Multiple Sclerosis SpasticityPhase 2MSSNCT06782490
A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity
A Phase 2 study testing BMS-986368 in people with Multiple Sclerosis Spasticity, run by Celgene at 61 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis Spasticity
- What is being tested?
- BMS-986368
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 61 sitesin 7 countries
- Study dates
- 5 Jun 2025to 9 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have a multiple sclerosis (MS) diagnosis.
- Participants must have a history of spasticity due to MS for at least 6 months prior to Visit 1.
- Participants must have a Modified Ashworth Scale (mAS) score ≥2 in each of 2 muscle groups (at least one muscle group in the leg, excluding ankle plantar flexors) at Visit 1.
- Participants must have an Expanded Disability Status Scale (EDSS) score 3.0-6.5 at Visit 1.
Who cannot join
- Participants must not have any concomitant disease or disorder that has symptoms of spasticity or that may influence the participant's level of spasticity.
- Participants must not have an acute MS exacerbation/relapse requiring treatment or alteration in disease modifying drug dose within 3 months of Visit 1 or Visit 2.
- Participants must not have a history of any substance abuse disorder as defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Diagnostic Criteria for Drug and Alcohol Abuse.
- Participants must not be currently taking a medication for spasticity that cannot be discontinued and washed out by Visit 2.
- Participants must not have used FAAH/MAGL inhibitor medication or any cannabinoid-related products (including cannabis, cannabidiol (CBD), or tetrahydrocannabinol (THC)) within 30 days prior to Visit 1.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
61 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
61 sites in 7 countries
United States17 sites, 15 recruiting
- Withdrawn
Local Institution - 0017
Aurora, Colorado, 80045
- Recruiting
Alabama Neurology Associates
Birmingham, Alabama, 35209
Emily Riser, Site 0033, 205-803-2210
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Shahla Hosseini, Site 0002, 412-427-7087
- Recruiting
Riverside Methodist Hospital
Columbus, Ohio, 43214
Jacqueline Nicholas, Site 0039, 614-566-1255
- Withdrawn
Local Institution - 0069
Columbus, Ohio, 43235
- Not yet recruiting
Local Institution - 0080
Farmington, Michigan, 48334
Site 0080
- Recruiting
Neurology Center of New England
Foxborough, Massachusetts, 02035
Andrew Taylor, Site 0049, 781-551-5812
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Sharon Lynch, Site 0016, 913-588-6980
- Recruiting
EvergreenHealth Medical Center
Kirkland, Washington, 98034
Theodore Brown, Site 0001, 425-899-5385
- Recruiting
Hope Neurology
Knoxville, Tennessee, 37922
Sibyl Wray, Site 0003, 865-218-6222
- Recruiting
Prime Clinical Research
Lewisville, Texas, 75067
Madhavi Thomas, Site 0072, 817-907-7330
- Recruiting
Aqualane Clinical Research
Naples, Florida, 34105
Matthew Baker, Site 0068, 239-529-6780
- Recruiting
Thomas Jefferson University, Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
Thomas Leist, Site 0067, 215-955-6871
- Recruiting
Perseverance Research Center,LLC
Scottsdale, Arizona, 85253
Barry Hendin, Site 0050, 602-258-3368
- Recruiting
Northwest Neurology
Southfield, Michigan, 48034
Tessy Jenkins, Site 0071
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Robert Naismith, Site 0018, 314-362-3293
- Recruiting
USF Health
Tampa, Florida, 33612
Derrick Robertson, Site 0015, 813-974-6378
Poland11 sites, 9 recruiting
- Recruiting
Centrum Medyczne NEUROMED
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-163
Pawel Lisewski, Site 0057, 0048698619497
- Not yet recruiting
Local Institution - 0044
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796
Site 0044
- Withdrawn
Local Institution - 0061
Gdansk, 80-952
- Not yet recruiting
Local Institution - 0079
Katowice, Silesian Voivodeship, 40-081
Site 0079
- Recruiting
M.A. - LEK A.M. Maciejowscy S.C., Centrum Terapii SM
