We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04594733
Recruitment Status : Completed
First Posted : October 20, 2020
Last Update Posted : October 4, 2022
Sponsor:
Information provided by (Responsible Party):
Michael Gabriel Hillegass, Medical University of South Carolina

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).

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo Drug: Placebo followed by minocycline (200 mg daily) and NAC (1200 mg daily) Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: • 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.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Minocycline and N-acetylcysteine for the Treatment of Fibromyalgia: a Double-blind, Randomized, Crossover Pilot Study
Actual Study Start Date : December 6, 2021
Actual Primary Completion Date : August 31, 2022
Actual Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Active Comparator: 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
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)

Active Comparator: 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
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




Primary Outcome Measures :
  1. Revised Fibromyalgia Impact Questionnaire (FIQR) score [ Time Frame: baseline and 20 weeks ]
    change in subject reported difficulty experienced doing various tasks rate (no difficulty) to (very difficult) utilizing the Revised Fibromyalgia Impact Questionnaire (FIQR) score.


Secondary Outcome Measures :
  1. Pain, Enjoyment of Life and General Activity Scale (PEG) [ Time Frame: baseline and 20 weeks ]
    Change in pain and interference (PEG) score based on the amount of interference pain has on a scale of 0(does not interfere)-10(completely interferes) in participant's average pain, enjoyment of life and general activity.

  2. Patient Health Questionnaire (PHQ-2)54 [ Time Frame: baseline and 20 weeks ]
    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, several days, more than half the days or nearly everyday.

  3. General Anxiety Disorder (GAD-2) [ Time Frame: baseline and 20 weeks ]
    change in anxiety (GAD-2) scale by rating feelings of being nervous, anxious or on edge & not able to stop or control worrying. Participant rates feelings as not at all, several days, more than half the days or nearly everyday.

  4. Patient Global Impression of Change (PGIC) [ Time Frame: baseline and 20 weeks ]
    Change patient global impression of change (PGIC). The subject will report whether there was a change in 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) to much worse (10)

  5. modified 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia (modified ACR 2010) [ Time Frame: baseline and 20 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • 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
  • Willingness to avoid taking opioid and opiate medications during the duration of the study (5-6 months) Exclusion Criteria
  • 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
  • Subjects taking methoxyflurane containing products
  • Subjects who work outdoors or otherwise have prolonged exposure to UV light and sunlight
  • Lack of access to reliable technology to be able to complete emailed REDCap questionnaires
  • Cognitive deficits that may make it difficult to adhere to the medication regimen or provide consistent and timely completion of questionnaires
  • Inability or unwillingness to give informed consent
  • Unwillingness to use two forms of birth control for the entire duration of participation in the study (if capable of becoming pregnant)
  • Unwillingness to complete home pregnancy tests throughout the study (if capable of becoming pregnant)
  • Inability to swallow large pills

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04594733


Locations
Layout table for location information
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Layout table for investigator information
Principal Investigator: Michael G Hillegass, MD Medical University of South Carolina
Layout table for additonal information
Responsible Party: Michael Gabriel Hillegass, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04594733    
Other Study ID Numbers: 00102425
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: October 4, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents