Spinal Cord InjuryPhase 2/3NCT07625332
Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)
A Phase 2/3 study testing Galantamine Hydrobromide Extended Release in people with Spinal Cord Injury and Traumatic Spinal Cord Injury, run by Northwell Health at 3 sites in United States.
Trial summary
The purpose of this research study is to measure the tolerability and preliminary efficacy of a drug, galantamine, to treat metabolic syndrome (MetS) by reducing circulating inflammation in people with spinal cord injury (SCI). Galantamine is FDA-approved for the treatment of Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Spinal Cord Injury, Traumatic Spinal Cord Injury, Paraplegia and Tetraplegia
- What is being tested?
- Galantamine Hydrobromide Extended Release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Oct 2026to Dec 2027
- Phase
- Phase 2/3
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 21-75 years (male or female)
- Chronic (≥1 year post injury) traumatic non-progressive spinal cord injury (SCI)
- Wheelchair user for community mobility
- Injury level of tetraplegia (cervical level) or paraplegia (all levels)
- SCI-specific obesity indicated by waist circumference ≥94 cm
- Resting heart rate >45 bpm based on 10 measurements over 10 minutes
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- Without clinically significant cardiovascular abnormalities as indicated by 12-lead ECG
- Tolerable bowel routine indicated by a score of <10 on the International SCI Bowel Function Data Set (ISCI-BDS)
- Metabolic Syndrome (MetS) defined by the presence of at least three of the following: (1) obesity indicated by SCI-specific waist circumference ≥94 cm, (2) elevated fasting glucose ≥100 mg/dL, (3) dyslipidemia: high triglycerides ≥150 mg/dL or low HDL cholesterol <40 mg/dL for men and <50 mg/dL for women, (4) C-reactive protein (CRP) levels >1 mg/dL
- Able to understand and communicate in English at the level of describing adverse event frequency and severity and completing validated outcome measures
- Willingness to comply with all study procedures and availability for the duration of the study
- Provision of signed and dated informed consent form
Who cannot join
- Diagnosis of neurological injury or condition other than SCI
- Progressive condition that would be expected to change neurological status
- Signs and symptoms of cardiovascular disease or cardiac arrhythmias
- Resting heart rate <45 bpm
- Score of 10 or greater on the ISCI-BDS v2.1 indicating moderate to severe neurogenic bowel dysfunction
- Severe concurrent medical disease, condition, or illness judged to be contraindicated by the site physician
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- Psychopathology documented in the medical record or history that may conflict with study objectives
- Pregnancy (participant reported or determined by clinical lab test), women who plan to become pregnant, or women who are nursing during the study
- Active cancer or currently in treatment for cancer
- Triglyceride levels ≥400 mg/dL
- Chronic use of medications with known or probable interactions with galantamine
- Enrolled in another research study that is likely to interfere with conduct or results of the current study
- Any other reason the site physician feels that participation is contraindicated
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Northwell Health
Manhasset, New York, 11030
Welmi Pello, MPH, RN, 516-562-1331, wpello@northwell.edu
Joy Cambe, MD, MPH, 516-562-1331, jcambe@northwell.edu
- Recruiting
James J. Peters VA Medical Center
The Bronx, New York, 10468
Dylan Arnero, MA, 718-584-9000 ext. 3128, Dylan.Arnero@va.gov
Genevieve Curtis, 718-584-9000 ext. 3123, Genevieve.Curtis@va.gov
- Not yet recruiting
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052
Trevor Dyson-Hudson, MD, 917-838-3143, tdysonhudson@kesslerfoundation.org
Matthew Maher, MS, 718-584-9000 ext. 1706, Matthew.Maher@va.gov
About this study
Official title: Pilot Study of Tolerability and Preliminary Efficacy of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)
The purpose of this research study is to measure the tolerability and preliminary efficacy of a drug, galantamine, to treat metabolic syndrome (MetS) by reducing circulating inflammation in people with spinal cord injury (SCI). Galantamine is FDA-approved for the treatment of Alzheimer's disease. Here, the drug is considered experimental for the purposes of this study.
