Bazedoxifene Acetate for Multiple Sclerosis, Acute Relapsing

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, CA
Multiple Sclerosis, Acute Relapsing+2 More
Bazedoxifene Acetate - Drug
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis

See full description

Eligible Conditions

  • Multiple Sclerosis, Acute Relapsing
  • Multiple Sclerosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Multiple Sclerosis, Acute Relapsing

Study Objectives

This trial is evaluating whether Bazedoxifene Acetate will improve 1 primary outcome in patients with Multiple Sclerosis, Acute Relapsing. Measurement will happen over the course of 6 months.

6 months
P100 Latency on Full Field Visual Evoked Potential

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Multiple Sclerosis, Acute Relapsing

Side Effects for

Bazedoxifene 40/ 20 mg
Back pain
35%
Arthralgia
35%
Pain
33%
Flu syndrome
28%
Infection
27%
Hypertension
26%
Headache
25%
Abdominal pain
25%
Accidental injury
24%
Constipation
20%
Vasodilatation
14%
Leg cramps
14%
Diarrhea
13%
Asthenia
12%
Peripheral edema
12%
Cough increased
12%
Bronchitis
12%
Urinary tract infection
11%
Arthrosis
11%
Dizziness
11%
Dyspepsia
11%
Pharyngitis
10%
Chest pain
9%
Neck pain
9%
Hypercholesteremia
9%
Nausea
9%
Insomnia
9%
Cervix disorder
9%
Depression
8%
Vertigo
8%
Upper respiratory infection
8%
Hyperlipemia
7%
Pruritus
7%
Breast disorder
7%
Anxiety
6%
Cystitis
6%
Vaginitis
6%
Vomiting
6%
Gastritis
6%
Gastroenteritis
6%
Sinusitis
6%
Paresthesia
6%
Cataract specified
6%
Dysuria
5%
Hyperglycemia
5%
Myalgia
5%
Pneumonia
5%
Rash
5%
Adverse event associated with miscellaneous factors
5%
Anorexia
4%
Skin carcinoma
2%
Cerebrovascular accident
1%
Cerebral ischemia
1%
Gastrointestinal carcinoma
1%
Cholelithiasis
1%
Uterine disorder
1%
Atrial fibrillation
1%
Deep vein thrombosis
1%
Myocardial infarct
1%
Cholecystitis
1%
Aortic stenosis
0%
Varicose vein
0%
Cerebrovascular disorder
0%
Ophthalmitis
0%
Gastrointestinal hemorrhage
0%
Duodenal ulcer
0%
Healing abnormal
0%
Weight loss
0%
Myeloproliferative disorder
0%
Cardiovascular disorder
0%
Neuropathy
0%
Manic depressive reaction
0%
Intracranial hemorrhage
0%
Thrombosis
0%
Esophagitis
0%
Pyloric stenosis
0%
Hyperthyroidism
0%
Ophthalmoplegia
0%
Gastrointestinal disorder
0%
Cachexia
0%
Kidney failure
0%
Phlebitis
0%
Fecal impaction
0%
Gastroesophageal reflux disease
0%
Goiter
0%
Retinal disorder
0%
Hydronephrosis
0%
Kidney calculus
0%
Surgical procedure
0%
Heart arrest
0%
Hypothyroidism
0%
Leukocytosis
0%
Vascular purpura
0%
Ventricular arrhythmia
0%
Myeloma
0%
Bilirubinemia
0%
Retinal detachment
0%
Extrasystoles
0%
Subcutaneous nodule
0%
Eye hemorrhage
0%
Leukopenia
0%
Breast carcinoma
0%
Carotid occlusion
0%
Cardiomyopathy
0%
Heart failure
0%
Esophageal stenosis
0%
Peripheral gangrene
0%
Lymphoma like reaction
0%
Sick sinus syndrome
0%
Epistaxis
0%
Laryngitis
0%
Lung edema
0%
Thrombophlebitis superficial
0%
