Relapsing Remitting Multiple SclerosisPhase 2NCT01037907
A Study of Orally Administered BGC20-0134 (Structured Lipid) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
A Phase 2 study testing Pleneva TM BGC20-0134 in people with Relapsing Remitting Multiple Sclerosis, run by Boston Scientific Corporation at 35 sites in 6 countries.
Trial summary
To determine the efficacy and safety of an oral drug (BGC20-0134) in patients with relapsing remitting multiple sclerosis. Specifically, the cumulative number of new gadolinium enhancing lesions after 24 weeks of treatment with BGC20-0134. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Pleneva TM BGC20-0134
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 173 participants
- Where
- 35 sitesin 6 countries
- Study dates
- Nov 2009to Dec 2011
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of relapsing MS according to the revised 2005 McDonald criteria
- Has shown disease activity defined by 1 or more MS attack within the last year which has been documented in prior medical notes and or the presence of active lesions on historical scans being either (based on radiology report or investigator review of MRI):
- Gd-enhancing on any scan obtained in the last year, or
- new T2 lesions between two scans both obtained within the last year
- A minimum total of 9 T2 lesions reported on a recent MRI obtained within 1 month prior to the screening visit
- Baseline EDSS score 0 - 5.5
- Has refused to be treated with approved disease modifying therapies available for MS, for any reason and once the investigator has fully informed the patient about the related benefits and potential adverse events associated with such treatments. Also, patients for whom such treatments have proved to be intolerable
Who cannot join
- Has experienced an MS relapse or received systemic corticosteroids or adrenocorticotropic hormone (ACTH) in the previous 1 month
- Has a secondary progressive (SPMS), progressive relapsing (PRMS), or primary progressive MS (PPMS).
- Has received any of the following agents to treat MS (approved or unapproved):
- Within the previous 3 months: interferon beta, glatiramer acetate, intravenous immunoglobulin or plasmapheresis
- Within the previous 12 months: natalizumab, daclizumab, cytapheresis, azathioprine, cladribine, cyclophosphamide, methotrexate, mitoxantrone, mycophenolate, pixantrone, sirolimus, tacrolimus, or other agents typically used to prevent transplant rejection or as cancer chemotherapy, excluding hormonal treatments
- Ever having received: stem cell or bone marrow transplant, total lymphoid irradiation, vaccine therapy for MS, or monoclonal antibodies whose effects may be longer than 1 year (such as alemtuzumab or rituximab)
- Within the previous 3 months: any other agents given for the non-symptomatic treatment of MS which are not included above, including over-the-counter, herbal and nutritional supplements. However, if the agent is being taken primarily to treat another medical condition, then it is allowed as long as the dose is unchanged within the previous 3 months and is unlikely to change before week 24.
Trial locations and contacts
35 sites in 6 countries.
35 sites in 6 countries
Germany11 sites
Klnik Hohe Warte
Bayreuth, D-95445
Jüdisches Krankenhaus Berlin
Berlin
Universitätsklinikum Charité, Campus Mitte
Berlin
Klinikum der Ruhr-Universität Bochum
Bochum
Universitätsklinikum der Heinrich-Heine-Universität Düsseldorf
Düsseldorf
Universitätsklinikum Essen
Essen
Universitätsklinikum Magdeburg A.ö.R
Magdeburg, 39120
Klinikum Osnabrück Klinik für Neurologie
Osnabrück, 49076
Universitätsklinikum Rostock AöR
Rostock, 18147
Neurologische und psychiatrische Praxis
Stuttgart, 70191
Universitätsklinikum Ulm
Ulm
Spain7 sites
Hospital Universitari Germans Trias i Pujol
Badalona
Hospital Clinic de Barcelona
Barcelona
Vall'd Hebron
Barcelona
Hospital Universitari de Girona
Girona, Avda.De Franca, S/n, 17007
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario Ntra Sra de la Candelaria
Santa Cruz de Tenerife, 38010
Russia6 sites
City hospital # 11 Str. Dvintcev 6
Moscow
Moscow regional institute of clinical research named after M.F. Vladimirsky
Moscow
State Medical University named after I.P. Pavlov
Saint Petersburg, Str. L. Tolstogo 6/8, 197022
Institute of Human Brain, str. Acad. Pavlov, St-Petersburg
Saint Petersburg
City hospital # 9 Str. B. Gornaya 43, Saratov
Saratov
hospital # 33 pr. Lenina 54, Nizniy Novgorod
Velikiy Novgorod
France4 sites
CHU Amiens-Hôpital Nord-
Amiens
CHU Clermont Ferrand-Hôpital Gabriel Montpied-
Clermont
CHRU Strasbourg- Hôpital Civil-1 place de l'hôpital
Strasbourg
CHU Toulouse-Hôpital Purpan
Toulouse
Poland4 sites
Medical University of Gdansk Ul. Nowe Ogrody 1-6
Gdansk
Upper Silezian Medical Center SAM Ul Ziolowa 45/47
Katowice
Medical University of Lodz
Lodz
Samodzielny Publiczny Szpital Kliniczny
Lublin, 20-954
Belgium3 sites
University Hospital Gent
Ghent
AZ St. Jan Brugge Oostende AV.
