Major Depressive DisorderPhase 2NCT01098240
A Study Of The Efficacy And Safety Of CP-601,927 Augmentation Of Antidepressant Therapy In Major Depression
A Phase 2 study testing CP-601,927 in people with Major Depressive Disorder, run by Pfizer at 58 sites in United States.
Trial summary
The primary objectives of this study are to: 1) Evaluate the efficacy of CP 601,927 compared to placebo in the augmentation of antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD) using the Montgomery Asberg Depression Rating Scale (MADRS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- CP-601,927
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 297 participants
- Where
- 58 sitesUnited States
- Study dates
- 14 Jun 2010to 12 Sep 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Medically healthy males or females aged 18-65 (inclusive).
- Patients must have a primary current diagnosis of MDD without psychotic features.
- Patients must be receiving ongoing antidepressant therapy at the time of screening. Duration of the current episode of MDD must be at least 8 weeks prior to enrollment without adequate response to treatment.
Who cannot join
- Patients with other psychiatric disorders.
- Patients who use tobacco products.
- Alcohol or substance abuse or dependence.
- Treatment with a monoamine oxidase inhibitor within 10 weeks of enrollment.
- Pregnancy or breastfeeding.
- Clinically significant abnormalities on laboratory tests, electrocardiogram, or physical or neurologic examination.
Trial locations and contacts
58 sites in 1 country.
58 sites in 1 country
United States58 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Atlanta Institute of Medicine and Research
Atlanta, Georgia, 30328
FutureSearch Trials
Austin, Texas, 78731
City Line Family Medicine
Bala-Cynwyd, Pennsylvania, 19004
Southwestern Research Incorporated
Beverly Hills, California, 90210
Massachusetts General Hospital
Boston, Massachusetts, 02171
Social Psychiatry Research Institute
Brooklyn, New York, 11235
Northbrooke Research Center
Brown Deer, Wisconsin, 53223
Erie County Medical Center / State University of New York at Buffalo affiliate
Buffalo, New York, 14215
University of Virginia Health System / Department of Psychiatry and Neurobehavioral Sciences
Charlottesville, Virginia, 22903
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
Carolina Clinical Research Service LLC
Columbia, South Carolina, 29201
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, 75231
University of Texas (UT) Southwestern Medical Center at Dallas
Dallas, Texas, 75235
University of Texas (UT) Southwestern Medical Center at Dallas
Dallas, Texas, 75390-9119
Midwest Clinical Research Center
Dayton, Ohio, 45417
Radiant Research, Inc.
Denver, Colorado, 80239
InSite Clinical Research
DeSoto, Texas, 75115
AccelRx Research
Fall River, Massachusetts, 02721
Comprehensive NeuroScience, Inc.
Fresh Meadows, New York, 11366
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, 46260
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70629
Lincoln Research
Lincoln, Rhode Island, 02865
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, 72223
Florida Clinical Research Center, LLC
Maitland, Florida, 32751
Suburban Research Associates
Media, Pennsylvania, 19063
Dean Foundation for Health, Research and Education
Middleton, Wisconsin, 53562
AMR-Baber Research Inc.
Naperville, Illinois, 60563
Synergy Clinical Research Center
National City, California, 91950
Louisiana Research Associates, Inc.
New Orleans, Louisiana, 70114
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360
William B. Backus Hospital Satellite Blood Draw
Norwich, Connecticut, 06360
IPS Research
Oklahoma City, Oklahoma, 73103
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806
University of Pennsylvania / Department of Psychiatry
Philadelphia, Pennsylvania, 19104
Frankford Avenue Family Practice, PC
Philadelphia, Pennsylvania, 19136
Summit Research Network (Oregon), Inc.
Portland, Oregon, 97210
Mcguire Hall Annex
Richmond, Virginia, 23219
Nelson Clinic
Richmond, Virginia, 23219
Virginia Commonwealth University (VCU) Medical Center
Richmond, Virginia, 23298-0155
Detroit Bio-Medical Laboratories, Inc.