Katowice, 40-571
Katarzyna Maciejowska, Site 0045, 665041418
- Recruiting
Pratia MCM Krakow
Krakow, Lesser Poland Voivodeship, 30-727
Paulina Kaczmarska, Site 0046, +48122954100
- Recruiting
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, 31-503
Agnieszka Slowik, Site 0056, +48607685751
- Not yet recruiting
Local Institution - 0076
Lodz, Łódź Voivodeship, 90-368
Site 0076
- Recruiting
Instytut Zdrowia Dr Boczarska Jedynak
Oświęcim, Lesser Poland Voivodeship, 32-600
Magdalena Boczarska-Jedynak, Site 0048, +48-501-485-317
- Withdrawn
Local Institution - 0051
Słomniki, 32-090
- Recruiting
Centrum Medyczne NeuroProtect
Warsaw, Masovian Voivodeship, 01-684
Anna Karlinska, Site 0047, +48660517184
Germany10 sites, 8 recruiting
- Recruiting
Neurozentrum Bielefeld
Bielefeld, 33647
Matthias Böhringer, Site 0051, 0049521443069
- Recruiting
St. Josef und St. Elisabeth Hospital gGmbH
Bochum, North Rhine-Westphalia, 44791
Simon Faissner, Site 0027, +49 234 509-2441
- Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Tjalf Ziemssen, Site 0021, +4917610315216
- Withdrawn
Local Institution - 0020
Essen, 45122
- Recruiting
Universitätsklinikum Jena
Jena, Thuringia, 07747
Matthias Schwab, Site 0023, +4936419323486
- Recruiting
Neurologischen Gemeinschaftspraxis Kassel und Vellmar
Kassel, Hesse, 34121
Christoph Lassek, Site 0022, 004956171611
- Withdrawn
Local Institution - 0031
Meisenheim, Rhineland-Palatinate, 55590
- Recruiting
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, North Rhine-Westphalia, 48149
Luisa Klotz, Site 0060, 00492518348165
- Not yet recruiting
Local Institution - 0078
Siegen, North Rhine-Westphalia, 57076
Site 0078
- Recruiting
Klinikum Würzburg Mitte
Würzburg, Bavaria, 97074
Mathias Mäurer, Site 0052, 00499313935700
Australia8 sites, 8 recruiting
- Recruiting
Box Hill Hospital
Box Hill, Victoria, 3128
Katherine Buzzard, Site 0007, +61 3 9094 9527
- Recruiting
Austin Health
Heidelberg, Victoria, 3084
Marion Simpson, Site 0008, +61 3 94963705
- Recruiting
Menzies Research Institute
Hobart, Tasmania, 7001
Yi Chao Foong, Site 0075, 03 6226 7746
- Recruiting
Centre for Neuroscience Innovation
Kent Town, South Australia, 5067
Andrew Lee, Site 0030, +61 8 81320494
- Recruiting
Perron Institute
Nedlands, Western Australia, 6009
william Carroll, Site 0019, +61 8 6457 0213
- Recruiting
John Hunter Hospital
Newcastle, New South Wales, 2305
Jeannette Lechner-Scott, Site 0005, +61 2 4042 0682
- Recruiting
The Royal Melbourne Hospital
Parkville, Victoria, 3050
Mark Marriott, Site 0006, + 61 3 93429092
- Recruiting
University of Sydney - Brain and Mind Research Institute (BMRI)
Sydney, New South Wales, 2050
Michael Barnett, Site 0004, +61 2 9351 0704
Czechia8 sites, 7 recruiting
- Recruiting
Fakultni Nemocnice u sv. Anny v Brne
Brno, Brno-město, 656 91
Martin Pail, Site 0055, +420 543 182 658
- Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Králové, Hradec Králové, 500 05
Zbyšek Pavelek, Site 0010, +420 495 831 111
- Recruiting
Nemocnice Pardubického kraje
Pardubice, 532 03
Miroslav Mares, Site 0053, +420 466 014 732
- Recruiting
Vseobecna fakultni nemocnice v Praze
Prague, Praha 2, 12111
Ivana Kovářová, Site 0054, +420 224 961 111
- Recruiting
Fakultni Thomayerova nemocnice
Prague, Praha 4, 14059
Marketa Grunermelova, Site 0059, +420 543 182 658
- Withdrawn
Local Institution - 0011
Prague, Praha 5, 150 06
- Recruiting
Nemocnice Teplice
Teplice, Ústí nad Labem Region, 415 01
Marta Vachová, Site 0009, +420 417 519 625
- Not yet recruiting
Local Institution - 0077
Zlín, 762 75
Site 0077
Canada6 sites, 6 recruiting
- Recruiting
University Of Alberta Hospital
Edmonton, Alberta, T6G 2G3
Gregg Blevins, Site 0013, 780-248-5895
- Recruiting
Centre de Recherche Saint-Louis
Lévis, Quebec, G6W0M5
Donald Rivest, Site 0014, 418-780-3501x2703
- Recruiting
University Hospital - London Health Sciences Centre
London, Ontario, N6A 5A5
Juan Racosta, Site 0024, 519 685 8500x35520
- Recruiting
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A2B4