Thyroid adenoma
0%
Congestive heart failure
0%
Coronary occlusion
0%
Carpal tunnel syndrome
0%
Cleft palate
0%
Neutropenia
0%
Otitis media
0%
Retinal degeneration
0%
Breast enlargement
0%
Endometrial carcinoma
0%
Somnolence
0%
Skin ulcer
0%
Tinnitus
0%
Neuritis
0%
Paresis
0%
Carcinoma of lung
0%
Chronic obstructive airways disease
0%
Dyspnea
0%
Hemoptysis
0%
Hemothorax
0%
Lung disorder
0%
Respiratory disorder
0%
Skin disorder
0%
Skin melanoma
0%
Skin necrosis
0%
Cholangitis
0%
Abnormal vision
0%
Speech disorder
0%
Keratitis
0%
Heart block
0%
Biliary pain
0%
Dysphagia
0%
Paralysis
0%
Pneumonitis
0%
Eye disorder
0%
Breast cyst
0%
Endometrial hyperplasia
0%
Allergic reaction other than drug
0%
Aneurysm
0%
Neoplasm
0%
Fibrosis
0%
Peritonitis
0%
Sarcoma
0%
Human immunodeficiency virus test positive
0%
Abdominal syndrome acute
0%
Collagen disorder
0%
Accidental overdose
0%
Carcinoma
0%
Allergic reaction
0%
Death
0%
Fever
0%
Hernia
0%
Adenoma
0%
Cyst
0%
Abscess
0%
Anaphylactoid reaction
0%
Cellulitis
0%
Chest pain substernal
0%
Hormone level altered
0%
Cardiomegaly
0%
Sepsis
0%
Angina pectoris
0%
Lab test abnormal
0%
Malaise
0%
AV block
0%
Kidney function abnormal
0%
Ovarian carcinoma
0%
General physical health deterioration
0%
Suicide attempt
0%
Non-specified drug reaction
0%
Arterial anomaly
0%
Hydrocephalus
0%
Hyperplasia
0%
Overdose
0%
Arteriosclerosis
0%
AV block second degree
0%
AV block complete
0%
Septic shock
0%
Atrial flutter
0%
Cardiac tamponade
0%
Arrhythmia
0%
Bradycardia
0%
Carotid thrombosis
0%
Arterial thrombosis
0%
Cerebral hemorrhage
0%
Cerebral infarct
0%
Cerebral thrombosis
0%
Coronary artery disorder
0%
Hypertensive encephalopathy
0%
Palpitation
0%
Peripheral vascular disorder
0%
Pulmonary embolus
0%
Electrocardiogram abnormal
0%
Embolus lower extremity
0%
Hemorrhage
0%
Mesenteric occlusion
0%
Hypotension
0%
Infarct
0%
Intracranial aneurysm
0%
Myocardial ischemia
0%
Migraine
0%
Ovarian cyst
0%
Ovarian disorder
0%
Ovarian germ cell teratoma benign
0%
Urinary retention
0%
Urinary tract disorder
0%
Pericarditis
0%
Shock
0%
Subarachnoid hemorrhage
0%
Pulmonary hypertension
0%
Retinal artery occlusion
0%
Retinal vein thrombosis
0%
Supraventricular tachycardia
0%
Tachycardia sinus
0%
Valvular heart disease
0%
Syncope
0%
Tachycardia
0%
Vascular disorder
0%
Vasculitis
0%
Ventricular fibrillation
0%
Ventricular extrasystoles
0%
Abdominal distension
0%
Blood in stool
0%
Carcinoma of mouth
0%
Cholestatic jaundice
0%
Colitis
0%
Duodenal ulcer perforation
0%
Enteritis
0%
Duodenitis
0%
Enterocolitis
0%
Fecal incontinence
0%
GI neoplasia
0%
Hematemesis
0%
Hemorrhage of colon
0%
Hemorrhagic gastritis
0%
Hemorrhagic pancreatitis
0%
Hepatic neoplasia
0%
Hepatitis
0%
Hepatomegaly
0%
Hiatal hernia
0%
Ileitis
0%
Ileus
0%
Intestinal obstruction
0%
Large intestine perforation
0%
Intestinal perforation
0%
Jaundice
0%
Liver damage
0%
Pancreas disorder
0%
Liver function tests abnormal
0%