Rochester Hills, Michigan, 48307
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63301
Radiant Research, Inc
Salt Lake City, Utah, 84107
University of Utah School of Medicine Department of Psychiatry Mood Disorders Clinic
Salt Lake City, Utah, 84132
Artemis Institute for Clinical Research
San Diego, California, 92123
Louisiana Clinical Research, LLC
Shreveport, Louisiana, 71115
Psychiatric Medicine Associates, LLC.
Skokie, Illinois, 60076
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, 33716
Clinco
Terre Haute, Indiana, 47802
Montefiore Medical Center
The Bronx, New York, 10467
Kettlie Joseph Daniels, MD, Inc.
Toledo, Ohio, 43609
Neurology and Neuroscience Center of Ohio
Toledo, Ohio, 43623
Heartland Research Associates, LLC
Wichita, Kansas, 67207
About this study
Official title: A RANDOMIZED PHASE 2A, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF CP-601,927 AUGMENTATION OF ANTIDEPRESSANT THERAPY IN MAJOR DEPRESSION
The primary objectives of this study are to: 1) Evaluate the efficacy of CP 601,927 compared to placebo in the augmentation of antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD) using the Montgomery Asberg Depression Rating Scale (MADRS). 2) Evaluate the safety and tolerability of CP 601,927 in patients with MDD on ADT.
Read the detailed description
The study was stopped at interim analysis in August 2011, as stopping criteria for futility were met. There was no statistically significant change on the primary efficacy scale in favor of the drug. There was a very small chance that any additional data could change the study overall outcome. There were no concerns regarding subject safety.
- Conditions
- Major Depressive Disorder
- Being tested
- CP-601,927, Placebo
- Keywords
- Antidepressant Augmentation
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-601,927Drug
CP-601,927 1-2 mg twice per day, oral 1 mg tablets, for 6 weeks.
PlaceboOther
Matching placebo tablets, taken orally, twice per day, for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | CP-601,927 Receives: Drug: CP-601,927 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 14
MADRS measures the overall severity of depressive symptoms. The MADRS had a 10-item checklist. Items are rated on a scale of 0-6, for a total numeric range of scores from 0 (depressive symptoms absent) to 60 (numerically highest level of depressive symptoms).
Measured: Week 8 (double-blind baseline ) and week 14 (week 6 of double-blind phase)
Secondary outcomes (12)
Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Weeks 9 Through 13
MADRS measures the overall severity of depressive symptoms. The MADRS had a 10-item checklist. Items are rated on a scale of 0-6, for a total numeric range of scores from 0 (depressive symptoms absent) to 60 (numerically highest level of depressive symptoms).
Measured: Week 8 (double-blind baseline) and weeks 9 through 13
Change From Double-blind Baseline in Hamilton Depression Scale 25-item (HAM-D25) - Total Score at Weeks 9 Through 14
The HAM-D25 is the 25-item version of a scale used to assess the range of depressive symptoms including depressed mood, work and activities, sleep, suicidal thinking, psychomotor agitation/retardation, appetite, sexual interest, anxiety, somatic symptoms, and cognitive symptoms. The items on the HAM-D were rated on a scale of 0-2 or 0-4, for a total numeric range of scores from 0 (depressive symptoms absent) to 72 (numerically highest level of depressive symptoms).
Measured: Weeks 8 (double-blind baseline) through 14
Change From Double-blind Baseline in Bech Melancholia Subscale Score at Weeks 9 Through 14
The Bech Melancholia is sum of scores on 6 items (items 1, 2, 7, 8, 10 and 13) pertaining to melancholia within HAM-D. The items are rated on a scale of 0-4, higher scores reflecting greater severity. Total possible score is 0-24.
Measured: Weeks 8 (double-blind baseline) through 14
Change From Double-blind Baseline in Clinical Global Impression - Severity (CGI-S) at Weeks 9, 10, 12, and 14
CGI-S was defined as 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected.
