MDDPhase 2NCT06828887
Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LV232 Capsules in the Treatment of MDD
A Phase 2 study testing LV232 40mg, LV232 60mg and Escitalopram in people with MDD, run by Vigonvita Life Sciences at 1 site in China.
Trial summary
This multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding Phase II clinical trial aimed to determine the optimal dose of LV232 capsules for treating MDD, evaluate preliminary efficacy and safety, and provide a basis for Phase III trial design and dosing regimen determination. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- MDD
- What is being tested?
- LV232 40mg, LV232 60mg and Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2025to 20 Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand the purpose, content, and potential adverse reactions of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, able to complete the entire trial process as required and comply with the trial regulations;
- Gender unrestricted, at screening: 18 years old ≤ age ≤ 65 years old;
- Meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) diagnostic criteria for depression according to the Mini International Neuropsychiatric Interview (M.I.N.I. 7.0.2), currently experiencing a single or multiple episodes;
- For first-episode patients, the duration of the current depressive episode must be ≥3 months; for recurrent patients, the duration of the current depressive episode must be ≥1 month (each month is counted as 30 days, the same applies below);
- During the screening and baseline periods, the total score on the Montgomery-Asberg Depression Rating Scale (MADRS) must be ≥26, and the Clinical Global Impression-Severity (CGI-S) score must be ≥4;
- At screening and baseline visits, the score on the first item (depressed mood) of the HAMD-17 scale must be ≥2;
- Female or male subjects of childbearing potential agree and commit to using effective contraception from the signing of the informed consent form until 3 months after the last administration of the trial drug.
Who cannot join
- Treatment-resistant depression (failure to respond to an adequate dose and duration of treatment, at least 8 weeks, with two antidepressants of different mechanisms) or failure to respond to an adequate dose and duration of treatment with escitalopram oxalate;
- Meeting the diagnostic criteria for other mental disorders as per DSM-5 (such as schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, generalized anxiety disorder, obsessive-compulsive and related disorders, somatic symptom and related disorders, etc.);
- Meeting the DSM-5 criteria for substance use disorder;
- Organic mental disorders, such as depression caused by hypothyroidism;
- Depression induced by psychoactive substances or non-addictive substances;
- Presence of depressive symptoms due to other diseases or other types of mental disorders;
Show all 25Show fewer
- A reduction of ≥25% in the MADRS score at baseline compared to the screening period;
- Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) and judged by the investigator to be at risk of suicide, or having suicidal behavior within the 6 months prior to screening;
- Presence of severe physical illnesses deemed by the investigator as grounds for exclusion, such as uncontrolled hypertension or severe unstable cardiovascular diseases, severe liver diseases, kidney diseases, blood diseases, endocrine diseases, neurological diseases, etc.;
- Diseases affecting oral drug absorption, such as active bowel disease, partial or complete intestinal obstruction, chronic diarrhea, etc.;
- Active malignancy or a history of malignancy within 5 years prior to screening (except for completely resected and cured squamous cell carcinoma, cervical carcinoma in situ, etc.);
- History of increased intraocular pressure or narrow-angle glaucoma;
- Individuals with allergic constitution, such as those allergic to two or more drugs or known to be allergic to escitalopram oxalate;
- Use of drugs that alter the activity of liver enzymes (CYP2C19 and CYP2D6) within 4 weeks (or 5 half-lives, whichever is longer) prior to randomization (see Appendix 2);
- Previous treatment with vagus nerve stimulation (VNS) and deep brain stimulation (DBS), or modified electroconvulsive therapy (MECT) within 3 months prior to randomization, or systematic psychotherapy (interpersonal therapy, dynamic therapy, cognitive behavioral therapy), transcranial magnetic stimulation (TMS), and light therapy within 1 month prior to randomization, or judged by the investigator to currently require such treatments;
- Systematic antidepressant treatment within 2 weeks prior to randomization (not less than 30 days for fluoxetine), or discontinuation of psychotropic drugs for less than 5 half-lives prior to randomization (except for stable doses of sleep aids received within 4 weeks prior to randomization, including benzodiazepines (limited to estazolam, alprazolam, and oxazepam) and non-benzodiazepines);
- Use of monoamine oxidase inhibitors such as phenelzine, isocarboxazid, tranylcypromine, etc., and linezolid, methylene blue, etc., within 2 weeks prior to randomization;