- Conditions
- Spinal Cord Injury, Traumatic Spinal Cord Injury, Paraplegia and Tetraplegia, Metabolic Syndrome
- Being tested
- Galantamine Hydrobromide Extended Release
- Keywords
- spinal cord injury, tetraplegia, paraplegia, metabolic syndrome
- Medical subject headings
- Spinal Cord Injuries, Paraplegia, Quadriplegia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galantamine Hydrobromide Extended ReleaseDrug
Also called Razadyne ER
Galantamine hydrobromide extended release (ER) capsules, 8mg, administered orally once daily in the morning with a meal. Aim 1: Single 8mg dose in the laboratory with at least 5 hours of observation. Aim 2: 8mg once daily for Weeks 1-4; dose escalated to 16mg once daily (two 8mg capsules) for Weeks 5-12 based on tolerability. If the 16mg dose is not tolerated, the participant returns to 8mg daily. Total treatment duration: 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Galantamine ER | Experimental | All participants (tetraplegia and paraplegia cohorts) receive galantamine hydrobromide extended release (ER) capsules. Aim 1 (Day 1): single 8mg dose administered orally in the laboratory with at least 5 hours of monitored observation. Aim 2 (Weeks 1-12): 8mg once daily for Weeks 1-4, with dose escalation to 16mg (two 8mg capsules) once daily for Weeks 5-12 based on tolerability. Taken orally in the morning with a meal. The two cohorts (tetraplegia and paraplegia) are analyzed separately as pre-specified subgroups. Receives: Drug: Galantamine Hydrobromide Extended Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ISCI-BDS Neurogenic Bowel Symptoms Score (Aim 1 and Aim 2)
Neurogenic bowel symptoms assessed using the International SCI Bowel Function Data Set (ISCI-BDS). Worsening will be defined as a negative change in ISCI-BDS score category (e.g., mild to moderate).
Measured: Visit 0 (Screening) through Visit 5 (Week 12)
Change in Heart Rate (Avg) During In-Lab Observation (Aim 1)
Heart rate (beats per minute) measured before administration of galantamine 8mgER and at 15-minute intervals during the in-lab observation period.
Measured: Visit 1 (Day 1; pre-dose through 5 hours post-dose)
Change in Blood Pressure During In-Lab Observation (Aim 1)
Blood pressure (mmHg) measured in the seated position before administration of galantamine 8mgER and at 15-minute intervals during the in-lab observation period.
Measured: Visit 1 (Day 1; pre-dose through 5 hours post-dose)
Occurrence of Adverse Events During In-Lab Observation (Aim 1)
Frequency and severity of all adverse events (AEs) during the in-lab observation period after a single dose of galantamine 8mgER, assessed by standardized AE survey and open-ended questions. AEs are graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number of participants experiencing at least one AE will be reported.
Measured: Visit 1 (Day 1; pre-dose through 5 hours post-dose)
Change in Heart Rate (Avg) During Outpatient Treatment (Aim 2)
Heart rate (beats per minute) measured at each study visit and daily at home.
Measured: Visit 2 (Day 2) through Visit 5 (Week 12)
Change in Blood Pressure During Outpatient Treatment (Aim 2)
Blood pressure (mmHg) will be measured at each study visit and daily at home
Measured: Visit 2 (Day 2) through Visit 5 (Week 12)
Occurrence of Adverse Events During Outpatient Treatment (Aim 2)
Frequency and severity of all adverse events (AEs) during the 12-week outpatient dose escalation period, assessed at each study visit and via weekly phone calls. AEs are graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 by severity and relationship to study drug. The number of participants experiencing at least one AE will be reported.
Measured: Visit 2 (Day 2) through Visit 5 (Week 12)
Secondary outcomes (12)
Change in Inflammatory Cytokines During Outpatient Treatment (Aim 2)
Inflammatory markers such as: TNF-α, IL-1ß, IL-6, IL-10, and other cytokines (pg/ml) will be measured in plasma at Visit 2 (Day 2) and Visit 5 (Week 12)
Measured: Visit 2 (Day 2) and Visit 5 (Week 12)
Change in Plasma Leptin During Outpatient Treatment (Aim 2)
Plasma leptin levels measured (pg/ml) at Visit 2 (Day 2) and Visit 5 (Week 12)
Measured: Visit 2 (Day 2) and Visit 5 (Week 12)
Change in Plasma Adiponectin During Outpatient Treatment (Aim 2)
Plasma adiponectin levels (µg/mL) measured at Visit 2 (Day 2) and Visit 5 (Week 12)
Measured: Visit 2 (Day 2) and Visit 5 (Week 12)
Change in Lipids (HDL, LDL, and Triglycerides)
High-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides (mg/dL) will be measured at Visit 0 (Screening) and Visit 5 (Week 12)
Measured: Visit 0 (Screening) and Visit 5 (Week 12)
Change in Fasting Plasma Insulin
Fasting plasma insulin levels (µIU/mL) measured at Visit 0 (Screening) and Visit 5 (Week 12)
Measured: Visit 0 (Screening) and Visit 5 (Week 12)
Change in Fasting Blood Glucose
Fasting blood glucose levels (mg/dL) measured at Visit 0 (Screening) and Visit 5 (Week 12)
Measured: Visit 0 (Screening) and Visit 5 (Week 12)
Change in HOMA-IR From Screening (Aim 2)
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) calculated from fasting glucose and fasting insulin (Unitless index ) at Visit 0 (Screening) and Visit 5 (Week 12)
Measured: Visit 0 (Screening) and Visit 5 (Week 12)
Change in HbA1c From Screening
Hemoglobin A1c (HbA1c) levels (%) measured at Visit 0 (Screening) and Visit 5 (Week 12)
Measured: Visit 0 (Screening) and Visit 5 (Week 12)
Change in C-Reactive Protein (CRP)
C-reactive protein (CRP) levels (mg/L ) measured at Visit 0 (Screening) and Visit 5 (Week 12)
Measured: Visit 0 (Screening) and Visit 5 (Week 12)
Change in Body Composition by DXA During Outpatient Treatment (Aim 2)
Total body fat mass (kg) and total body fat percentage measured by dual-energy X-ray absorptiometry (DXA) total body scan at Visit 2 (Day 2) and Visit 5 (Week 12)
Measured: Visit 2 (Day 2) and Visit 5 (Week 12)
Change in Waist and Hip Circumference During Outpatient Treatment (Aim 2)
Waist and Hip circumference (cm) measured by tape measure at Day 2 and at Week 12.