Ruddershove
AZ ALMA
Sijsele
About this study
Official title: A Placebo-controlled Phase IIa Study of Orally Administered BGC20-0134/Pleneva TM (Structured Lipid) in Patients With RRMS
To determine the efficacy and safety of an oral drug (BGC20-0134) in patients with relapsing remitting multiple sclerosis. Specifically, the cumulative number of new gadolinium enhancing lesions after 24 weeks of treatment with BGC20-0134.
Read the detailed description
Primary outcome measure:
The cumulative number of new GdE T1 lesions developing while on treatment.
Secondary outcome measures:
- MRI:
- Cumulative number of total GdE T1 lesions developing while on treatment
- Cumulative number of new T2 lesions
- Patients free of GdE (T1-weighted) lesions at week 24
- Change in volume of GdE T1
- Brain atrophy
- Cumulative number of new T1 hypointense lesions (black holes)
- Disease burden, T1 and T2 lesion activity at week 48.
- Number of clinical relapses from baseline to the end of treatment. • Change on the Expanded Disability Status Scale (EDSS)
- Number of patients requiring methylprednisolone treatment for a relapse.
- Serum levels of pro- and anti-inflammatory cytokines.
- Quality of life (MSQOL-54)
Eligibility Criteria
MS-Related inclusion criteria
- Diagnosis of relapsing MS according to the revised 2005 McDonald criteria.
- Has shown disease activity defined by 1 or more MS attack within the last year which has been documented in prior medical notes and or the presence of active lesions on historical scans being either (based on radiology report or investigator review of MRI):
- Gd-enhancing on any scan obtained in the last year, or
- new T2 lesions between two scans both obtained within the last year.
- A minimum total of 9 T2 lesions reported on a recent MRI obtained within 1 month prior to the screening visit.
- Baseline EDSS score 0 - 5.5.
- Has refused to be treated with approved disease modifying therapies available for MS, for any reason and once the investigator has fully informed the patient about the related benefits and potential adverse events associated with such treatments. Also, patients for whom such treatments have proved to be intolerable.
Exclusion Criteria:
- Has experienced an MS relapse or received systemic corticosteroids or adrenocorticotropic hormone (ACTH) in the previous 1 month.
- Has a secondary progressive (SPMS), progressive relapsing (PRMS), or primary progressive MS (PPMS).
- Has received any of the following agents to treat MS (approved or unapproved):
- Within the previous 3 months: interferon beta, glatiramer acetate, intravenous immunoglobulin or plasmapheresis.
- Within the previous 12 months: natalizumab, daclizumab, cytapheresis, azathioprine, cladribine, cyclophosphamide, methotrexate, mitoxantrone, mycophenolate, pixantrone, sirolimus, tacrolimus, or other agents typically used to prevent transplant rejection or as cancer chemotherapy, excluding hormonal treatments.
- Ever having received: stem cell or bone marrow transplant, total lymphoid irradiation, vaccine therapy for MS, or monoclonal antibodies whose effects may be longer than 1 year (such as alemtuzumab or rituximab).
- Within the previous 3 months: any other agents given for the non-symptomatic treatment of MS which are not included above, including over-the-counter, herbal and nutritional supplements. However, if the agent is being taken primarily to treat another medical condition, then it is allowed as long as the dose is unchanged within the previous 3 months and is unlikely to change before week
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Pleneva TM BGC20-0134, Placebo
- Keywords
- Oral treatment for MS, Oral drug for multiple sclerosis, Oral RRMS, Oral relapsing remitting multiple sclerosis, Gamma Linolenic Acid, GLA, Fatty acid, Triglyceride, Structured lipid, MRI, Magnetic resonance imaging, gadolinium enhancing lesions, expanded disability status scale, EDSS, Demyelination, Remyelination, TGFB1, Transforming growth factor beta 1, cytokines, disease modifying therapy
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Demyelinating Diseases, Camurati-Engelmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleneva TM BGC20-0134Drug
Placebo or 5 g dose
PlaceboDrug
Placebo or 5 g dose
| Study group | Role | What they receive |
|---|---|---|
| BGC20-0134 (Pleneva TM) | Experimental | Structured lipid Receives: Drug: Pleneva TM BGC20-0134 |
| Placebo control | Placebo comparator | Placebo - dummy pill Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative number of new gadolinium-enhanced (GdE) T1 weighted lesions developing while on treatment (specifically the sum of new GdE T1 lesions seen on MRI at weeks 12, 16, 20 and 24).
