NCT04594733

The Effect of Minocycline and N-acetylcysteine for the Treatment of Fibromyalgia

Completed Phase 1, PHASE2 Results posted Last updated 30 January 2024

What this trial tests

Phase 1, PHASE2 trial testing minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo in Fibromyalgia in 14 participants. Completed in 31 August 2022.

Timeline

6 December 2021

Primary endpoint
31 August 2022

31 August 2022

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	14
Start date	6 December 2021
Primary completion	31 August 2022
Estimated completion	31 August 2022
Sites	1 location across United States

Drugs / interventions tested

• minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo — full drug profile →
• Placebo followed by minocycline (200 mg daily) and NAC (1200 mg daily) — full drug profile →

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →

Sponsor

Medical University of South Carolina

Who can join

18 and older, female only, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Revised Fibromyalgia Impact Questionnaire (FIQR) Score From Baseline to After Treatment Occurring at Weeks 8 and 18 Primary · Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 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 subsc

Group	Value	95% CI
Placebo Treatment Period	4.37	-2.31 – 11.1
Minocycline (200 mg Daily) and NAC (1200 mg Daily) Treatment Period	12.1	6.30 – 17.9

Change in Pain, Enjoyment of Life and General Activity (PEG) Scale From Baseline to After Treatment Occurring at Weeks 8 and 18 Secondary · Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 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.

Group	Value	95% CI
Placebo Treatment Period	0.64	-0.36 – 1.64
Minocycline (200 mg Daily) and NAC (1200 mg Daily) Treatment Period	1.24	0.37 – 2.12

Change in Patient Health Questionnaire (PHQ-2) From Baseline to After Treatment Occurring at Weeks 8 and 18 Secondary · Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 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.

Group	Value	95% CI
Placebo Treatment Period	0.12	-0.55 – 0.80
Minocycline (200 mg Daily) and NAC (1200 mg Daily) Treatment Period	0.23	-0.38 – 0.84

Change in General Anxiety Disorder (GAD-2) Score From Baseline to After Treatment Occurring at Weeks 8 and 18 Secondary · Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 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.

Group	Value	95% CI
Placebo Treatment Period	-0.02	-0.70 – 0.66
Minocycline (200 mg Daily) and NAC (1200 mg Daily) Treatment Period	0.72	0.10 – 1.33

Patient Global Impression of Change (PGIC) Secondary · 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)

Group	Value	95% CI
Placebo Treatment Period	1.6	± 0.72
Minocycline (200 mg Daily) and NAC (1200 mg Daily) Treatment Period	2.8	± 0.79

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected weekly from weeks 1-19.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/10 (0%)

Deaths: 0/10

Minocycline 200 mg Daily + NAC 1200mg Daily

Serious: 0/14 (0%)

Deaths: 0/14

Other adverse events (25 terms — click to expand)

Reaction	System	Placebo	Minocycline 200 mg Daily +…
Malaise	General disorders	—	—
Joint Pain	General disorders	—	—
Muscle Pain	General disorders	—	—
Drowsiness	General disorders	—	—
Fatigue	General disorders	—	—
Dizziness	General disorders	—	—
Headache	Nervous system disorders	—	—
Abdominal Pain	Gastrointestinal disorders	—	—
Other	General disorders	—	—
Light headedness	Nervous system disorders	—	—
Photosensitivity	Nervous system disorders	—	—
Joint Swelling	General disorders	—	—
Ear Ringing	General disorders	—	—
Blurry Vision	Nervous system disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Nausea	General disorders	—	—
Vertigo	Nervous system disorders	—	—
Pain with swallowing	Gastrointestinal disorders	—	—
Red Itchy Rash	Skin and subcutaneous tissue disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Itchiness	Skin and subcutaneous tissue disorders	—	—
Facial Flushing	General disorders	—	—
Sun Burn	General disorders	—	—
Palpitations	Cardiac disorders	—	—

Data from ClinicalTrials.gov NCT04594733 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.