- Second or third-degree atrioventricular block, long QT syndrome, or QTcF > 450 ms (male)/460 ms (female) on 12-lead ECG at screening;
- Discontinuation of drugs that prolong the QT interval (such as levofloxacin, fluconazole, ondansetron, amiodarone, metronidazole, erythromycin, and haloperidol, etc.) or drugs that may cause QT interval prolongation and induce torsade de pointes (TdP) for less than 5 half-lives at randomization;
- ALT or AST above 2 times the upper limit of normal; creatinine above 1.5 times the upper limit of normal; 2 or more abnormal indicators in thyroid function tests (TSH, FT3, FT4, TT3, or TT4 below 0.9 times the lower limit of normal or above 1.1 times the upper limit of normal) at screening;
- Positive for Treponema pallidum antibody and HIV antibody at screening;
- Substance abuse (including alcohol, drugs, and other psychoactive substances) within 3 months prior to screening;
- Female subjects who are breastfeeding or have a positive pregnancy test at screening or during the trial;
- Participation in any interventional clinical trial and use of investigational drugs or medical devices within 3 months prior to screening, or currently participating in other clinical trials;
- Other factors deemed by the investigator as unsuitable for participation in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center Ethics Committee
Shanghai
Shen yi feng, 021-34773308
About this study
Official title: Multicenter,Randomized,Double-blind,Placebo,Parallel-controlled,Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LV232 Capsules in the Treatment of Major Depressive Disorder (MDD)
This multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding Phase II clinical trial aimed to determine the optimal dose of LV232 capsules for treating MDD, evaluate preliminary efficacy and safety, and provide a basis for Phase III trial design and dosing regimen determination.
Read the detailed description
This study adopts a multicenter, randomized, double-blind, placebo- and active-controlled parallel-group clinical trial design, aiming to evaluate the efficacy and safety of LV232 capsules ( 40 mg, and 60 mg, once daily) in patients with major depressive disorder (MDD).
The trial plans to enroll 400 subjects, stratified by first episode or recurrence of the disease. Participants will be randomized in a 1:1:1:1 ratio into five groups: LV232 capsules 40 mg, 60 mg, placebo, and active control, with 100 subjects in each group. The treatment will be administered once daily for 8 consecutive weeks.
- Conditions
- MDD
- Being tested
- LV232 40mg, LV232 60mg, Escitalopram, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LV232 40mgDrug
Also called Low-dose group
LV232 capsules 2 capsules (20 mg/capsule) + LV232 capsule placebo 1 capsule + escitalopram oxalate tablet placebo 1 tablet
LV232 60mgDrug
Also called High-dose group
LV232 capsules 3 capsules (20 mg/capsule) + escitalopram oxalate tablet placebo 1 tablet
EscitalopramDrug
Also called Active Comparator
LV232 capsule placebo 3 capsule + escitalopram oxalate tablet 1 tablet
PlaceboDrug
Also called Placebo Comparator,
LV232 capsule placebo 3 capsule + escitalopram oxalate tablet placebo 1 tablet
| Study group | Role | What they receive |
|---|---|---|
| LV232 capsules | Experimental | Capsule, 40 mg or 60 mg, administered orally once daily for 8 consecutive weeks Receives: Drug: LV232 40mg; Drug: LV232 60mg |
| Escitalopram | Active comparator | Tablet, 10 mg , administered orally once daily for 8 consecutive weeks Receives: Drug: Escitalopram |
| Placebo | Placebo comparator | Capsule/Tablet, administered orally once daily for 8 consecutive weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Montgomery Asperger Depression Scale (MADRS) score at the end of treatment (week 8)
The MADRS is a clinician-rated scale used to evaluate depressive symptoms over the preceding week. Participants are assessed on 10 items-including feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest-each scored on a 7-point scale (0 = no symptoms, 6 = maximum severity). The total score ranges from 0 to 60, with higher scores indicating greater depression severity. A negative change in score signifies improvement.
Change = (Week 8 post-dose score - baseline week 0 score). at the end of treatment (week 8)
Measured: Baseline and week 8
Secondary outcomes (13)
Change from baseline in Hamilton Depression Scale (HAMD-17) at week 8
The HAMD-17 is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.
Change = (Week 8 post-dose score - baseline week 0 score).
Measured: Baseline, week 8
Change from baseline in Hamilton Anxiety Inventory (HAMA) scores at week 8
The HAMA is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAMA total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome.
Change = (Week 8 post-dose score - baseline week 0 score).
Measured: Baseline, week 8
Change from baseline in CGI-S score at week 8
The CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment. The CGI-S will provide an overall clinician-determined summary measure that takes into account all available information including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function.
Change = (Week 8 post-dose score - baseline week 0 score).
Measured: Baseline and week 8
CGI-I score at week 8
The CGI-I assesses the subject's improvement (or worsening). The rater is required to assess the subject's condition relative to baseline* on a 7-point scale. In all cases, the assessment should be made independent of whether the rater believes the improvement is study medication-related or not.
Measured: Baseline, week 8
Change from baseline in PHQ-9 score at week 8
The PHQ-9 scale consists of 9 items, each corresponding to a core symptom of depression, including depressed mood, loss of interest, sleep disturbances, fatigue, changes in appetite, feelings of guilt, difficulty concentrating, psychomotor retardation or agitation, and suicidal thoughts. Patients are required to rate each item based on their experiences over the past two weeks, with scores ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms.
Measured: Baseline, week 8
Change from baseline in PDQ-D5 score at week 8
The PDQ-D5 is used to assess cognitive symptoms, describing potential issues that participants may experience with memory, attention, or concentration. Based on their experiences over the past 7 days, participants select the most appropriate option for each item. The scale consists of 5 items, each with 5 response options (scored 0-4). The total score ranges from 0 to 20, with higher scores indicating more severe cognitive symptoms.
Measured: Baseline, week 8
Change from baseline in DSST score at week 8
The DSST (Digit Symbol Substitution Test) is used to assess processing speed, attention, and visuomotor coordination. Based on a digit-symbol coding key where each number 1-9 corresponds to a unique symbol, participants match as many symbols to their corresponding numbers as possible within 90 seconds. Higher scores indicate better cognitive function.
Measured: Baseline and week 8
Change from baseline in SHAPPS score at week 8
The SHAPS (Snaith-Hamilton Pleasure Scale) consists of 14 items assessing hedonic responses to common daily life situations, including but not limited to eating, hobbies/recreational activities, and other typical sources of pleasure.
Measured: Baseline and week 8
SMQD score at week 8
The Somatic Symptoms Questionnaire for Mental Disorders (SQMD) is a self-rated assessment tool primarily designed to evaluate the severity of common somatic symptoms associated with psychiatric disorders-including depressive disorders, bipolar disorders, anxiety disorders, and somatic symptom disorders-over the past week.
Measured: Baseline and week 8
MARS score at week 8
The Medication Satisfaction Rating Scale (MSRS) is a self-rated questionnaire designed to assess patients' satisfaction levels with their current medication regimen.
Measured: week 8
Change from baseline in ASEX score at week 8
The Arizona Sexual Experience Scale (ASEX) is a 5-item rating scale where each item is scored from 1 (hyperfunction) to 6 (hypofunction), with gender-specific versions (male and female) tailored to the assessed individual.
Measured: Baseline and week 8
Change from baseline in C-SSRS score at week 8
The Columbia Suicide Severity Rating Scale (C-SSRS) is a standardized clinical instrument specifically designed for the assessment of suicide risk.
Measured: Baseline and week 8
Incidence of adverse events (AE)
The AEs will be assessed according to the National Cancer Institute (NCI) CTCAE v5.0.
Measured: Throughout the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start3 Apr 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDDStudies of the same condition, open and under way.
- More trials run by Vigonvita Life SciencesThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vigonvita Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Huafang, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828887
- Sponsor's protocol ID
- LV232-MDD-II-01
- Status last verified
- May 2026
- First submitted
- 10 Feb 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter,Randomized,Double-blind,Placebo,Parallel-controlled,Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LV232 Capsules in the Treatment of Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT06828887
- Acronym / sponsor ID
- LV232-MDD-II-01
- Conditions
- MDD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Vigonvita Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 17 Feb 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.
This multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding Phase II clinical trial aimed to determine the optimal dose of LV232 capsules for treating MDD, evaluate preliminary efficacy and safety, and provide a basis for Phase III trial design and dosing regimen determination.
Detailed description
This study adopts a multicenter, randomized, double-blind, placebo- and active-controlled parallel-group clinical trial design, aiming to evaluate the efficacy and safety of LV232 capsules ( 40 mg, and 60 mg, once daily) in patients with major depressive disorder (MDD).
