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Terbinafine Treatment of Axial Spondyloarthropathy (FUN)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05119712
Recruitment Status : Recruiting
First Posted : November 15, 2021
Last Update Posted : November 15, 2021
Sponsor:
Collaborator:
The Malassezia Foundation
Information provided by (Responsible Party):
Jim Rosenbaum, Oregon Health and Science University

Brief Summary:
This is a pilot study to determine if further research is warranted to assess if anti-fungal therapy is an effective adjunctive treatment for axial spondyloarthropathy

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Axial Spondyloarthritis Psoriatic Spondylitis Spondylitis Secondary to Inflammatory Bowel Disease Axial Spondyloarthopathy Drug: Terbinafine Tablets Diagnostic Test: Laboratory Testing Early Phase 1

Detailed Description:

The purpose of this trial is to determine if terbinafine is an effective therapy for ankylosing spondylitis. Benefit will be determined by a reduction of the BASDAI by two or more.

The primary endpoint is the BASDAI at the completion of 16 weeks of terbinafine versus the BASDAI at the start of the trial and at the completion of the placebo. The secondary endpoint with the percent of patients whose BASDAI improves by two or more while on terbinafine (week 16) versus the percent of subjects with a similar improvement after 16 weeks of placebo.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Subjects will receive either terbinafine 500 mg or placebo for 16 weeks and then crossed over to the opposite therapy for another 16 weeks.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Terbinafine Treatment of Axial Spondyloarthropathy
Actual Study Start Date : March 9, 2021
Estimated Primary Completion Date : October 15, 2023
Estimated Study Completion Date : October 15, 2024


Arm Intervention/treatment
Active Comparator: Placebo to Drug
Subjects will begin treatment on placebo then crossover to study drug.
Drug: Terbinafine Tablets
500mg oral terbinafine or placebo daily
Other Name: Lamisil

Diagnostic Test: Laboratory Testing
Laboratory testing at screening, baseline, week 8, 16, 24 and 32.
Other Name: Blood work

Diagnostic Test: Laboratory Testing
Subjects with the potential to become pregnant will have a baseline urine pregnancy test prior to starting study drug.
Other Name: Urinalysis

Active Comparator: Drug to Placebo
Subjects will begin treatment on study drug then crossover to placebo.
Drug: Terbinafine Tablets
500mg oral terbinafine or placebo daily
Other Name: Lamisil

Diagnostic Test: Laboratory Testing
Laboratory testing at screening, baseline, week 8, 16, 24 and 32.
Other Name: Blood work

Diagnostic Test: Laboratory Testing
Subjects with the potential to become pregnant will have a baseline urine pregnancy test prior to starting study drug.
Other Name: Urinalysis




Primary Outcome Measures :
  1. Change in BASDAI score [ Time Frame: 16 weeks ]
    BASDAI score after the completion of 16 weeks of terbinafine treatment versus the BASDAI score after 16 weeks on placebo. Benefit is defined by a reduction of BASDAI score of 2 or more.



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects age 18 and older of either sex will be included.
  • Subjects must be willing and able to provide informed consent.
  • Subjects must have been diagnosed with ankylosing spondylitis, axial spondyloarthritis, psoriatic spondylitis or spondylitis secondary to inflammatory bowel disease by a physician and must be willing to request records to validate the diagnosis.
  • Subjects must complete a symptom questionnaire called a BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and must have a score of four or above to indicate active disease and the potential to improve.
  • Subjects must agree to remain on a stable treatment regimen for their joint disease for the duration of the trial and for one month before the study begins.
  • Subjects must be willing to provide stool samples and be willing to have routine lab studies every 8 weeks during the duration of the study.

Exclusion Criteria:

  • Pregnant or lactating women will not be included.
  • Subjects must not be allergic or intolerant to terbinafine.
  • Subjects must not be taking medications that have the potential for serious interactions with terbinafine. These drugs include desipramine, cimetidine, fluconazole, cyclosporine and rifampin.
  • Subjects must not have taken antibiotics within 3 months of starting the study drug and collecting the baseline stool specimen.
  • Subjects with the following blood dyscrasias will not be included:

Hemoglobin <9g/dL or Hematocrit <30% White blood cell count <3.0 K/cu mm Absolute neutrophil count <1.2 K/cu mm Platelet count <100 K/cu mm Subjects with an estimated GFR ≤50 ml/min Subjects with a total bilirubin, AST, or ALT more than 1.5 times the upper limit of normal at screening.

  • Severe, progressive, or uncontrolled chronic liver disease including fibrosis, cirrhosis, or recent or active hepatitis.
  • History of any lymphoproliferative disorder such as Epstein Barr virus (EBV) related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggest of current lymphatic disease.
  • Current malignancy or history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
  • Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis and aspergilloma, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
  • Have a known infection with human immunodeficiency virus (HIV)
  • Have current signs and symptoms of systemic lupus erythematosus, or severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac (New York Heart Association class III or IV), neurologic, or cerebral diseases.

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): NCT05119712


Contacts
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Contact: Kimberly M Ogle (503) 494-5711 oglki@ohsu.edu

Locations
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United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Kimberly Ogle    503-494-5711    oglki@ohsu.edu   
Principal Investigator: James T Rosenbaum, M.D.         
Sponsors and Collaborators
Oregon Health and Science University
The Malassezia Foundation
Investigators
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Principal Investigator: James T Rosenbaum, M.D. Oregon Health and Science University
Publications:

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Responsible Party: Jim Rosenbaum, Professor of Ophthalmology, Medicine, and Cell Biology, OHSU, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT05119712    
Other Study ID Numbers: STUDY00021565
First Posted: November 15, 2021    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD with other researchers.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jim Rosenbaum, Oregon Health and Science University:
fungus, malassezia, microbiome
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Spondylarthritis
Spondylarthropathies
Inflammatory Bowel Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Bone Diseases, Infectious
Infections
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Ankylosis
Joint Diseases
Arthritis
Terbinafine
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action