severity (SS) Score | Total Symptom Severity Score is derived using the score from Symptom Severity Score Part 2a, added to the score from Symptom Severity Score Part 2b. The Total SS ranges from 0-12, with 0 being little to no symptoms. | Mean | Standard Deviation | units on a scale |
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| 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 Revised Fibromyalgia Impact Questionnaire (FIQR) Score From Baseline to After Treatment Occurring at Weeks 8 and 18 | The FIQR (Revised Fibromyalgia Impact Questionnaire) is comprised of 21 questions spread across 3 domains: function, overall impact, symptoms, scored on an 11-point numeric rating scale. The questions are framed with the context of the past 7 days. The instructions ask the patient to rate the difficulty on a scale of 0-10 (0 = No difficulty, and 10 = Very difficult) which indicates how much difficulty they have experienced in doing the specified activity during the past 7 days. Each item is rated on a scale from 0 - 10, and the raw scores on each subscale. Then, the score on the function subscale is divided by 3, the overall impact subscale divided by 1, and the symptoms subscale divided by 2. These final scores from each subscale are then added up for the total FIQR score The total score can range from 0 -100. The total FIQR score is the sum of each section. A lower score means a better outcome. Higher scores indicate more severe impact. | Posted | Mean | 95% Confidence Interval | Score | Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 18 |
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| Secondary | Change in Pain, Enjoyment of Life and General Activity (PEG) Scale From Baseline to After Treatment Occurring at Weeks 8 and 18 | In the PEG score, a higher score indicates more severe pain and pain-related interference. The PEG has 3 separate numerical scales. Each has ratings 0-10.The first scale asks individuals to rate their pain, on average, over the past week, the second asks to rate how pain has interfered with their enjoyment of life in the past week, the third asks individuals to rate how pain has interfered with general activities. The PEG scale is scored by averaging the three numbers. The final score helps to track and monitor pain levels over time. The PEG score should decrease when treatment is effective. | Posted | Mean | 95% Confidence Interval | score on a scale | Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 18 |
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| Secondary | Change in Patient Health Questionnaire (PHQ-2) From Baseline to After Treatment Occurring at Weeks 8 and 18 | The change in depression scale (PHQ-2) by evaluating the number of days the participant feels down, depressed or hopeless and has little interest or pleasure in doing things rated as not at all (0), several days (1), more than half the days (2), or nearly every day (3) by scoring the 2 questions from 0-3 as indicated. Scores range from 0-6, with the higher score meaning the patient experiencing more severe symptoms. | Posted | Mean | 95% Confidence Interval | score on a scale | Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 18 |
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| Secondary | Change in General Anxiety Disorder (GAD-2) Score From Baseline to After Treatment Occurring at Weeks 8 and 18 | The Generalized Anxiety Disorder 2-item (GAD-2) screens for generalized anxiety disorder 1. Two questions are asked, with the scoring of each ranging from 0-3, then both numbers added together, with possible scores ranging from 0-6. A total score of at least 3 points indicates possible anxiety disorder. The higher the score, the more severe anxiety. | Posted | Mean | 95% Confidence Interval | score on a scale | Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 18 |
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| Secondary | Patient Global Impression of Change (PGIC) | Patient Global Impression of Change (PGIC) has the subject will reporting whether there was a change in their activity, limitations, symptoms, emotions and overall quality of life by rating "no change", "almost the same", "a little better", "somewhat better", "moderately better", "better" or "a great deal better". Participants will also rate degrees of change from much better (0), 5 (no change), to much worse (10). The higher the score, the worse their impression of their health status was worse than previously. Scores will range from no change to a great deal better, and from 0 (much better) to 10 (much worse). | Posted | Mean | Standard Error | units on a scale | immediately after each treatment at week 8 (first intervention) and week 18 (second intervention) |
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| Other Pre-specified | Modified 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia (Modified ACR 2010) | Participants will rate change using modified 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia (modified ACR 2010) by answering questions related to their areas of pain, amount of medication required for pain, and symptoms. | Not Posted | Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 18 | Participants |
Adverse event data was collected weekly from weeks 1-19.
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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 | Placebo | Participants will be randomized to 8 weeks of placebo, minimum 2 week washout period, and then 8 weeks of a combination minocycline (200 mg daily) and NAC (1200 mg daily) followed by a final 2 week washout Placebo followed by minocycline (200 mg daily) and NAC (1200 mg daily): Placebo followed by minocycline (200 mg daily) and NAC (1200 mg daily) | 0 | 10 | 0 | 10 | 5 | 10 |
| EG001 | Minocycline 200 mg Daily + NAC 1200mg Daily | Participants will be randomized to 8 weeks of a combination minocycline (200 mg daily) and NAC (1200 mg daily), minimum 2 week washout period, and then 8 weeks of placebo followed by a final 2 week washout minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo: minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo | 0 | 14 | 0 | 14 | 8 | 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malaise | General disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment | Other |
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| Drowsiness | General disorders | Systematic Assessment |
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| Light headedness | Nervous system disorders | Systematic Assessment |
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| Vertigo | Nervous system disorders | Systematic Assessment |
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| Photosensitivity | Nervous system disorders | Systematic Assessment |
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| Pain with swallowing | Gastrointestinal disorders | Systematic Assessment |
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| Muscle Pain | General disorders | Systematic Assessment |
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| Joint Pain | General disorders | Systematic Assessment |
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| Joint Swelling | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Red Itchy Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| Ear Ringing | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Blurry Vision | Nervous system disorders | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | General disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Itchiness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Facial Flushing | General disorders | Systematic Assessment |
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| Sun Burn | General disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Coordinator | MUSC | 843-792-1869 | nitchie@musc.edu |
| Aug 23, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 1-2 years |
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| 3-5 years |
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| 5-10 years |
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| >10 years |
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| 3-5 years |
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| 5-10 years |
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| >10 years |
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| Participants |
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