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

NCT04594733 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 00102425
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change in Pain, Enjoyment of Life and General Activity (PEG) Scale From Baseline to After Treatment Occurring at Weeks 8 and 18

  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

  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

  Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 18

• Patient Global Impression of Change (PGIC)

  immediately after each treatment at week 8 (first intervention) and week 18 (second intervention)

Other Outcomes (1)

• Modified 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia (Modified ACR 2010)

  Evaluated at baseline (prior to intervention) then again after treatment which occurs at week 8 and week 18

Study Arms (2)

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

Drug: Placebo followed by minocycline (200 mg daily) and NAC (1200 mg daily)

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

Drug: minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo

Interventions

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

minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo

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)

Placebo followed by minocycline (200 mg daily) and NAC (1200 mg daily)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Age 18 years or older
• Diagnosis of fibromyalgia for at least 6 months (confirmed by the modified 2010 ACR Diagnostic Criteria for Fibromyalgia Widespread Pain Inventory and Symptom Severity Scale)
• Currently on birth control or unable to become pregnant

You may not qualify if:

• Known hypersensitivity to minocycline or tetracycline antibiotics or to N-acetylcysteine
• Current opioid therapy or planned initiation of opioid therapy
• Active pregnancy, lactation or plans to become pregnant in the next 6 months
• Significant hepatic disease as indicated by an AST or ALT greater than twice the upper limits of normal or bilirubin greater than twice the upper limits of normal
• Significant renal disease as indicated by an estimated glomerular filtration rate less than 60 mL/min/1.73m2 at baseline or during the first washout period
• History of autoimmune syndromes (systemic lupus erythematosus, myasthenia gravis, rheumatoid arthritis,
• History of intracranial hypertension or pseudotumor cerebri
• History of IBD (Crohns disease, ulcerative colitis), Clostridium difficile infection
• History of esophagitis, esophageal obstruction, achalasia or esophageal dysmotility
• History of GI hemorrhage or known risk factors for GI hemorrhage, such as esophageal varices, peptic ulcer disease, etc.
• Subjects taking divalent and trivalent cations such as oral iron supplements, certain dietary supplements (multivitamins) that contain manganese or zinc, or antacids that contain aluminum, calcium, or magnesium, which would decrease minocycline absorption
• Subjects taking anticoagulant medication since minocycline can decrease plasma prothrombin activity
• Subjects taking isotretinoin
• Subject taking ergot alkaloids for migraines
• Subjects taking penicillin antibiotics

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Research Coordinator
• Organization: MUSC

nitchie@musc.edu

843-792-1869

Study Officials

• Michael G Hillegass, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: • 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.

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 20, 2020
• Study Start: December 6, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)