Multiple SclerosisPhase 2ReWRAPNCT04002934
Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis
A Phase 2 study testing Bazedoxifene Acetate in people with Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Riley Bove, MD at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Bazedoxifene Acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2019to 20 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Expanded 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)
Chronic Optic Neuropathy Subgroup Inclusion Criteria (including broader inclusion criteria):
- Expanded inclusion criteria
- Latency delay > 118 milliseconds on baseline full-field transient pattern reversal VEP in at least one eye (electrophysiological evidence of demyelination)
Expanded 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
- History of drug or alcohol abuse within the past year
- Untreated B12 deficiency (as determined by B12 serological assessments and metabolites including methylmalonic acid [MMA] and homocysteine) or untreated hypothyroidism
- 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.
- 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.
- Patients whose lack of mobility exposes them to an increased risk of venous thromboembolism
- Patients with undiagnosed uterine bleeding
- Patients with unknown, suspected or past history of breast cancer
- Patients with known or suspected estrogen-dependent neoplasia
- Patients with active or a past history of venous thromboembolism
- Patients with active or a past history of arterial thromboembolism
- Patients with known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders
- Patients with hypersensitivity (angioedema, anaphylaxis) to estrogens, bazedoxifene, or any ingredients
- Patients with known hepatic impairment or disease
Chronic Optic Neuropathy Subgroup Exclusion Criteria:
- Expanded exclusion criteria
- Optic neuritis in prior 6 months
- Known optic neuritis in involved eye ≥ 15 years ago
- Major ophthalmologic disease/Concomitant ophthalmologic disorders (e.g. diabetes, macular degeneration, glaucoma, severe myopia, etc.).
- Myopia > -7 Diopters (severe myopia)
- Disc hemorrhages in qualifying eye
- No light perception in qualifying eye
- Simultaneous bilateral optic neuritis
- Cotton wool spots in qualifying eye
- Macular star in qualifying eye
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Institute for Neurosciences, University of California, San Francisco
San Francisco, California, 94158
About this study
Official 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.
Read the detailed description
Multiple Sclerosis (MS) is a chronic neurologic disorder characterized by the loss of myelin, which results in disruption of nerve signal, damage to axons, and, ultimately, neurodegeneration. In order to treat MS, new methods for promoting repair (remyelination) are sorely needed.
There is a strong preclinical (including EAE) and epidemiologic rationale for investigating the remyelinating potential of estrogenic compounds, including evidence of endogenous (puberty, postpartum periods) and exogenous hormonal influences on MS risk and course. MS affects 3 times more women than men, and disease course in women appears overall less aggressive (on MRI, fewer T2-hyperintense demyelinated lesions develop into axonal destruction visualized as hypointense T1 "black holes").
Bazedoxifene (BZA), a third-generation SERM with extensive safety data in humans, was identified in a novel high-throughput screen (BIMA screen) for compounds capable of promoting remyelination. Subsequent analysis validated BZA's remyelinating effect in vitro and in vivo following demyelinating insult. Given strong pre-clinical support for BZA's remyelinating potential, and the clinical success of other compounds identified using the BIMA screen (Green et al., 2017), the investigators will investigate the use of BZA as a remyelinating therapy in patients with MS.
- Being tested
- Bazedoxifene Acetate
- Keywords
- MS, RRMS, Remyelination, Repair, Multiple Sclerosis, SERM, Estrogen, BZA, Bazedoxifene, Myelin Repair, Conbriza
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bazedoxifene AcetateDrug
Also called Bazedoxifene, Conbriza, Viviant, TSE-424
40 mg Bazedoxifene delivered orally in the form of 2x 20 mg blinded capsules
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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 Receives: Drug: Bazedoxifene Acetate |
| Group B | Experimental | 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 Receives: Drug: Bazedoxifene Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myelin Water Fraction (MWF) on MRI
The primary objective is to evaluate the efficacy of BZA relative to placebo for increasing MWF on MRI within normal appearing white matter of the corpus callosum, between baseline and 90 days in a double-blinded trial (1st 90 days in the early start group versus 1st 90 days of the delayed start group).
Measured: 3 months
Secondary outcomes (23)
Changes in BICAMS scores
The first key secondary objective is changes in BICAMS scores over 3 months.
Measured: 3 months
Changes in MSFC scores
The second key secondary objective is changes in MSFC scores over 3 months.
Measured: 3 months
Changes in BICAMS scores
The third key secondary objective is changes in BICAMS scores over 6 months.
Measured: 6 months
Changes in MSFC scores
The fourth key secondary objective is changes in MSFC scores over 6 months.
Measured: 6 months
Myelin Water Fraction (MWF) on MRI
The fifth key secondary objective is to assess whether MWF at 180 days increases to a greater extent in the early start group (exposed to BZA for 90 days during both Stage 1 and Stage 2) when compared to the delayed start group (exposed to placebo during Stage 1 and BZA for only 90 days during Stage 2).