Measured: 24 weeks
Secondary outcomes (15)
Cumulative number of total GdE T1 weighted lesions developing while on treatment
Measured: 24 weeks
Cumulative number of new T2 weighted lesions
Measured: 24 weeks
Patients free of GdE (T1-weighted) lesions
Measured: 24 weeks
Change in volume of GdE T1 weighted lesions
Measured: 24 weeks
Change in volume of T2 lesions
Measured: 24 weeks
Brain atrophy
Measured: 24 weeks
Cumulative number of new T1 hypointense lesions (black holes)
Measured: 24 weeks
Disease burden, T1 and T2 lesion activity at week 48.
Measured: 48 weeks
Number of clinical relapses from baseline during the first 24 weeks.
Measured: 24 weeks
Change on the Expanded Disability Status Scale (EDSS) during the first 24 weeks
Measured: 48 weeks
Number of patients receiving methylprednisolone treatment for a relapse during the first 24 weeks.
Measured: 48 weeks
Serum levels of cytokines during the first 24 weeks.
Measured: 24 weeks
Quality of life (MSQOL-54) assessment
Measured: 48 weeks
PK for determination of circulating levels of BGC20-0134 and plasma concentrations of dihomo-gamma linolenic acid (DHGLA) during the first 24 weeks.
Measured: 24 weeks
Overall safety of BGC20-0134
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037907
- Sponsor's protocol ID
- BGC20-0134-02
- Status last verified
- Jun 2022
- First submitted
- 21 Dec 2009
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled Phase IIa Study of Orally Administered BGC20-0134/Pleneva TM (Structured Lipid) in Patients With RRMS
- ClinicalTrials.gov ID
- NCT01037907
- Acronym / sponsor ID
- BGC20-0134-02
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Oral treatment for MS, Oral drug for multiple sclerosis, Oral RRMS, Oral relapsing remitting multiple sclerosis, Gamma Linolenic Acid, GLA, Fatty acid, Triglyceride
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Dec 2009 (estimated)
- 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.
To determine the efficacy and safety of an oral drug (BGC20-0134) in patients with relapsing remitting multiple sclerosis. Specifically, the cumulative number of new gadolinium enhancing lesions after 24 weeks of treatment with BGC20-0134.
Detailed description
Primary outcome measure:
The cumulative number of new GdE T1 lesions developing while on treatment.
Secondary outcome measures:
- MRI:
- Cumulative number of total GdE T1 lesions developing while on treatment
- Cumulative number of new T2 lesions
- Patients free of GdE (T1-weighted) lesions at week 24
- Change in volume of GdE T1
- Brain atrophy
- Cumulative number of new T1 hypointense lesions (black holes)
- Disease burden, T1 and T2 lesion activity at week 48.
- Number of clinical relapses from baseline to the end of treatment. • Change on the Expanded Disability Status Scale (EDSS)
- Number of patients requiring methylprednisolone treatment for a relapse.
- Serum levels of pro- and anti-inflammatory cytokines.
- Quality of life (MSQOL-54)
Eligibility Criteria
MS-Related inclusion criteria
- Diagnosis of relapsing MS according to the revised 2005 McDonald criteria.
- Has shown disease activity defined by 1 or more MS attack within the last year which has been documented in prior medical notes and or the presence of active lesions on historical scans being either (based on radiology report or investigator review of MRI):
- Gd-enhancing on any scan obtained in the last year, or
- new T2 lesions between two scans both obtained within the last year.
- A minimum total of 9 T2 lesions reported on a recent MRI obtained within 1 month prior to the screening visit.
- Baseline EDSS score 0 - 5.5.
- Has refused to be treated with approved disease modifying therapies available for MS, for any reason and once the investigator has fully informed the patient about the related benefits and potential adverse events associated with such treatments. Also, patients for whom such treatments have proved to be intolerable.
Exclusion Criteria:
- Has experienced an MS relapse or received systemic corticosteroids or adrenocorticotropic hormone (ACTH) in the previous 1 month.
- Has a secondary progressive (SPMS), progressive relapsing (PRMS), or primary progressive MS (PPMS).
- Has received any of the following agents to treat MS (approved or unapproved):
- Within the previous 3 months: interferon beta, glatiramer acetate, intravenous immunoglobulin or plasmapheresis.
