Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis

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)

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

   thromboembolism

   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