SchizophreniaPhase 3PEARL 3NCT00790192

Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.

A Phase 3 study testing Lurasidone and Quetiapine XR in people with Schizophrenia, run by Sumitomo Pharma America, Inc. at 65 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR short term among acutely psychotic patients with chronic schizophrenia. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Schizophrenia
What is being tested?: Lurasidone and Quetiapine XR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 488 participants
Where: 65 sitesin 5 countries
Study dates: Oct 2008to Jul 2010
Phase: Phase 3
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provide written informed consent and aged between 18 and 75 years of age.
Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia.
Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
Able and agrees to remain off prior antipsychotic medication for the duration of study.
Good physical health on the basis of medical history, physical examination, and laboratory screening.
Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Who cannot join

Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
Any chronic organic disease of the CNS (other than schizophrenia).
Used investigational compound within 30 days.
Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.

Trial locations and contacts

65 sites in 5 countries.

Country

City, postcode or hospital

65 sites in 5 countries

United States29 sites

Community Clinical Research
Austin, Texas, 78729
Future Search Trials of Neurology
Austin, Texas, 78756
Florida Clinical Research Center
Bradenton, Florida, 34208
Clinical Pharmacological Studies, Inc.
Cerritos, California, 90703
Comprehensive Neuroscience, Inc
Cerritos, California, 90703
Clinical Innovations, Inc.
Costa Mesa, California, 92647
Pillar Clinical Research
Dallas, Texas, 75243
Synergy Escondido
Escondido, California, 92025
Precise Clinical Research
Flowood, Mississippi, 39232
Florida Clinical Research Center, LLC
Fruitland Park, Florida, 34731
Collaborative Neuroscience Network
Garden Grove, California, 92645
Segal Institute for Clinical Research
Highlands Ranch, Colorado, 80103
Comprehensive Neuroscience, Inc
Holliswood, New York, 11423
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70601
K&S Professional Research Services, LLC
Little Rock, Arkansas, 72201
Woodland International Research Group
Little Rock, Arkansas, 72211
Apostle Clinical Trials, Inc.
Long Beach, California, 90813
California Clinical Trials
Paramount, California, 90723
Pasadena Research Institute
Pasadena, California, 91107
CNRI-Los Angeles. LLC
Pico Rivera, California, 90660
Clinical Innovations, Inc.
Riverside, California, 92647
St. Charles Psychiatric Associates
Saint Charles, Missouri, 63301
CNRI-San Diego
San Diego, California, 92126
UCSD Medical Center
Sandeigo, California, 92103
Booker, J. Gary, MD. APMC
Shreveport, Louisiana, 71104
St. Louis Research, Inc.
St Louis, Missouri, 63118
Comprehensive Neuroscience, Inc.
Washington D.C., District of Columbia, 20016
CRI Worldwide
Willingboro, New Jersey, 08046
Segal Institute for Clinical Research
Winston-Salem, North Carolina, 27104

Other trials in United States

Russia11 sites

SEI of H.P. Educat. Northern SMU
Arkhangelsk, 163060
St. Petersburg SHI Psychiatrical Hosptial #1 n.a. Kaschenko
Gatchina, 188357
Moscow Scientific Research Institute of Psychiatry
Moscow, 107076
Institution of RAMS Mental Health Research Center of RAMS
Moscow, 115522
City Clinical Psichiatric Hospital #1
Nizhny Novgorod, 603 155
City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
Saint Petersburg
City Psychiatric Hospital #3 of Skvortsov-Stepanov
Saint Petersburg
City Psychiatric Hospital #4
Saint Petersburg
SHI City Psychoneurological Dispensary #7
Saint Petersburg
St. Petersburg GUZ City Psychiatric Hospital #6
Saint Petersburg
SHI Samara Psychiatric Hospital
Samara, 443016

Other trials in Russia

India10 sites

Seth K M School of P G Medicine & Research
Ahmedabad, Gujarat, 380006
Madras Medical College & Government General Hospital
Chennai, Tamil Nadu, 600003
Shanti Nursing Home
Chhatrapati Sambhajinagar, Maharashtra, 431005
Justice K.S. Hegde Charitable Hospital
Mangalore, Karnataka, 574160
JSS Medical College and Hospital
Mysore, Karnataka, 570004
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, 411004
Mahatma Gandhi Institute of Medical Sciences
Sewāgrām, Maharashtra, 442102
S.V. Medical College
Tirupati, Andhra Pradesh, 517507
SBKS Medical Institute and Research Centre
Vadodara, Gujarat, 391760
Vijayawada Institute of Mental Health and Neurosciences
Vijayawada, Andhra Pradesh, 520002