Measured: 6 months
Visual Evoked Potential (VEP) P100 Latency
The sixth key secondary objective is changes in visual evoked potential (VEP) P100 latency.
Measured: 3 months
Visual Evoked Potential (VEP) P100 Latency
The seventh key secondary objective is changes in visual evoked potential (VEP) P100 latency.
Measured: 6 months
Novel Digital Measures of Cognition
The eighth key secondary objective is to assess novel digital measures of cognition (processing speed from EVO Monitor).
Measured: 6 months
FitBit Activity
The ninth key secondary objective is to assess daily activity by average daily step count as well as sleep activity by various sleep metrics recorded through FitBit.
Measured: 6 months
Serum Neurofilament Light Chain (NFL) levels
The tenth key secondary objective is to assess NFL levels.
Measured: 6 months
Expanded Disability Status Scale (EDSS)
The last key secondary objective is an assessment of exploratory outcomes, including EDSS.
Measured: 6 months
Bladder Control Scale (BLCS)
The last key secondary objective is an assessment of exploratory outcomes, including the BLCS, a patient-reported outcome.
Measured: 6 months
Bowel Control Scale (BWCS)
The last key secondary objective is an assessment of exploratory outcomes, including the BWCS, a patient-reported outcome.
Measured: 6 months
Pittsburgh Sleep Quality Index (PSQI)
The last key secondary objective is an assessment of exploratory outcomes, including the PSQI, a patient-reported outcome.
Measured: 6 months
12-Item Multiple Sclerosis Walking Scale (MSWS-12)
The last key secondary objective is an assessment of exploratory outcomes, including the MSWS-12, a patient-reported outcome.
Measured: 6 months
Center for Epidemiological Studies Depression Scale (CESD)
The last key secondary objective is an assessment of exploratory outcomes, including the CESD, a patient-reported outcome.
Measured: 6 months
Modified Fatigue Impact Score (MFIS)
The last key secondary objective is an assessment of exploratory outcomes, including the MFIS, a patient-reported outcome.
Measured: 6 months
36-Item Short Form Survey (SF36)
The last key secondary objective is an assessment of exploratory outcomes, including the SF36, a patient-reported outcome. , Visual Function Questionnaire (VFQ25); other MRI metrics, including total volume of T2 lesions, number of new/enlarging T2 lesions, atrophy in corpus callosum, thalamus, prefrontal cortex, and other exploratory structures; Timed Up and Go test; and FitBit measures of variability in step count.
Measured: 6 months
Visual Function Questionnaire (VFQ25)
The last key secondary objective is an assessment of exploratory outcomes, including the VFQ25, a patient-reported outcome.
Measured: 6 months
Total T2 Lesion Volume
The last key secondary objective is an assessment of exploratory outcomes, including total volume of T2 lesions.
Measured: 6 months
Number of New/Enlarging T2 Lesions
The last key secondary objective is an assessment of exploratory outcomes, including the number of new/enlarging T2 lesions.
Measured: 6 months
Levels of Brain Atrophy
The last key secondary objective is an assessment of exploratory outcomes, including levels of atrophy in the corpus callosum, thalamus, prefrontal cortex, and other exploratory structures.
Measured: 6 months
Timed Up and Go (TUG) test
The last key secondary objective is an assessment of exploratory outcomes, including the TUG test.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start10 Sep 2019
- Primary completion13 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, placebo controlled, double-blind, delayed-start trial of BZA in 50 women with MS to be given as follows: Group A will receive 3 months of BZA + 3 months of BZA; Group B will receive 3 months of placebo + 3 months of BZA
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riley Bove, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Riley Bove, MD, University of California, San Francisco
- Investigators
- Riley M Bove, MD MMSc, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002934
- Sponsor's protocol ID
- ReWRAP
- Other IDs
- 138495, 18-24511
- Acronym
- ReWRAP
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2019
- Last updated
- 8 Jun 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29029896Nylander A, Anderson A, Rowles W, Hsu S, Lazar AA, Mayoral SR, Pease-Raissi SE, Green A, Bove R. Re-WRAP (Remyelination for women at risk of axonal loss and progression): A phase II randomized placebo-controlled delayed-start trial of bazedoxifene for myelin repair in multiple sclerosis. Contemp Clin Trials. 2023 Nov;134:107333. doi: 10.1016/j.cct.2023.107333. Epub 2023 Sep 20.
PubMed 37739167Morales-Rodriguez D, Anderson A, Nylander A, Hsu S, Singh J, Rowles W, Walsh CM, Braley TJ, Bove R. Well-being at midlife: Correlates of mental health in ambulatory menopausal women with multiple sclerosis. Mult Scler. 2023 Oct;29(11-12):1493-1502. doi: 10.1177/13524585231197056. Epub 2023 Sep 16.
