Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis

A Phase II Randomized, Double-Blind, Parallel-Group, Placebo Controlled Delayed-Start Trial to Assess the Efficacy, Safety, and Tolerability of Bazedoxifene Acetate (BZA) as a Remyelinating Agent in Patients With Multiple Sclerosis

CompletedPhase 2Relapsing MSNCT04002934

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Bazedoxifene

What it measured

Main measures

  • Myelin Water Fraction (MWF) on MRI

    3 months

    MRI lesionsMyelin repair

Other measures (23)

  • Changes in BICAMS scores

    3 months

    Thinking and memory

  • Changes in MSFC scores

    3 months

    Disability progression

  • Changes in BICAMS scores

    6 months

    Thinking and memory

  • Changes in MSFC scores

    6 months

    Disability progression

  • Myelin Water Fraction (MWF) on MRI

    6 months

    MRI lesionsMyelin repair

  • Visual Evoked Potential (VEP) P100 Latency

    3 months

    Myelin repair

  • Visual Evoked Potential (VEP) P100 Latency

    6 months

    Myelin repair

  • Novel Digital Measures of Cognition

    6 months

    Thinking and memory

  • FitBit Activity

    6 months

    Mood and sleep

  • Serum Neurofilament Light Chain (NFL) levels

    6 months

    Blood or spinal fluid markers

Who could take part

Relapsing MS · 40 to 65 · EDSS 0 to 6.0

Show the full criteria

Inclusion criteria

Expanded Inclusion Criteria: 1. Relapsing remitting Multiple Sclerosis by 2017 Revised McDonald Criteria 2. Women aged 45-65 or 40+ post-menopausal. 3. Stable immunomodulatory therapy - no switch or planned switch in \< 6 months and no change in doses in 30 days prior to screening 4. Use of contraceptive method with ≤1% failure rate during period of trial if premenopausal 5. Understand and sign informed consent. 6. EDSS 0-6.0 (inclusive) Chronic Optic Neuropathy Subgroup Inclusion Criteria (including broader inclusion criteria): 1. Expanded inclusion criteria 2. Latency delay > 118 milliseconds on baseline full-field transient pattern reversal VEP in at least one eye (electrophysiological evidence of demyelination) Expanded Exclusion Criteria: 1. Multiple Sclerosis disease duration > 25 years 2. History of significant cardiac conduction block 3. Patients with a known, suspected or past history of breast, gynecological, or gastrointestinal cancer 4. Suicidal ideation or behavior in 6 months prior to baseline 5. Pregnancy, breastfeeding, or planning to become pregnant 6. Included with other study protocol simultaneously without prior approval 7. Concomitant or prior use of any other putative remyelinating therapy as determined by investigator, including but not limited to Clemastine, Duavee, and Tamoxifen. 8. Serum creatinine > 1.5mg/dL; AST, ALT, or alkaline phosphatase > 2 times the upper limit of normal 9. History of drug or alcohol abuse within the past year 10. Untreated B12 deficiency (as determined by B12 serological assessments and metabolites including methylmalonic acid [MMA] and homocysteine) or untreated hypothyroidism 11. Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal or other major diseases that in the PI's judgement may affect interpretation of study results or patient safety. 12. History of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator would preclude participation in the study. 13. Patients whose lack of mobility exposes them to an increased risk of venous thromboembolism 14. Patients with undiagnosed uterine bleeding 15. Patients with unknown, suspected or past history of breast cancer 16. Patients with known or suspected estrogen-dependent neoplasia 17. Patients with active or a past history of venous thromboembolism 18. Patients with active or a past history of arterial thromboembolism 19. Patients with known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders 20. Patients with hypersensitivity (angioedema, anaphylaxis) to estrogens, bazedoxifene, or any ingredients 21. Patients with known hepatic impairment or disease Chronic Optic Neuropathy Subgroup Exclusion Criteria: 1. Expanded exclusion criteria 2. Optic neuritis in prior 6 months 3. Known optic neuritis in involved eye ≥ 15 years ago 4. Major ophthalmologic disease/Concomitant ophthalmologic disorders (e.g. diabetes, macular degeneration, glaucoma, severe myopia, etc.). 5. Myopia > -7 Diopters (severe myopia) 6. Disc hemorrhages in qualifying eye 7. No light perception in qualifying eye 8. Simultaneous bilateral optic neuritis 9. Cotton wool spots in qualifying eye 10. Macular star in qualifying eye

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The primary goal of this study is to assess the efficacy of bazedoxifene (BZA) as remyelinating agent in patients with relapsing-remitting multiple sclerosis (RRMS). The investigators will utilize electrophysiologic techniques and magnetic resonance imaging to quantify the effect of treatment in 50 women over the course of 6 months. Participants may remain on their standard disease modifying treatment during the course of the trial but may not concurrently participate in any other investigational new drug research study.

Papers

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History

    1. Started

      Sept 2019

    2. Main results due

      May 2025

    3. Finished

      May 2025

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