The trial plans to enroll 400 subjects, stratified by first episode or recurrence of the disease. Participants will be randomized in a 1:1:1:1 ratio into five groups: LV232 capsules 40 mg, 60 mg, placebo, and active control, with 100 subjects in each group. The treatment will be administered once daily for 8 consecutive weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LV232 capsules | Experimental | Drug: LV232 40mg, Drug: LV232 60mgCapsule, 40 mg or 60 mg, administered orally once daily for 8 consecutive weeks |
| Escitalopram | Active comparator | Drug: EscitalopramTablet, 10 mg , administered orally once daily for 8 consecutive weeks |
| Placebo | Placebo comparator | Drug: PlaceboCapsule/Tablet, administered orally once daily for 8 consecutive weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Fully understand the purpose, content, and potential adverse reactions of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, able to complete the entire trial process as required and comply with the trial regulations;
- Gender unrestricted, at screening: 18 years old ≤ age ≤ 65 years old;
- Meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) diagnostic criteria for depression according to the Mini International Neuropsychiatric Interview (M.I.N.I. 7.0.2), currently experiencing a single or multiple episodes;
- For first-episode patients, the duration of the current depressive episode must be ≥3 months; for recurrent patients, the duration of the current depressive episode must be ≥1 month (each month is counted as 30 days, the same applies below);
- During the screening and baseline periods, the total score on the Montgomery-Asberg Depression Rating Scale (MADRS) must be ≥26, and the Clinical Global Impression-Severity (CGI-S) score must be ≥4;
Key exclusion criteria (25 listed)
- Treatment-resistant depression (failure to respond to an adequate dose and duration of treatment, at least 8 weeks, with two antidepressants of different mechanisms) or failure to respond to an adequate dose and duration of treatment with escitalopram oxalate;
- Meeting the diagnostic criteria for other mental disorders as per DSM-5 (such as schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, generalized anxiety disorder, obsessive-compulsive and related disorders, somatic symptom and related disorders, etc.);
- Meeting the DSM-5 criteria for substance use disorder;
- Organic mental disorders, such as depression caused by hypothyroidism;
- Depression induced by psychoactive substances or non-addictive substances;
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 |
|---|---|---|
| LV232 40mgAlso: Low-dose groupLV232 capsules 2 capsules (20 mg/capsule) + LV232 capsule placebo 1 capsule + escitalopram oxalate tablet placebo 1 tablet | Drug | LV232 capsules |
| LV232 60mgAlso: High-dose groupLV232 capsules 3 capsules (20 mg/capsule) + escitalopram oxalate tablet placebo 1 tablet | Drug | LV232 capsules |
| EscitalopramAlso: Active ComparatorLV232 capsule placebo 3 capsule + escitalopram oxalate tablet 1 tablet | Drug | Escitalopram |
| PlaceboAlso: Placebo Comparator,LV232 capsule placebo 3 capsule + escitalopram oxalate tablet placebo 1 tablet | Drug | Placebo |
Primary outcome
Change from baseline in Montgomery Asperger Depression Scale (MADRS) score at the end of treatment (week 8)
Time frame: Baseline and week 8
The MADRS is a clinician-rated scale used to evaluate depressive symptoms over the preceding week. Participants are assessed on 10 items-including feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest-each scored on a 7-point scale (0 = no symptoms, 6 = maximum severity). The total score ranges from 0 to 60, with higher scores indicating greater depression severity. A negative change in score signifies improvement. Change = (Week 8 post-dose score - baseline week 0 score). at the end of treatment (week 8)
13 secondary outcomes
Change from baseline in Hamilton Depression Scale (HAMD-17) at week 8
Time frame: Baseline, week 8
Change from baseline in Hamilton Anxiety Inventory (HAMA) scores at week 8
Time frame: Baseline, week 8
Change from baseline in CGI-S score at week 8
Time frame: Baseline and week 8
CGI-I score at week 8
Time frame: Baseline, week 8
Change from baseline in PHQ-9 score at week 8
Time frame: Baseline, week 8
Change from baseline in PDQ-D5 score at week 8
Time frame: Baseline, week 8
Change from baseline in DSST score at week 8
Time frame: Baseline and week 8
Change from baseline in SHAPPS score at week 8
Time frame: Baseline and week 8
SMQD score at week 8
Time frame: Baseline and week 8
MARS score at week 8
Time frame: week 8
Change from baseline in ASEX score at week 8
Time frame: Baseline and week 8
Change from baseline in C-SSRS score at week 8
Time frame: Baseline and week 8
Incidence of adverse events (AE)
Time frame: Throughout the study period
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 20 Oct 2026.
- 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.
Li Huafang principal investigator
Shanghai Mental Health Center
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 LV232 40mg, LV232 60mg and Escitalopram in people with MDD, run by Vigonvita Life Sciences at 1 site in China.
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 25 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 20 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 1 site in China. 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 Duan Huaqing (+86-18061926005, huaqing.duan@vigonvita.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Montgomery Asperger Depression Scale (MADRS) score at the end of treatment (week 8) (time frame: Baseline and week 8). 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 20 Oct 2026.