Trial Outcomes & Findings for The Effect of Minocycline and N-acetylcysteine for the Treatment of Fibromyalgia (NCT NCT04594733)
NCT ID: NCT04594733
Last Updated: 2024-01-30
Results Overview
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.
COMPLETED
PHASE1/PHASE2
14 participants
Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 18
2024-01-30
Participant Flow
Participant milestones
| Measure |
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)
|
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
|
|---|---|---|
|
First Intervention (8 Weeks)
STARTED
|
7
|
7
|
|
First Intervention (8 Weeks)
Received Intervention
|
7
|
7
|
|
First Intervention (8 Weeks)
COMPLETED
|
7
|
3
|
|
First Intervention (8 Weeks)
NOT COMPLETED
|
0
|
4
|
|
First Washout (2 Weeks)
STARTED
|
7
|
3
|
|
First Washout (2 Weeks)
COMPLETED
|
7
|
3
|
|
First Washout (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (8 Weeks)
STARTED
|
7
|
3
|
|
Second Intervention (8 Weeks)
COMPLETED
|
5
|
3
|
|
Second Intervention (8 Weeks)
NOT COMPLETED
|
2
|
0
|
|
Second Washout (2 Weeks)
STARTED
|
5
|
3
|
|
Second Washout (2 Weeks)
COMPLETED
|
5
|
3
|
|
Second Washout (2 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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)
|
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
|
|---|---|---|
|
First Intervention (8 Weeks)
Withdrawal by Subject
|
0
|
1
|
|
First Intervention (8 Weeks)
Lost to Follow-up
|
0
|
3
|
|
Second Intervention (8 Weeks)
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
The Effect of Minocycline and N-acetylcysteine for the Treatment of Fibromyalgia
Baseline characteristics by cohort
| Measure |
Placebo Followed by Minocycline (200 mg Daily) and NAC (1200 mg Daily)
n=7 Participants
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)
|
Minocycline (200 mg Daily) and NAC (1200 mg Daily) Followed by Placebo
n=7 Participants
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
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 17.2 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 9.98 • n=7 Participants
|
48.4 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Duration of Formal Diagnosis
0-1 years
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Duration of Formal Diagnosis
1-2 years
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Duration of Formal Diagnosis
3-5 years
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Duration of Formal Diagnosis
5-10 years
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Duration of Formal Diagnosis
>10 years
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Duration of Symptoms
1-2 years
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Duration of Symptoms
3-5 years
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Duration of Symptoms
5-10 years
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Duration of Symptoms
>10 years
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Fibromyalgia Impact Questionnaire (FIQR) Score
|
67.6 units on a scale
STANDARD_DEVIATION 12.9 • n=5 Participants
|
58.4 units on a scale
STANDARD_DEVIATION 16.2 • n=7 Participants
|
63.0 units on a scale
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
The Pain, Enjoyment of Life and General Activity (PEG) Score
|
7.29 units on a scale
STANDARD_DEVIATION 1.20 • n=5 Participants
|
6.90 units on a scale
STANDARD_DEVIATION 1.74 • n=7 Participants
|
7.10 units on a scale
STANDARD_DEVIATION 1.41 • n=5 Participants
|
|
Patient Health Questionnaire-2 (PHQ-2) Score
|
4 units on a scale
n=5 Participants
|
2 units on a scale
n=7 Participants
|
2 units on a scale
n=5 Participants
|
|
Generalized Anxiety Disorder 2 (GAD-2) Score
|
2 units on a scale
n=5 Participants
|
2 units on a scale
n=7 Participants
|
2 units on a scale
n=5 Participants
|
|
Widespread Pain Index (WPI) Score
|
14.3 units on a scale
STANDARD_DEVIATION 3.90 • n=5 Participants
|
10.6 units on a scale
STANDARD_DEVIATION 4.12 • n=7 Participants
|
12.4 units on a scale
STANDARD_DEVIATION 4.31 • n=5 Participants
|
|
Symptom Severity Score (SS score) - Part 2a
|
7 units on a scale
n=5 Participants
|
5 units on a scale
n=7 Participants
|
6 units on a scale
n=5 Participants
|
|
Symptom Severity (SS) 2b Score
|
1 units on a scale
n=5 Participants
|
2 units on a scale
n=7 Participants
|
1.5 units on a scale
n=5 Participants
|
|
Total Symptom Severity (SS) Score
|
8.57 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
7.14 units on a scale
STANDARD_DEVIATION 2.34 • n=7 Participants
|
7.86 units on a scale
STANDARD_DEVIATION 2.18 • n=5 Participants
|
PRIMARY outcome
Timeframe: Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 18The 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.
