Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis (ReWRAP)

This is an interventional treatment trial for Multiple Sclerosis focused on measuring MS, RRMS, Remyelination, Repair, Multiple Sclerosis, SERM, Estrogen, BZA, Bazedoxifene, Myelin Repair, Conbriza Read More

Inclusion Criteria:

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)

Exclusion Criteria:

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