- Within the previous 12 months: natalizumab, daclizumab, cytapheresis, azathioprine, cladribine, cyclophosphamide, methotrexate, mitoxantrone, mycophenolate, pixantrone, sirolimus, tacrolimus, or other agents typically used to prevent transplant rejection or as cancer chemotherapy, excluding hormonal treatments.
- Ever having received: stem cell or bone marrow transplant, total lymphoid irradiation, vaccine therapy for MS, or monoclonal antibodies whose effects may be longer than 1 year (such as alemtuzumab or rituximab).
- Within the previous 3 months: any other agents given for the non-symptomatic treatment of MS which are not included above, including over-the-counter, herbal and nutritional supplements. However, if the agent is being taken primarily to treat another medical condition, then it is allowed as long as the dose is unchanged within the previous 3 months and is unlikely to change before week
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BGC20-0134 (Pleneva TM) | Experimental | Drug: Pleneva TM BGC20-0134Structured lipid |
| Placebo control | Placebo comparator | Drug: PlaceboPlacebo - dummy pill |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of relapsing MS according to the revised 2005 McDonald criteria
- Has shown disease activity defined by 1 or more MS attack within the last year which has been documented in prior medical notes and or the presence of active lesions on historical scans being either (based on radiology report or investigator review of MRI):
- Gd-enhancing on any scan obtained in the last year, or
- new T2 lesions between two scans both obtained within the last year
- A minimum total of 9 T2 lesions reported on a recent MRI obtained within 1 month prior to the screening visit
Key exclusion criteria (7 listed)
- Has experienced an MS relapse or received systemic corticosteroids or adrenocorticotropic hormone (ACTH) in the previous 1 month
- Has a secondary progressive (SPMS), progressive relapsing (PRMS), or primary progressive MS (PPMS).
- Has received any of the following agents to treat MS (approved or unapproved):
- Within the previous 3 months: interferon beta, glatiramer acetate, intravenous immunoglobulin or plasmapheresis
- Within the previous 12 months: natalizumab, daclizumab, cytapheresis, azathioprine, cladribine, cyclophosphamide, methotrexate, mitoxantrone, mycophenolate, pixantrone, sirolimus, tacrolimus, or other agents typically used to prevent transplant rejection or as cancer chemotherapy, excluding hormonal treatments
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 |
|---|---|---|
| Pleneva TM BGC20-0134Placebo or 5 g dose | Drug | BGC20-0134 (Pleneva TM) |
| PlaceboPlacebo or 5 g dose | Drug | Placebo control |
Primary outcome
The cumulative number of new gadolinium-enhanced (GdE) T1 weighted lesions developing while on treatment (specifically the sum of new GdE T1 lesions seen on MRI at weeks 12, 16, 20 and 24).
Time frame: 24 weeks
15 secondary outcomes
Cumulative number of total GdE T1 weighted lesions developing while on treatment
Time frame: 24 weeks
Cumulative number of new T2 weighted lesions
Time frame: 24 weeks
Patients free of GdE (T1-weighted) lesions
Time frame: 24 weeks
Change in volume of GdE T1 weighted lesions
Time frame: 24 weeks
Change in volume of T2 lesions
Time frame: 24 weeks
Brain atrophy
Time frame: 24 weeks
Cumulative number of new T1 hypointense lesions (black holes)
Time frame: 24 weeks
Disease burden, T1 and T2 lesion activity at week 48.
Time frame: 48 weeks
Number of clinical relapses from baseline during the first 24 weeks.
Time frame: 24 weeks
Change on the Expanded Disability Status Scale (EDSS) during the first 24 weeks
Time frame: 48 weeks
Number of patients receiving methylprednisolone treatment for a relapse during the first 24 weeks.
Time frame: 48 weeks
Serum levels of cytokines during the first 24 weeks.
Time frame: 24 weeks
Quality of life (MSQOL-54) assessment
Time frame: 48 weeks
PK for determination of circulating levels of BGC20-0134 and plasma concentrations of dihomo-gamma linolenic acid (DHGLA) during the first 24 weeks.
Time frame: 24 weeks
Overall safety of BGC20-0134
Time frame: 48 weeks
Results and safety
The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Sponsor's websiteLink provided by the sponsor.
Related trials for Relapsing Remitting Multiple Sclerosis
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
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.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pleneva TM BGC20-0134 in people with Relapsing Remitting Multiple Sclerosis, run by Boston Scientific Corporation at 35 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. 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: stopped early, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Germany, Spain, Russia, France, Poland and 1 more country. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
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?
The cumulative number of new gadolinium-enhanced (GdE) T1 weighted lesions developing while on treatment (specifically the sum of new GdE T1 lesions seen on MRI at weeks 12, 16, 20 and 24). (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.