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Bazedoxifene Acetate for Multiple Sclerosis (ReWRAP Trial)
ReWRAP Trial Summary
This trial will study the effects of bazedoxifene on myelin in women with RRMS.
ReWRAP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowReWRAP Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2010 Phase 3 trial • 7609 Patients • NCT00205777ReWRAP Trial Design
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Who is running the clinical trial?
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- I have a known liver condition.My immune therapy has been stable for over 6 months with no dose changes in the last 30 days.My cancer is or might be fueled by estrogen.I have had or currently have blood clots in my veins.You have had thoughts of hurting yourself or trying to do so in the 6 months before the start of the study.My disability level allows me to walk at least with a cane.Your blood tests show high levels of creatinine, AST, ALT, or alkaline phosphatase.You have a specific eye condition called macular star in your eye.I have a history of serious heart rhythm problems.I have not used any other treatments for nerve repair.I have not treated my B12 deficiency or hypothyroidism.My eye test shows enough nerve fibers.You have cotton wool spots in your eye that meet the study's requirements.I have inflammation in both of my optic nerves at the same time.You have had problems with drugs or alcohol in the past year.I have had or currently have blood clots in my arteries.I have or might have had breast cancer in the past.I have had optic neuritis in the last 6 months.I had optic neuritis in one eye over 10 years ago.I have had Multiple Sclerosis for more than 25 years.I do not have any major health issues that could affect my safety or the study results.My limited movement increases my risk for blood clots.You have severe nearsightedness with a prescription stronger than -7.Bleeding inside the eye that meets certain conditions.You are not able to see any light with the eye being studied.I have unexplained bleeding from my uterus.I have a known blood clotting disorder.I do not have serious eye diseases like diabetes-related eye problems, macular degeneration, glaucoma, or severe nearsightedness.Your eye test shows a delay in how your nerves respond, which could be a sign of nerve damage.I have been officially diagnosed with relapsing-remitting MS.You have a severe allergic reaction to estrogens, bazedoxifene, or any of their ingredients.I am a woman aged 45-65 or over 40 and post-menopausal.I have had cancer before, but not skin cancer.
- Group 1: Group B
- Group 2: Group A
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there still openings for participation in this experiment?
"Affirmative. Clinicaltrials.gov reveals that the recruiting process for this investigation is currently underway, having first been posted on September 10th 2019 and last edited on March 21st 2022. The study requires 50 participants at 1 facility to take part in it."
Has Bazedoxifene Acetate been validated for use by the Food & Drug Administration?
"Drawing from the evidence available, our team at Power assigned bazedoxifene acetate a rating of 2 out of 3 on the safety scale. This is because it has only reached phase 2 trials; meaning while there's some data confirming its security, none can yet attest to its efficacy."
Is the age criterion of this trial open to geriatric patients?
"This trial requires that participants be between 40 and 65 years of age. Separately, there are 43 studies which cater to individuals under 18 while another 398 trials involve patients over the retirement threshold."
Could you discuss any additional research that has been conducted with Bazedoxifene Acetate?
"Currently, there are 11 ongoing clinical trials of Bazedoxifene Acetate with 1 trial in its final phase. With 24 different centres currently running studies for this drug, Boston is one of the leading cities offering these experiments."
What is the scope of this clinical trial in terms of participants?
"Affirmative. Records on clinicaltrials.gov prove that this trial, initially posted to the database on September 10th 2019, is actively recruiting participants and has been recently updated on March 21st 2022. The study requires 50 patients at a single medical centre."
Is this the inaugural attempt at conducting such a trial?
"Presently, 11 clinical trials for Bazedoxifene Acetate are being conducted across 18 cities in 5 countries. Pfizer initiated the first study of this drug back in 2017 and it completed Phase 2 approval with 160 participants involved. Since then, additional 20 studies have been launched."
Would I be able to partake in this medical experiment?
"This clinical trial seeks 50 patients aged between 40 and 65 that have a documented diagnosis of acute relapsing multiple sclerosis. In addition, those enrolled must adhere to additional criteria such as usage of contraception with low failure rates for premenopausal women, electrophysiological evidence of demyelination in one eye on VEP tests, > 70 microns RNFL detected through SD-OCT scans in the same eye meeting latency delay criteria, no changes or planned switch within immunomodulatory therapy 6 months prior to screening, understanding/signing informed consent forms, and an EDSS score ranging from 0-6.0 ("
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