Measured: Week 8 (double-blind baseline) and weeks 9, 10, 12, 14
Change From Double-blind Baseline in Sheehan Irritability Scale (SIS) Total Score at Weeks 11 and 14
The SIS is to rate suffering with regard to irritability symptoms. The degree to which irritability interferes with work, social and family function is also queried. The total SIS score is the sum of 7 items. Each item is rated on a scale of 0-10, for a total numeric range of scores from 0 (not at all) to 70 (extremely). The SIS also records the number of days impaired by irritability.
Measured: Weeks 8 (double-blind baseline), 11 and 14
Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Total Score at Weeks 11 and 14
SDS is defined as a self-administered tool that measures functional impairment including work/school, social life, and family life/home responsibilities. Items are rated on a scale of 0-10 visual analog scale (0=not at all impaired, 10=extremely impaired), for a total numeric range of scores from 0 (not at all impaired) to 30 (extremely impaired).
Measured: Weeks 8 (double-blind baseline), 11 and 14
Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Subscale Score at Weeks 11 and 14
SDS subscale is defined as a self-administered tool that measures functional impairment in 3-item including work/school, social life, and family life/home responsibilities. Items are rated on a scale of 0-10 visual analog scale, for a total numeric range of scores from 0 (not at all impaired) to 30 (extremely impaired).
Measured: Weeks 8 (double-blind baseline), 11 and 14
Clinical Global Impression - Improvement (CGI-I) Total Score at Weeks 9, 10, 12 and 14
CGI-I was defined as a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Measured: Weeks 8 (double-blind baseline) 9, 10, 12 and 14
Number of Participants With Remission at Weeks 9, 10, 12 and 14
Remission was defined as response plus an absolute MADRS total score of less than or equal to 10 plus a CGI-I score less than 2 ('much' or 'very much' improved).
Measured: Weeks 9, 10, 12 and 14
Number of Participants With Response at Weeks 9 Through 14
Response was defined as greater than 50 percent reduction from double-blind baseline in MADRS total score.
Measured: Weeks 9 through 14
Population Pharmacokinetics
Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for CP-601,927 and to determine inter-individual and residual variability in population clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured CP-601,927 concentrations
Measured: Weeks 11,12 and 14
Plasma CP-601,927 Concentration
Blood samples were collected for plasma CP-601,927 concentration analysis which was summarized by mean and standard deviation.
Measured: Week 11, 12 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study start14 Jun 2010
- Primary completion12 Sep 2011
- Study completion12 Sep 2011
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098240
- Sponsor's protocol ID
- A3331017
- Status last verified
- Apr 2021
- First submitted
- 1 Apr 2010
- Last updated
- 3 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Publications
Fava M, Ramey T, Pickering E, Kinrys G, Boyer S, Altstiel L. A randomized, double-blind, placebo-controlled phase 2 study of the augmentation of a nicotinic acetylcholine receptor partial agonist in depression: is there a relationship to leptin levels? J Clin Psychopharmacol. 2015 Feb;35(1):51-6. doi: 10.1097/JCP.0000000000000245.
PubMed 25422883
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZED PHASE 2A, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF CP-601,927 AUGMENTATION OF ANTIDEPRESSANT THERAPY IN MAJOR DEPRESSION
- ClinicalTrials.gov ID
- NCT01098240
- Acronym / sponsor ID
- A3331017
- Conditions
- Major Depressive Disorder
- Keywords
- Antidepressant Augmentation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 297 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2010 (actual)
- Primary completion
- 12 Sep 2011 (actual)
- Study completion
- 12 Sep 2011 (actual)
- First posted
- 2 Apr 2010 (estimated)
- Results
- Posted 26 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to: 1) Evaluate the efficacy of CP 601,927 compared to placebo in the augmentation of antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD) using the Montgomery Asberg Depression Rating Scale (MADRS). 2) Evaluate the safety and tolerability of CP 601,927 in patients with MDD on ADT.