Measured: Visit 2 (Day 2) and Visit 5 (Week 12)
Change in High Frequency Heart Rate Variability (HF-HRV) During Outpatient Treatment (Aim 2)
High frequency component of heart rate variability (HF-HRV), a valid estimate of cardio-vagal tone (ms²) measured during supine and seated observations Visit 2 (Day 2), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)
Measured: Visit 2 (Day 2), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start15 Oct 2026
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an exploratory, three-site, parallel group, open-label study to evaluate tolerability and preliminary efficacy of galantamine to treat MetS via reduction of systemic inflammation in people with chronic SCI (tetraplegia or paraplegia). Participants with tetraplegia or paraplegia will be analyzed separately as independent groups.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Bronx Veterans Medical Research Foundation, Inc, Kessler Institute for Rehabilitation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625332
- Sponsor's protocol ID
- 25-0846
- Other IDs
- C41213GM, 1349754
- Status last verified
- Oct 2026
- First submitted
- 19 May 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data must be de-identified in accordance with institutional, local, state, and federal guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Tolerability and Preliminary Efficacy of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT07625332
- Acronym / sponsor ID
- 25-0846
- Conditions
- Spinal Cord Injury, Traumatic Spinal Cord Injury, Paraplegia and Tetraplegia, Metabolic Syndrome
- Keywords
- spinal cord injury, tetraplegia, paraplegia, metabolic syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Bronx Veterans Medical Research Foundation, Inc, Kessler Institute for Rehabilitation
- Study start
- 15 Oct 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Jun 2026 (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 research study is to measure the tolerability and preliminary efficacy of a drug, galantamine, to treat metabolic syndrome (MetS) by reducing circulating inflammation in people with spinal cord injury (SCI). Galantamine is FDA-approved for the treatment of Alzheimer's disease. Here, the drug is considered experimental for the purposes of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an exploratory, three-site, parallel group, open-label study to evaluate tolerability and preliminary efficacy of galantamine to treat MetS via reduction of systemic inflammation in people with chronic SCI (tetraplegia or paraplegia). Participants with tetraplegia or paraplegia will be analyzed separately as independent groups.
| Arm | Type | Receives |
|---|---|---|
| Galantamine ER | Experimental | Drug: Galantamine Hydrobromide Extended ReleaseAll participants (tetraplegia and paraplegia cohorts) receive galantamine hydrobromide extended release (ER) capsules. Aim 1 (Day 1): single 8mg dose administered orally in the laboratory with at least 5 hours of monitored observation. Aim 2 (Weeks 1-12): 8mg once daily for Weeks 1-4, with dose escalation to 16mg (two 8mg capsules) once daily for Weeks 5-12 based on tolerability. Taken orally in the morning with a meal. The two cohorts (tetraplegia and paraplegia) are analyzed separately as pre-specified subgroups. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adults aged 21-75 years (male or female)
- Chronic (≥1 year post injury) traumatic non-progressive spinal cord injury (SCI)
- Wheelchair user for community mobility
- Injury level of tetraplegia (cervical level) or paraplegia (all levels)
- SCI-specific obesity indicated by waist circumference ≥94 cm
Key exclusion criteria (13 listed)
- Diagnosis of neurological injury or condition other than SCI
- Progressive condition that would be expected to change neurological status
- Signs and symptoms of cardiovascular disease or cardiac arrhythmias
- Resting heart rate <45 bpm
- Score of 10 or greater on the ISCI-BDS v2.1 indicating moderate to severe neurogenic bowel dysfunction
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 |
|---|---|---|
| Galantamine Hydrobromide Extended ReleaseAlso: Razadyne ERGalantamine hydrobromide extended release (ER) capsules, 8mg, administered orally once daily in the morning with a meal. Aim 1: Single 8mg dose in the laboratory with at least 5 hours of observation. Aim 2: 8mg once daily for Weeks 1-4; dose escalated to 16mg once daily (two 8mg capsules) for Weeks 5-12 based on tolerability. If the 16mg dose is not tolerated, the participant returns to 8mg daily. Total treatment duration: 12 weeks. | Drug | Galantamine ER |
Primary outcome
Change in ISCI-BDS Neurogenic Bowel Symptoms Score (Aim 1 and Aim 2)
Time frame: Visit 0 (Screening) through Visit 5 (Week 12)
Neurogenic bowel symptoms assessed using the International SCI Bowel Function Data Set (ISCI-BDS). Worsening will be defined as a negative change in ISCI-BDS score category (e.g., mild to moderate).