Adil Harroud, Site 0029, (514) 396-2950
- Recruiting
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
Mark Freedman, Site 0012, 613-737-8104
- Recruiting
Unity Health Toronto, St. Michael's Hospital
Toronto, Ontario, M5B 1W8
James Marriott, Site 0028, 416-864-6060 x3450
Puerto Rico1 site, 1 recruiting
- Recruiting
Puerto Rico Multiple Sclerosis Center
Caguas, 00725
Jose Avila Ornelas, Site 0058, 787-930-1705
About this study
Official title: A Phase 2, Randomized, Double-Blind, Four-Arm, Placebo-Controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of Three Doses of Orally Administered BMS-986368, a FAAH/MAGL Inhibitor, for the Treatment of Spasticity in Participants With Multiple Sclerosis (BALANCE-MSS-1)
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity
- Conditions
- Multiple Sclerosis Spasticity
- Being tested
- BMS-986368, Placebo
- Keywords
- Spasticity, Multiple Sclerosis, BMS-986368
- Medical subject headings
- Muscle Spasticity, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986368Drug
Specified dose on specified days
PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Administration of BMS-986368 Dose A | Experimental | Not described Receives: Drug: BMS-986368 |
| Administration of BMS-986368 Dose B | Experimental | Not described Receives: Drug: BMS-986368 |
| Administration of BMS-986368 Dose C | Experimental | Not described Receives: Drug: BMS-986368 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) score
Measured: At week 6
Secondary outcomes (12)
Change from baseline on the Numeric Rating Scale Spasticity (NRS-S) score
Measured: At week 6
Change from baseline on the MS Spasticity Scale (MSSS-88) total scores
Measured: At week 6
Change from baseline on the Timed 25-Foot Walk (T25FW) score
Measured: At week 6
Change from baseline on the Clinical Global Impression of Severity (CGI-S) score
Measured: At week 6
Plasma concentrations of BMS-986368 at selected pre- and post-dose time points
Measured: Up to week 6
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to week 16
Serious adverse events (SAEs)
Measured: Up to week 16
Adverse events (AEs) leading to treatment discontinuation
Measured: Up to week 16
AEs leading to death
Measured: Up to week 16
AEs leading to clinically significant lab abnormalities
Measured: Up to week 16
Number of participants with suicidal ideation and behavior during BMS-986368 administration as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: Up to week 16
Number of participants with withdrawal symptoms following BMS-986368 administration as assessed by the Cannabis Withdrawal Scale (CWS)
Measured: Up to week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start5 Jun 2025
- Primary completion26 May 2027 (estimated)
- Study completion9 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis SpasticityStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782490
- Sponsor's protocol ID
- IM045-1018
- Acronym
- MSS
- Status last verified
- Oct 2026
- First submitted
- 15 Jan 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Four-Arm, Placebo-Controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of Three Doses of Orally Administered BMS-986368, a FAAH/MAGL Inhibitor, for the Treatment of Spasticity in Participants With Multiple Sclerosis (BALANCE-MSS-1)
- ClinicalTrials.gov ID
- NCT06782490
- Acronym / sponsor ID
- MSS / IM045-1018
- Conditions
- Multiple Sclerosis Spasticity
- Keywords
- Spasticity, Multiple Sclerosis, BMS-986368
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 26 May 2027 (estimated)
- Study completion
- 9 Jun 2027 (estimated)
- First posted
- 20 Jan 2025 (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 purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Administration of BMS-986368 Dose A | Experimental | Drug: BMS-986368 |
| Administration of BMS-986368 Dose B | Experimental | Drug: BMS-986368 |
| Administration of BMS-986368 Dose C | Experimental | Drug: BMS-986368 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must have a multiple sclerosis (MS) diagnosis.