Outcome measures
| Measure |
Placebo Treatment Period
n=10 Participants
Participants will be randomized to 8 weeks of placebo
|
Minocycline (200 mg Daily) and NAC (1200 mg Daily) Treatment Period
n=7 Participants
Participants will be randomized to 8 weeks of a combination minocycline (200 mg daily) and NAC (1200 mg daily).
|
|---|---|---|
|
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) Score From Baseline to After Treatment Occurring at Weeks 8 and 18
|
4.37 Score
Interval -2.31 to 11.1
|
12.1 Score
Interval 6.3 to 17.9
|
SECONDARY outcome
Timeframe: Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 18In 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.
Outcome measures
| Measure |
Placebo Treatment Period
n=10 Participants
Participants will be randomized to 8 weeks of placebo
|
Minocycline (200 mg Daily) and NAC (1200 mg Daily) Treatment Period
n=7 Participants
Participants will be randomized to 8 weeks of a combination minocycline (200 mg daily) and NAC (1200 mg daily).
|
|---|---|---|
|
Change in Pain, Enjoyment of Life and General Activity (PEG) Scale From Baseline to After Treatment Occurring at Weeks 8 and 18
|
0.64 score on a scale
Interval -0.36 to 1.64
|
1.24 score on a scale
Interval 0.37 to 2.12
|
SECONDARY outcome
Timeframe: Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 18The 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.
Outcome measures
| Measure |
Placebo Treatment Period
n=10 Participants
Participants will be randomized to 8 weeks of placebo
|
Minocycline (200 mg Daily) and NAC (1200 mg Daily) Treatment Period
n=7 Participants
Participants will be randomized to 8 weeks of a combination minocycline (200 mg daily) and NAC (1200 mg daily).
|
|---|---|---|
|
Change in Patient Health Questionnaire (PHQ-2) From Baseline to After Treatment Occurring at Weeks 8 and 18
|
0.12 score on a scale
Interval -0.55 to 0.8
|
0.23 score on a scale
Interval -0.38 to 0.84
|
SECONDARY outcome
Timeframe: Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 18The 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.
Outcome measures
| Measure |
Placebo Treatment Period
n=10 Participants
Participants will be randomized to 8 weeks of placebo
|
Minocycline (200 mg Daily) and NAC (1200 mg Daily) Treatment Period
n=7 Participants
Participants will be randomized to 8 weeks of a combination minocycline (200 mg daily) and NAC (1200 mg daily).
|
|---|---|---|
|
Change in General Anxiety Disorder (GAD-2) Score From Baseline to After Treatment Occurring at Weeks 8 and 18
|
-0.02 score on a scale
Interval -0.7 to 0.66
|
0.72 score on a scale
Interval 0.1 to 1.33
|
SECONDARY outcome
Timeframe: immediately after each treatment at week 8 (first intervention) and week 18 (second intervention)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).
Outcome measures
| Measure |
Placebo Treatment Period
n=10 Participants
Participants will be randomized to 8 weeks of placebo
|
Minocycline (200 mg Daily) and NAC (1200 mg Daily) Treatment Period
n=7 Participants
Participants will be randomized to 8 weeks of a combination minocycline (200 mg daily) and NAC (1200 mg daily).
|
|---|---|---|
|
Patient Global Impression of Change (PGIC)
|
1.6 units on a scale
Standard Error 0.72
|
2.8 units on a scale
Standard Error 0.79
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 18Participants 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.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Minocycline 200 mg Daily + NAC 1200mg Daily
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=10 participants at risk
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)
|
Minocycline 200 mg Daily + NAC 1200mg Daily
n=14 participants at risk
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
|
|---|---|---|
|
General disorders
Malaise
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected weekly from weeks 1-19.
|
35.7%
5/14 • Number of events 5 • Adverse event data was collected weekly from weeks 1-19.
|
|
General disorders
Other
|
20.0%
2/10 • Number of events 2 • Adverse event data was collected weekly from weeks 1-19.
