Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis (NCT04002934) | Clinical Trial Compass
CompletedPhase 2
Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis
United States63 participantsStarted 2019-09-10
Plain-language summary
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.
Who can participate
Age range
40 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Relapsing remitting Multiple Sclerosis by 2017 Revised McDonald Criteria
. Women aged 45-65 or 40+ post-menopausal.
. Stable immunomodulatory therapy - no switch or planned switch in \< 6 months and no change in doses in 30 days prior to screening
. Use of contraceptive method with ≤1% failure rate during period of trial if premenopausal
. Understand and sign informed consent.
. EDSS 0-6.0 (inclusive)
. Expanded inclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Latency delay \> 118 milliseconds on baseline full-field transient pattern reversal VEP in at least one eye (electrophysiological evidence of demyelination)
Exclusion criteria
. Multiple Sclerosis disease duration \> 25 years
. History of significant cardiac conduction block
. Patients with a known, suspected or past history of breast, gynecological, or gastrointestinal cancer
. Suicidal ideation or behavior in 6 months prior to baseline
. Pregnancy, breastfeeding, or planning to become pregnant
. Included with other study protocol simultaneously without prior approval
. Concomitant or prior use of any other putative remyelinating therapy as determined by investigator, including but not limited to Clemastine, Duavee, and Tamoxifen.
. Serum creatinine \> 1.5mg/dL; AST, ALT, or alkaline phosphatase \> 2 times the upper limit of normal