for females ages 40-65 (full criteria)
at San Francisco, California
study started
completion around
Principal Investigator
by Riley M Bove, MD MMSc
Headshot of Riley M Bove
Riley M Bove



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.

Official Title

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


Multiple Sclerosis (MS) is a chronic neurologic disorder characterized by the loss of myelin, which results in disruption of nerve signal, damage to axons, and, ultimately, neurodegeneration. In order to treat MS, new methods for promoting repair (remyelination) are sorely needed.

There is a strong preclinical (including EAE) and epidemiologic rationale for investigating the remyelinating potential of estrogenic compounds, including evidence of endogenous (puberty, postpartum periods) and exogenous hormonal influences on MS risk and course. MS affects 3 times more women than men, and disease course in women appears overall less aggressive (on MRI, fewer T2-hyperintense demyelinated lesions develop into axonal destruction visualized as hypointense T1 "black holes").

Bazedoxifene (BZA), a third-generation SERM with extensive safety data in humans, was identified in a novel high-throughput screen (BIMA screen) for compounds capable of promoting remyelination. Subsequent analysis validated BZA's remyelinating effect in vitro and in vivo following demyelinating insult. Given strong pre-clinical support for BZA's remyelinating potential, and the clinical success of other compounds identified using the BIMA screen (Green et al., 2017), the investigators will investigate the use of BZA as a remyelinating therapy in patients with MS.


Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, MS, RRMS, Remyelination, Repair, SERM, Estrogen, BZA, Bazedoxifene, Myelin Repair, Conbriza, Relapsing-Remitting Multiple Sclerosis, Sclerosis, Bazedoxifene Acetate


You can join if…

Open to females ages 40-65

  1. Women aged 45-65 or 40+ post-menopausal.
  2. Documentation of a clinically definite diagnosis of relapsing-remitting MS
  3. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
  4. Latency delay > 118 milliseconds on baseline full-field transient pattern reversal VEP in at least one eye (electrophysiological evidence of demyelination)
  5. RNFL > 70 microns on SD-OCT in the same eye meeting criteria for latency delay (sufficient axons)
  6. Stable immunomodulatory therapy - no switch or planned switch in > 6 months and no change in doses in 30 days prior to screening
  7. Use of contraceptive method with ≤1% failure rate during period of trial if premenopausal
  8. Understand and sign informed consent.
  9. EDSS 0-6.0 (inclusive)

You CAN'T join if...

  1. Multiple Sclerosis disease duration > 25 years
  2. Optic neuritis in prior 6 months
  3. Known optic neuritis in involved eye ≥ 10 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 11. History of significant cardiac conduction block 12. History of cancer (except non-melanoma skin cancer) 13. Suicidal ideation or behavior in 6 months prior to baseline 14. Pregnancy, breastfeeding, or planning to become pregnant 15. Included with other study protocol simultaneously without prior approval 16. Concomitant or prior use of any other putative remyelinating therapy as determined by

    investigator, including but not limited to Clemastine, Duavee, and Tamoxifen.

    17. Serum creatinine > 1.5mg/dL; AST, ALT, or alkaline phosphatase > 2 times the upper

    limit of normal

    18. History of drug or alcohol abuse within the past year 19. Untreated B12 deficiency (as determined by B12 serological assessments and metabolites

    including methylmalonic acid [MMA] and homocysteine) or untreated hypothyroidism

    20. 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.

    21. 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.

    22. Patients whose lack of mobility exposes them to an increased risk of venous


    23. Patients with undiagnosed uterine bleeding 24. Patients with unknown, suspected or past history of breast cancer 25. Patients with known or suspected estrogen-dependent neoplasia 26. Patients with active or a past history of venous thromboembolism 27. Patients with active or a past history of arterial thromboembolism 28. Patients with known protein C, protein S, or antithrombin deficiency or other known

    thrombophilic disorders

    29. Patients with hypersensitivity (angioedema, anaphylaxis) to estrogens, bazedoxifene,

    or any ingredients

    30. Patients with known hepatic impairment or disease


  • Weill Institute for Neurosciences, UCSF accepting new patients
    San Francisco California 94158 United States

Lead Scientist at UCSF

  • Riley M Bove, MD MMSc
    Dr. Riley Bove is a practicing neurologist and clinician scientist in the UCSF Weill Institute for Neurosciences. Dr. Bove is a national and international leader in sex and gender aspects of Neurology, publishing, collaborating and lecturing widely on this topic.


accepting new patients
Start Date
Completion Date
Riley Bove, MD
Bove Lab Related Info
Phase 2 research study
Study Type
Expecting 50 study participants
Last Updated