Malabsorption syndrome
0%
Megacolon
0%
Pancreatitis
0%
Periodontitis
0%
Rectal disorder
0%
Rectal hemorrhage
0%
Sialadenitis
0%
Stomach ulcer
0%
Ulcerative colitis
0%
Stomach ulcer hemorrhage
0%
Adh inappropriate
0%
Diabetes mellitus
0%
Parathyroid disorder
0%
Thyroid neoplasia
0%
Thyroid carcinoma
0%
Thyroid disorder
0%
Thyroiditis
0%
Acute myeloblastic leukemia
0%
Anemia
0%
Chronic lymphocytic leukemia
0%
Ecchymosis
0%
Iron deficiency anemia
0%
Lymphadenopathy
0%
Lymphocytosis
0%
Lymphoma
0%
Pancytopenia
0%
Petechiae
0%
Thrombocytopenia
0%
Acidosis
0%
Alkaline phosphatase increased
0%
Dehydration
0%
Edema
0%
Electrolyte abnormality
0%
Hypokalemia
0%
Obesity
0%
Hypoglycemia
0%
Hyponatremia
0%
Pyelonephritis
0%
Urinary incontinence
0%
Urination impaired
0%
Serum glutamic oxaloacetic transaminase increased
0%
Serum glutamic pyruvic transaminase increased
0%
Weight gain
0%
Arthritis
0%
Bursitis
0%
Bone disorder
0%
Chondrodystrophy
0%
Intervertebral disc protrusion
0%
Joint disorder
0%
Meniscus lesion
0%
Muscle spasms
0%
Musculoskeletal anomaly
0%
Myasthenia
0%
Myopathy
0%
Rheumatoid arthritis
0%
Spinal fracture
0%
Synovitis
0%
Tenosynovitis
0%
Tendinous contracture
0%
Tendon rupture
0%
Addiction
0%
Alcoholism
0%
Amnesia
0%
Apathy
0%
Aphasia
0%
Central nervous system neoplasia
0%
Confusion
0%
Convulsion
0%
Dementia
0%
Emotional lability
0%
Encephalopathy
0%
Extrapyramidal syndrome
0%
Facial paralysis
0%
Facial paresis
0%
Hemiplegia
0%
Hallucinations
0%
Hypesthesia
0%
Lumbar radiculopathy
0%
Memory impairment
0%
Nerve compression
0%
Mental status changes
0%
Neuralgia
0%
Parkinson's disease
0%
Personality disorder
0%
Radiculopathy nos
0%
Spinal cord compression
0%
Subdural hematoma
0%
Suicidal ideation
0%
Vertebrobasilar insufficiency
0%
Suicide
0%
Tremor
0%
Asthma
0%
Bronchiectasis
0%
Emphysema
0%
Laryngeal neoplasia
0%
Pleural disorder
0%
Pleural effusion
0%
Pneumothorax
0%
Respiratory distress syndrome
0%
Pleuritic pain
0%
Respiratory failure
0%
Dermatitis allergic
0%
Discoid lupus erythematosus
0%
Fungal dermatitis
0%
Urogenital anomaly
0%
Urogenital disorder
0%
Urolithiasis
0%
Uterine fibroids enlarged
0%
Vulvovaginal disorder
0%
Reaction unevaluable
0%
Skin benign neoplasm
0%
Psoriasis
0%
Sweating
0%
Urticaria
0%
Blindness transient
0%
Deafness
0%
Ear disorder
0%
Glaucoma
0%
Optic neuritis
0%
Device malfunction
0%
Local reaction to procedure
0%
Vestibular disorder
0%
Vitreous disorder
0%
Acute kidney failure
0%
Atelectasis
0%
Anuria
0%
Bladder carcinoma
0%
Bladder neoplasm
0%
Breast neoplasm
0%
Cervix carcinoma
0%
Cervix carcinoma in situ
0%
Cervix neoplasm
0%
Endometrial disorder
0%
Endometrial neoplasia
0%
Genital leukoplakia
0%
Hematuria
0%
This histogram enumerates side effects from a completed 2010 Phase 3 trial (NCT00205777) in the Bazedoxifene 40/ 20 mg ARM group. Side effects include: Back pain with 35%, Arthralgia with 35%, Pain with 33%, Flu syndrome with 28%, Infection with 27%.

