Multiple Sclerosis Clinical Trial
— ReWRAPOfficial 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
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | August 31, 2024 |
Est. primary completion date | February 15, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Weill Institute for Neurosciences, University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Riley Bove, MD |
United States,
Green AJ, Gelfand JM, Cree BA, Bevan C, Boscardin WJ, Mei F, Inman J, Arnow S, Devereux M, Abounasr A, Nobuta H, Zhu A, Friessen M, Gerona R, von Budingen HC, Henry RG, Hauser SL, Chan JR. Clemastine fumarate as a remyelinating therapy for multiple sclerosis (ReBUILD): a randomised, controlled, double-blind, crossover trial. Lancet. 2017 Dec 2;390(10111):2481-2489. doi: 10.1016/S0140-6736(17)32346-2. Epub 2017 Oct 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | P100 Latency on Full Field Visual Evoked Potential | The primary objective is to evaluate the efficacy of BZA relative to placebo for reducing P100 latencies on full field transient pattern reversal visual evoked potentials (VEPs). In response to a visual stimulus, cortically generated electrical potentials (VEPs) recorded over the scalp are used to measure the functional integrity of visual pathways. | 3 months | |
Primary | P100 Latency on Full Field Visual Evoked Potential | Assess whether P100 latency delay at 6 months decreases to a greater extent in Group A (exposed to BZA for 3 months during both Stage 1 and Stage 2 -- 6 months total) when compared to Group B (exposed to placebo during Stage 1 and BZA for 3 months during Stage 2 -- 3 months total). | 6 months |
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