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Selective Estrogen Receptor Modulator

Bazedoxifene Acetate for Multiple Sclerosis (ReWRAP Trial)

Phase 2
Recruiting
Led By Riley M Bove, MD MMSc
Research Sponsored by Riley Bove, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
RNFL > 70 microns on SD-OCT in the same eye meeting criteria for latency delay (sufficient axons)
EDSS 0-6.0 (inclusive)
Must not have
Patients with known hepatic impairment or disease
Patients with known or suspected estrogen-dependent neoplasia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of bazedoxifene on myelin in women with RRMS.

Who is the study for?
This trial is for women aged 45-65 with relapsing-remitting multiple sclerosis (RRMS) who have been on stable immunomodulatory therapy. They must not be pregnant, planning pregnancy, or breastfeeding and should use effective contraception. Participants cannot have severe myopia, a history of certain cancers or thromboembolism, untreated B12 deficiency or hypothyroidism, significant cardiac issues, or drug/alcohol abuse in the past year.
What is being tested?
The study tests bazedoxifene acetate's ability to repair nerve insulation (remyelination) in RRMS patients over six months. It uses electrophysiological techniques and MRI while participants continue their standard MS treatments. Women can't join other drug studies during this time.
What are the potential side effects?
Potential side effects may include increased risk of blood clots (venous thromboembolism), hypersensitivity reactions like angioedema or anaphylaxis due to estrogens or bazedoxifene ingredients, and possibly undiagnosed uterine bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My eye test shows enough nerve fibers.
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My disability level allows me to walk at least with a cane.
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I have been officially diagnosed with relapsing-remitting MS.
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I am a woman aged 45-65 or over 40 and post-menopausal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a known liver condition.
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My cancer is or might be fueled by estrogen.
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I have had or currently have blood clots in my veins.
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I have a history of serious heart rhythm problems.
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I have not treated my B12 deficiency or hypothyroidism.
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I have inflammation in both of my optic nerves at the same time.
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I have had or currently have blood clots in my arteries.
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I have or might have had breast cancer in the past.
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I have had Multiple Sclerosis for more than 25 years.
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I have unexplained bleeding from my uterus.
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I have a known blood clotting disorder.
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I do not have serious eye diseases like diabetes-related eye problems, macular degeneration, glaucoma, or severe nearsightedness.
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I have had cancer before, but not skin cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Myelin Water Fraction (MWF) on MRI
Secondary study objectives
12-Item Multiple Sclerosis Walking Scale (MSWS-12)
36-Item Short Form Survey (SF36)
Bladder Control Scale (BLCS)
+16 more
Other study objectives
Tolerability and Safety of BZA - Monitoring MS Relapses
Tolerability and Safety of BZA - Patient Hot Flash Diary
Tolerability and Safety of BZA - Patient Reports of Spasms
+3 more

Side effects data

From 2010 Phase 3 trial • 7609 Patients • NCT00205777
35%
Arthralgia
34%
Back pain
33%
Pain
29%
Flu syndrome
25%
Infection
25%
Abdominal pain
23%
Headache
22%
Accidental injury
22%
Hypertension
19%
Constipation
13%
Leg cramps
12%
Asthenia
12%
Diarrhea
12%
Vasodilatation
11%
Peripheral edema
11%
Urinary tract infection
10%
Dyspepsia
10%
Cough increased
10%
Dizziness
9%
Bronchitis
9%
Pharyngitis
9%
Nausea
9%
Arthrosis
9%
Insomnia
8%
Chest pain
8%
Neck pain
8%
Vertigo
8%
Cervix disorder
7%
Depression
7%
Upper respiratory infection
7%
Pruritus
6%
Hypercholesteremia
6%
Breast disorder
6%
Cystitis
6%
Vomiting
6%
Myalgia
6%
Anxiety
6%
Sinusitis
6%
Vaginitis
5%
Anorexia
5%
Gastritis
5%
Cataract specified
5%
Adverse event associated with miscellaneous factors
5%
Hyperlipemia
4%
Hyperglycemia
4%
Gastroenteritis
4%
Paresthesia
4%
Rash
4%
Dysuria
4%
Pneumonia
1%
Cerebrovascular accident
1%
Deep vein thrombosis
1%
Overdose
1%
Angina pectoris
1%
Skin carcinoma
1%
Cholelithiasis
1%
Gastrointestinal carcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Raloxifene 60 mg (Core Study)
Placebo
Bazedoxifene 20 mg
Bazedoxifene 40/ 20 mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group BExperimental Treatment1 Intervention
Group B is the "delayed-start" group and will receive a total of 3 months of BZA -- 3 months of placebo, followed by 3 months of BZA
Group II: Group AExperimental Treatment1 Intervention
Group A is the "early-start" group and will receive a total of 6 months of BZA -- 3 months of BZA, followed by 3 months BZA
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bazedoxifene Acetate
2001
Completed Phase 3
~7610

Find a Location

Who is running the clinical trial?

Riley Bove, MDLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Multiple Sclerosis
40 Patients Enrolled for Multiple Sclerosis
Riley M Bove, MD MMScPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Bazedoxifene Acetate (Selective Estrogen Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT04002934 — Phase 2
Multiple Sclerosis Research Study Groups: Group B, Group A
Multiple Sclerosis Clinical Trial 2023: Bazedoxifene Acetate Highlights & Side Effects. Trial Name: NCT04002934 — Phase 2
Bazedoxifene Acetate (Selective Estrogen Receptor Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04002934 — Phase 2
~0 spots leftby Dec 2024
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