PubMed 37715710
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04002934
- Acronym / sponsor ID
- ReWRAP / ReWRAP
- Keywords
- MS, RRMS, Remyelination, Repair, Multiple Sclerosis, SERM, Estrogen, BZA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Riley Bove, MDUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Multiple Sclerosis (MS) is a chronic neurologic disorder characterized by the loss of myelin, which results in disruption of nerve signal, damage to axons, and, ultimately, neurodegeneration. In order to treat MS, new methods for promoting repair (remyelination) are sorely needed.
There is a strong preclinical (including EAE) and epidemiologic rationale for investigating the remyelinating potential of estrogenic compounds, including evidence of endogenous (puberty, postpartum periods) and exogenous hormonal influences on MS risk and course. MS affects 3 times more women than men, and disease course in women appears overall less aggressive (on MRI, fewer T2-hyperintense demyelinated lesions develop into axonal destruction visualized as hypointense T1 "black holes").
Bazedoxifene (BZA), a third-generation SERM with extensive safety data in humans, was identified in a novel high-throughput screen (BIMA screen) for compounds capable of promoting remyelination. Subsequent analysis validated BZA's remyelinating effect in vitro and in vivo following demyelinating insult. Given strong pre-clinical support for BZA's remyelinating potential, and the clinical success of other compounds identified using the BIMA screen (Green et al., 2017), the investigators will investigate the use of BZA as a remyelinating therapy in patients with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, placebo controlled, double-blind, delayed-start trial of BZA in 50 women with MS to be given as follows: Group A will receive 3 months of BZA + 3 months of BZA; Group B will receive 3 months of placebo + 3 months of BZA
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Bazedoxifene AcetateGroup 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 |
| Group B | Experimental | Drug: Bazedoxifene AcetateGroup 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 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bazedoxifene AcetateAlso: Bazedoxifene, Conbriza, Viviant, TSE-42440 mg Bazedoxifene delivered orally in the form of 2x 20 mg blinded capsules | Drug | Group A, Group B |
Primary outcome
Myelin Water Fraction (MWF) on MRI
Time frame: 3 months
The primary objective is to evaluate the efficacy of BZA relative to placebo for increasing MWF on MRI within normal appearing white matter of the corpus callosum, between baseline and 90 days in a double-blinded trial (1st 90 days in the early start group versus 1st 90 days of the delayed start group).
23 secondary outcomes
Changes in BICAMS scores
Time frame: 3 months
Changes in MSFC scores
Time frame: 3 months
Changes in BICAMS scores
Time frame: 6 months
Changes in MSFC scores
Time frame: 6 months
Myelin Water Fraction (MWF) on MRI
Time frame: 6 months
Visual Evoked Potential (VEP) P100 Latency
Time frame: 3 months
Visual Evoked Potential (VEP) P100 Latency
Time frame: 6 months
Novel Digital Measures of Cognition
Time frame: 6 months
FitBit Activity
Time frame: 6 months
Serum Neurofilament Light Chain (NFL) levels
Time frame: 6 months
Expanded Disability Status Scale (EDSS)
Time frame: 6 months
Bladder Control Scale (BLCS)
Time frame: 6 months
Bowel Control Scale (BWCS)
Time frame: 6 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 months
12-Item Multiple Sclerosis Walking Scale (MSWS-12)
Time frame: 6 months
Center for Epidemiological Studies Depression Scale (CESD)
Time frame: 6 months
Modified Fatigue Impact Score (MFIS)
Time frame: 6 months
36-Item Short Form Survey (SF36)
Time frame: 6 months
Visual Function Questionnaire (VFQ25)
Time frame: 6 months
Total T2 Lesion Volume
Time frame: 6 months
Number of New/Enlarging T2 Lesions
Time frame: 6 months
Levels of Brain Atrophy
Time frame: 6 months
Timed Up and Go (TUG) test
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Background: PubMed 29029896Green 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.
- Derived from this study: PubMed 37739167Nylander A, Anderson A, Rowles W, Hsu S, Lazar AA, Mayoral SR, Pease-Raissi SE, Green A, Bove R. Re-WRAP (Remyelination for women at risk of axonal loss and progression): A phase II randomized placebo-controlled delayed-start trial of bazedoxifene for myelin repair in multiple sclerosis. Contemp Clin Trials. 2023 Nov;134:107333. doi: 10.1016/j.cct.2023.107333. Epub 2023 Sep 20.
- Derived from this study: PubMed 37715710Morales-Rodriguez D, Anderson A, Nylander A, Hsu S, Singh J, Rowles W, Walsh CM, Braley TJ, Bove R. Well-being at midlife: Correlates of mental health in ambulatory menopausal women with multiple sclerosis. Mult Scler. 2023 Oct;29(11-12):1493-1502. doi: 10.1177/13524585231197056. Epub 2023 Sep 16.
- Bove LabLink provided by the sponsor.
- UCSF HealthLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riley M Bove, MD MMSc principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bazedoxifene Acetate in people with Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Riley Bove, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myelin Water Fraction (MWF) on MRI (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04002934, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025; AzTrials last refreshed its copy on 26 Oct 2026.