Change in Heart Rate (Avg) During In-Lab Observation (Aim 1)
Time frame: Visit 1 (Day 1; pre-dose through 5 hours post-dose)
Heart rate (beats per minute) measured before administration of galantamine 8mgER and at 15-minute intervals during the in-lab observation period.
Change in Blood Pressure During In-Lab Observation (Aim 1)
Time frame: Visit 1 (Day 1; pre-dose through 5 hours post-dose)
Blood pressure (mmHg) measured in the seated position before administration of galantamine 8mgER and at 15-minute intervals during the in-lab observation period.
Occurrence of Adverse Events During In-Lab Observation (Aim 1)
Time frame: Visit 1 (Day 1; pre-dose through 5 hours post-dose)
Frequency and severity of all adverse events (AEs) during the in-lab observation period after a single dose of galantamine 8mgER, assessed by standardized AE survey and open-ended questions. AEs are graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number of participants experiencing at least one AE will be reported.
Change in Heart Rate (Avg) During Outpatient Treatment (Aim 2)
Time frame: Visit 2 (Day 2) through Visit 5 (Week 12)
Heart rate (beats per minute) measured at each study visit and daily at home.
Change in Blood Pressure During Outpatient Treatment (Aim 2)
Time frame: Visit 2 (Day 2) through Visit 5 (Week 12)
Blood pressure (mmHg) will be measured at each study visit and daily at home
Occurrence of Adverse Events During Outpatient Treatment (Aim 2)
Time frame: Visit 2 (Day 2) through Visit 5 (Week 12)
Frequency and severity of all adverse events (AEs) during the 12-week outpatient dose escalation period, assessed at each study visit and via weekly phone calls. AEs are graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 by severity and relationship to study drug. The number of participants experiencing at least one AE will be reported.
12 secondary outcomes
Change in Inflammatory Cytokines During Outpatient Treatment (Aim 2)
Time frame: Visit 2 (Day 2) and Visit 5 (Week 12)
Change in Plasma Leptin During Outpatient Treatment (Aim 2)
Time frame: Visit 2 (Day 2) and Visit 5 (Week 12)
Change in Plasma Adiponectin During Outpatient Treatment (Aim 2)
Time frame: Visit 2 (Day 2) and Visit 5 (Week 12)
Change in Lipids (HDL, LDL, and Triglycerides)
Time frame: Visit 0 (Screening) and Visit 5 (Week 12)
Change in Fasting Plasma Insulin
Time frame: Visit 0 (Screening) and Visit 5 (Week 12)
Change in Fasting Blood Glucose
Time frame: Visit 0 (Screening) and Visit 5 (Week 12)
Change in HOMA-IR From Screening (Aim 2)
Time frame: Visit 0 (Screening) and Visit 5 (Week 12)
Change in HbA1c From Screening
Time frame: Visit 0 (Screening) and Visit 5 (Week 12)
Change in C-Reactive Protein (CRP)
Time frame: Visit 0 (Screening) and Visit 5 (Week 12)
Change in Body Composition by DXA During Outpatient Treatment (Aim 2)
Time frame: Visit 2 (Day 2) and Visit 5 (Week 12)
Change in Waist and Hip Circumference During Outpatient Treatment (Aim 2)
Time frame: Visit 2 (Day 2) and Visit 5 (Week 12)
Change in High Frequency Heart Rate Variability (HF-HRV) During Outpatient Treatment (Aim 2)
Time frame: Visit 2 (Day 2), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)
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 4 Nov 2026.
- Individual participant dataSharing planned: Undecided. All data must be de-identified in accordance with institutional, local, state, and federal guidelines.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Galantamine Hydrobromide Extended Release in people with Spinal Cord Injury and Traumatic Spinal Cord Injury, run by Northwell Health at 3 sites 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?
The sponsor lists 12 inclusion and 13 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ona Bloom, PhD (516-562-1309, obloom@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ISCI-BDS Neurogenic Bowel Symptoms Score (Aim 1 and Aim 2) (time frame: Visit 0 (Screening) through Visit 5 (Week 12)). The study lists 7 primary outcomes in all. 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 4 Nov 2026.