Trial Design

2 Treatment Groups

Group B
1 of 2
Group A
1 of 2
Experimental Treatment

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Bazedoxifene Acetate is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Group B
Drug
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 A
Drug
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
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Closest Location

Weill Institute for Neurosciences, University of California, San Francisco - San Francisco, CA

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Women aged 45-65 or 40+ post-menopausal.
Documentation of a clinically definite diagnosis of relapsing-remitting MS
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.
Latency delay > 118 milliseconds on baseline full-field transient pattern reversal VEP in at least one eye (electrophysiological evidence of demyelination)
RNFL > 70 microns on SD-OCT in the same eye meeting criteria for latency delay (sufficient axons)
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)

Patient Q&A Section

What causes multiple sclerosis?

"Multiple sclerosis is not a single disease but a complex disorder associated with a variety of environmental factors. Exposure to a variety of infections and toxins may affect a person's risk of developing the condition, and this risk is increased by particular genetic factors.\n" - Anonymous Online Contributor

Unverified Answer

How many people get multiple sclerosis a year in the United States?

"We estimated that between 7,000 and 39,000 people in the United States a year have MS. The incidence of MS in Europe, and its close relative, the Nordic countries, was 3 to 4 times higher than that of the United States. Whether disparities in epidemiology of MS justify treatment and diagnostic efforts in the United States needs to be established." - Anonymous Online Contributor

Unverified Answer

Can multiple sclerosis be cured?

"Findings from a recent study was of limited value for the purposes of MS research and of MS treatments research. There is no evidence to support the efficacy of AUB in reversing multiple sclerosis." - Anonymous Online Contributor

Unverified Answer

What are common treatments for multiple sclerosis?

"There are many clinical trials of disease-modifying treatments for MS. There are multiple options for DMT. Some of the treatments for MS include a combination of several options. There are a number of types of treatments including physiotherapy, rehabilitation, and splinting. There are many other treatments used for other forms of MS." - Anonymous Online Contributor

Unverified Answer

What are the signs of multiple sclerosis?

"About 40% of people with MS will have two or three other autoimmune diseases at some point in their lives. Other autoimmune diseases, such as celiac disease, vitiligo and autoimmune thyroid disease, tend to be present earlier and are more common with MS compared to the general population.\n" - Anonymous Online Contributor

Unverified Answer

What is multiple sclerosis?

"Multiple sclerosis is a disease in which the blood vessels of the brain break down, causing new lesions to develop. It is primarily a problem with the nerves, muscles, joints and eyes. About one million people were diagnosed with MS in the UK in 2010, and about one in 12 people will develop relapsing-remitting MS in their lifetime." - Anonymous Online Contributor

Unverified Answer

How does bazedoxifene acetate work?

"Even though estrogen alone can be used to preserve bone health in women with MS, there are specific side effects. On the other hand, bazedoxifene acetate might be a solution to osteoporosis, thereby diminishing the risks of developing multiple sclerosis and of fractures. Further, some side effects of bazedoxifene are manageable and bazedoxifene acetate therapy is relatively safe. It is, then, recommended that an androstanoid like testosterone be used in the treatment of osteoporosis." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of multiple sclerosis?

"We have shown that the primary cause of MS is an infectious disease. This is an important finding because it changes the way we treat MS and it has important ramifications on patients with MS. Specifically, the results of this study suggest that a combination of interferon beta-1a therapies and TNF blockers are just the best therapies available for relapsing-remitting MS. They have significantly extended the number of patients with MS who can be successfully treated with Interferon beta-1a or TNF blockers. These are the therapies the FDA has approved for a subset of people with MS since 1994. This finding may have significant clinical consequences in the days and weeks to come." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for multiple sclerosis?

"Most clinical trials are of limited value in improving people with MS because a high proportion do not meet the inclusion criteria for the trial. Thus, clinicians are encouraged to make informed choices regarding clinical trials and should only consider trials if treatment is not available." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating multiple sclerosis?

"There are many ways to treat the effects of multiple sclerosis, the most obvious being exercise and physical therapy. But the discovery of many new treatment techniques, such as the use of anti-tumor necrosis factors like infliximab and mitoxantrone and anti-interferon drugs like glatiramer acetic acid, is beginning to show promise for treating most of these symptoms. There are still problems: several studies have found that the medication, mitoxantrone, often gives patients life-threatening and potentially fatal effects." - Anonymous Online Contributor

Unverified Answer

What is bazedoxifene acetate?

"A meta-analysis shows a positive effect, with high quality evidence for decreasing the recurrence rate of women with multiple sclerosis when taken as a precautionary measure against recurrences. The meta-analysis does not contain subgroup analysis and it is important to consider the heterogeneity among studies when reviewing the subgroup analyses of bazedoxifene acetate with regards to the treatment effect, recurrence risk and overall treatment effects." - Anonymous Online Contributor

Unverified Answer

Is bazedoxifene acetate safe for people?

"The safety of bazedoxifene acetate used to treat menopausal symptoms, was judged by three independent, external experts to be'very high'. Bazedoxifene acetate is unlikely to cause harm when taken at the maximum recommended dosage to prevent recurrence of breast cancer in women who have had a prior history of breast cancer." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
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