- Participants must have a history of spasticity due to MS for at least 6 months prior to Visit 1.
- Participants must have a Modified Ashworth Scale (mAS) score ≥2 in each of 2 muscle groups (at least one muscle group in the leg, excluding ankle plantar flexors) at Visit 1.
- Participants must have an Expanded Disability Status Scale (EDSS) score 3.0-6.5 at Visit 1.
Key exclusion criteria (6 listed)
- Participants must not have any concomitant disease or disorder that has symptoms of spasticity or that may influence the participant's level of spasticity.
- Participants must not have an acute MS exacerbation/relapse requiring treatment or alteration in disease modifying drug dose within 3 months of Visit 1 or Visit 2.
- Participants must not have a history of any substance abuse disorder as defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Diagnostic Criteria for Drug and Alcohol Abuse.
- Participants must not be currently taking a medication for spasticity that cannot be discontinued and washed out by Visit 2.
- Participants must not have used FAAH/MAGL inhibitor medication or any cannabinoid-related products (including cannabis, cannabidiol (CBD), or tetrahydrocannabinol (THC)) within 30 days prior to Visit 1.
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 |
|---|---|---|
| BMS-986368Specified dose on specified days | Drug | Administration of BMS-986368 Dose A, Administration of BMS-986368 Dose B, Administration of BMS-986368 Dose C |
| PlaceboSpecified dose on specified days | Drug | Placebo |
Primary outcome
Change from baseline in Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) score
Time frame: At week 6
12 secondary outcomes
Change from baseline on the Numeric Rating Scale Spasticity (NRS-S) score
Time frame: At week 6
Change from baseline on the MS Spasticity Scale (MSSS-88) total scores
Time frame: At week 6
Change from baseline on the Timed 25-Foot Walk (T25FW) score
Time frame: At week 6
Change from baseline on the Clinical Global Impression of Severity (CGI-S) score
Time frame: At week 6
Plasma concentrations of BMS-986368 at selected pre- and post-dose time points
Time frame: Up to week 6
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to week 16
Serious adverse events (SAEs)
Time frame: Up to week 16
Adverse events (AEs) leading to treatment discontinuation
Time frame: Up to week 16
AEs leading to death
Time frame: Up to week 16
AEs leading to clinically significant lab abnormalities
Time frame: Up to week 16
Number of participants with suicidal ideation and behavior during BMS-986368 administration as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to week 16
Number of participants with withdrawal symptoms following BMS-986368 administration as assessed by the Cannabis Withdrawal Scale (CWS)
Time frame: Up to week 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Related trials for Multiple Sclerosis Spasticity
Not yet recruiting
Evaluating the Effects of the EXOPULSE Suit on Mobility, Walking Ability, and Balance in People With Multiple Sclerosis
Multiple Sclerosis
Recruiting
Repetitive Transcranial Magnetic Stimulation (rTMS) in MS Induced Spastic Paraparesis
Multiple Sclerosis
Active, not recruiting
Evaluation of the Safety and Efficacy of a Full-Body Electrostimulation Garment for Individuals With Neurological and Neuromuscular Conditions That Cause Spasticity, Hyperreflexia, and Pain
Multiple Sclerosis, Fibromyalgia
Recruiting
At Home Use of Stimulation Suits for Managing MS Symptoms
Multiple Sclerosis, MS (Multiple Sclerosis)
Not yet recruiting
Intermittent Theta-Burst Stimulation for Lower-Limb Spasticity and Pain in Multiple Sclerosis
Multiple Sclerosis, Muscle Spasticity
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.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
61 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-986368 in people with Multiple Sclerosis Spasticity, run by Celgene at 61 sites in 7 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Poland, Germany, Australia, Czechia and 2 more countries. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) score (time frame: At week 6). 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 27 Oct 2026.