Detailed description
The study was stopped at interim analysis in August 2011, as stopping criteria for futility were met. There was no statistically significant change on the primary efficacy scale in favor of the drug. There was a very small chance that any additional data could change the study overall outcome. There were no concerns regarding subject safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Drug: CP-601,927CP-601,927 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medically healthy males or females aged 18-65 (inclusive).
- Patients must have a primary current diagnosis of MDD without psychotic features.
- Patients must be receiving ongoing antidepressant therapy at the time of screening. Duration of the current episode of MDD must be at least 8 weeks prior to enrollment without adequate response to treatment.
Key exclusion criteria (6 listed)
- Patients with other psychiatric disorders.
- Patients who use tobacco products.
- Alcohol or substance abuse or dependence.
- Treatment with a monoamine oxidase inhibitor within 10 weeks of enrollment.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| CP-601,927CP-601,927 1-2 mg twice per day, oral 1 mg tablets, for 6 weeks. | Drug | Active Treatment |
| PlaceboMatching placebo tablets, taken orally, twice per day, for 6 weeks. | Other | Placebo |
Primary outcome
Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 14
Time frame: Week 8 (double-blind baseline ) and week 14 (week 6 of double-blind phase)
MADRS measures the overall severity of depressive symptoms. The MADRS had a 10-item checklist. Items are rated on a scale of 0-6, for a total numeric range of scores from 0 (depressive symptoms absent) to 60 (numerically highest level of depressive symptoms).
12 secondary outcomes
Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Weeks 9 Through 13
Time frame: Week 8 (double-blind baseline) and weeks 9 through 13
Change From Double-blind Baseline in Hamilton Depression Scale 25-item (HAM-D25) - Total Score at Weeks 9 Through 14
Time frame: Weeks 8 (double-blind baseline) through 14
Change From Double-blind Baseline in Bech Melancholia Subscale Score at Weeks 9 Through 14
Time frame: Weeks 8 (double-blind baseline) through 14
Change From Double-blind Baseline in Clinical Global Impression - Severity (CGI-S) at Weeks 9, 10, 12, and 14
Time frame: Week 8 (double-blind baseline) and weeks 9, 10, 12, 14
Change From Double-blind Baseline in Sheehan Irritability Scale (SIS) Total Score at Weeks 11 and 14
Time frame: Weeks 8 (double-blind baseline), 11 and 14
Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Total Score at Weeks 11 and 14
Time frame: Weeks 8 (double-blind baseline), 11 and 14
Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Subscale Score at Weeks 11 and 14
Time frame: Weeks 8 (double-blind baseline), 11 and 14
Clinical Global Impression - Improvement (CGI-I) Total Score at Weeks 9, 10, 12 and 14
Time frame: Weeks 8 (double-blind baseline) 9, 10, 12 and 14
Number of Participants With Remission at Weeks 9, 10, 12 and 14
Time frame: Weeks 9, 10, 12 and 14
Number of Participants With Response at Weeks 9 Through 14
Time frame: Weeks 9 through 14
Population Pharmacokinetics
Time frame: Weeks 11,12 and 14
Plasma CP-601,927 Concentration
Time frame: Week 11, 12 and 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25422883Fava M, Ramey T, Pickering E, Kinrys G, Boyer S, Altstiel L. A randomized, double-blind, placebo-controlled phase 2 study of the augmentation of a nicotinic acetylcholine receptor partial agonist in depression: is there a relationship to leptin levels? J Clin Psychopharmacol. 2015 Feb;35(1):51-6. doi: 10.1097/JCP.0000000000000245.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
58 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP-601,927 in people with Major Depressive Disorder, run by Pfizer at 58 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 3 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: stopped early, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 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. 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?
Yes. Results are posted in the registry (first posted 26 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 14 (time frame: Week 8 (double-blind baseline ) and week 14 (week 6 of double-blind phase)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01098240, which also lists 1 linked publication.
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 May 2021.