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected weekly from weeks 1-19.
|
|
General disorders
Drowsiness
|
0.00%
0/10 • Adverse event data was collected weekly from weeks 1-19.
|
21.4%
3/14 • Number of events 3 • Adverse event data was collected weekly from weeks 1-19.
|
|
Nervous system disorders
Light headedness
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected weekly from weeks 1-19.
|
14.3%
2/14 • Number of events 2 • Adverse event data was collected weekly from weeks 1-19.
|
|
Nervous system disorders
Vertigo
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected weekly from weeks 1-19.
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected weekly from weeks 1-19.
|
|
Nervous system disorders
Photosensitivity
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected weekly from weeks 1-19.
|
14.3%
2/14 • Number of events 2 • Adverse event data was collected weekly from weeks 1-19.
|
|
Gastrointestinal disorders
Pain with swallowing
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected weekly from weeks 1-19.
|
0.00%
0/14 • Adverse event data was collected weekly from weeks 1-19.
|
|
General disorders
Muscle Pain
|
20.0%
2/10 • Number of events 2 • Adverse event data was collected weekly from weeks 1-19.
|
28.6%
4/14 • Number of events 4 • Adverse event data was collected weekly from weeks 1-19.
|
|
General disorders
Joint Pain
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected weekly from weeks 1-19.
|
35.7%
5/14 • Number of events 5 • Adverse event data was collected weekly from weeks 1-19.
|
|
General disorders
Joint Swelling
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected weekly from weeks 1-19.
|
14.3%
2/14 • Number of events 2 • Adverse event data was collected weekly from weeks 1-19.
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected weekly from weeks 1-19.
|
21.4%
3/14 • Number of events 3 • Adverse event data was collected weekly from weeks 1-19.
|
|
Skin and subcutaneous tissue disorders
Red Itchy Rash
|
0.00%
0/10 • Adverse event data was collected weekly from weeks 1-19.
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected weekly from weeks 1-19.
|
|
General disorders
Dizziness
|
0.00%
0/10 • Adverse event data was collected weekly from weeks 1-19.
|
21.4%
3/14 • Number of events 3 • Adverse event data was collected weekly from weeks 1-19.
|
|
General disorders
Ear Ringing
|
0.00%
0/10 • Adverse event data was collected weekly from weeks 1-19.
|
14.3%
2/14 • Number of events 2 • Adverse event data was collected weekly from weeks 1-19.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • Adverse event data was collected weekly from weeks 1-19.
|
21.4%
3/14 • Number of events 3 • Adverse event data was collected weekly from weeks 1-19.
|
|
Nervous system disorders
Blurry Vision
|
0.00%
0/10 • Adverse event data was collected weekly from weeks 1-19.
|
14.3%
2/14 • Number of events 2 • Adverse event data was collected weekly from weeks 1-19.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/10 • Adverse event data was collected weekly from weeks 1-19.
|
21.4%
3/14 • Number of events 3 • Adverse event data was collected weekly from weeks 1-19.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/10 • Adverse event data was collected weekly from weeks 1-19.
|
14.3%
2/14 • Number of events 2 • Adverse event data was collected weekly from weeks 1-19.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Adverse event data was collected weekly from weeks 1-19.
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected weekly from weeks 1-19.
|
|
General disorders
Nausea
|
0.00%
0/10 • Adverse event data was collected weekly from weeks 1-19.
|
14.3%
2/14 • Number of events 2 • Adverse event data was collected weekly from weeks 1-19.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • Adverse event data was collected weekly from weeks 1-19.
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected weekly from weeks 1-19.
|
|
Skin and subcutaneous tissue disorders
Itchiness
|
0.00%
0/10 • Adverse event data was collected weekly from weeks 1-19.
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected weekly from weeks 1-19.
|
|
General disorders
Facial Flushing
|
0.00%
0/10 • Adverse event data was collected weekly from weeks 1-19.
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected weekly from weeks 1-19.
|
|
General disorders
Sun Burn
|
0.00%
0/10 • Adverse event data was collected weekly from weeks 1-19.
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected weekly from weeks 1-19.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • Adverse event data was collected weekly from weeks 1-19.
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected weekly from weeks 1-19.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place