Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 27 November 2023
• Main ID: NCT04002934
• Date of registration: 25/06/2019
• Prospective Registration: Yes
• Primary sponsor: Riley Bove, MD
• Public title: Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis ReWRAP
• Scientific 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
• Date of first enrolment: September 10, 2019
• Target sample size: 50
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04002934
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Stephanie Hsu

• Name: Riley M Bove, MD MMSc
• Affiliation: University of California, San Francisco

• Name: Stephanie Hsu

Key inclusion & exclusion criteria

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



Age minimum: 40 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Multiple Sclerosis

Intervention(s)

Drug: Bazedoxifene Acetate

Primary Outcome(s)

P100 Latency on Full Field Visual Evoked Potential [Time Frame: 6 months]

P100 Latency on Full Field Visual Evoked Potential [Time Frame: 3 months]

Secondary ID(s)

ReWRAP

18-24511

138495

Source(s) of Monetary Support

Please refer to primary and secondary sponsors