Other trials in India

Ukraine9 sites

RCH n.a.I.I.Mechnikov, Reg.Cent. of Psychosom. Pathology
Dnipropetrovsk, 49005
Chair of Psychiatry and Medical Psychology
Donetsk, 83008
Kherson Regional Psychiatric Hospital
Kherson,vil., Stepanovka, 73488
Centre of Novel Treatment and Rehabilitation of Psychotic disorders
Kyiv
Kyiv City Psychoneurological Hospital
Kyviv
Lviv Reg.St.Cl.Psych.Hosp
Lviv
Reg. Psychiatric Hospital
Odesa
Poltava Regional Clinical Psychiatric Hospital,
Poltava
Crimean republican Clinical Psychiatric Hospital
Simferopol

Other trials in Ukraine

Romania6 sites

Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos"
Bdul Nicolae Grigorescu Nr. 41, Bucharest, 030440
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
Bucharest
Spitalul Clinic de Neurologie si Psihiatrie Oradea
Oradea
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia
Sos. Berceni Nr. 10-12, Bucharest, 041914
Spitalul Judetean Arges
Str. Negru Voda Nr. 53, Pitesti, 110069
Spitalul Clinic Judetean de Urgenta Arad
Str. Octavian Goga Nr. 17, Arad, 310022

Other trials in Romania

About this study

Official title: A Phase 3 Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Two Doses of Lurasidone in Acutely Psychotic Subjects With Schizophrenia (PEARL 3)

Conditions: Schizophrenia
Being tested: Lurasidone, Quetiapine XR, Placebo
Keywords: Schizophrenia, SM-13496, Latuda, Lurasidone
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LurasidoneDrug
Lurasidone 80 mg tablets
LurasidoneDrug
Lurasidone 4 40 mg tablets
Quetiapine XRDrug
Quetiapine XR 600mg
PlaceboDrug
Matching Placebo to Lurasidone or Quetiapine

Study groups in NCT00790192
Study group	Role	What they receive
Lurasidone 80mg	Experimental	Not described Receives: Drug: Lurasidone
Lurasidone 160mg	Experimental	Not described Receives: Drug: Lurasidone
Quetiapine XR	Active comparator	Not described Receives: Drug: Quetiapine XR
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.

Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Measured: Week 6

Secondary outcomes (1)

Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment
Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).
Measured: 6-Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Jul 2010

First posted13 Nov 2008 (estimated)
Study startOct 2008
Primary completionJul 2010
Study completionJul 2010

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 (7)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 488 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00790192
Sponsor's protocol ID: D1050233
Acronym: PEARL 3
Status last verified: Mar 2016
First submitted: 10 Nov 2008
Last updated: 17 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Loebel A, Cucchiaro J, Sarma K, Xu L, Hsu C, Kalali AH, Pikalov A, Potkin SG. Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial. Schizophr Res. 2013 Apr;145(1-3):101-9. doi: 10.1016/j.schres.2013.01.009. Epub 2013 Feb 13.
PubMed 23415311
Harvey PD, Siu CO, Hsu J, Cucchiaro J, Maruff P, Loebel A. Effect of lurasidone on neurocognitive performance in patients with schizophrenia: a short-term placebo- and active-controlled study followed by a 6-month double-blind extension. Eur Neuropsychopharmacol. 2013 Nov;23(11):1373-82. doi: 10.1016/j.euroneuro.2013.08.003. Epub 2013 Aug 27.
PubMed 24035633
Loebel AD, Siu CO, Cucchiaro JB, Pikalov AA, Harvey PD. Daytime sleepiness associated with lurasidone and quetiapine XR: results from a randomized double-blind, placebo-controlled trial in patients with schizophrenia. CNS Spectr. 2014 Apr;19(2):197-205. doi: 10.1017/S1092852913000904. Epub 2013 Dec 13.
PubMed 24330860
Hopkins SC, Tomioka S, Ogirala A, Loebel A, Koblan KS, Marder SR. Assessment of Negative Symptoms in Clinical Trials of Acute Schizophrenia: Test of a Novel Enrichment Strategy. Schizophr Bull Open. 2022 Apr 7;3(1):sgac027. doi: 10.1093/schizbullopen/sgac027. eCollection 2022 Jan.
PubMed 39144777
Hopkins SC, Ogirala A, Worden M, Koblan KS. Depicting Safety Profile of TAAR1 Agonist Ulotaront Relative to Reactions Anticipated for a Dopamine D2-Based Pharmacological Class in FAERS. Clin Drug Investig. 2021 Dec;41(12):1067-1073. doi: 10.1007/s40261-021-01094-7. Epub 2021 Nov 9.
PubMed 34751928
Harvey PD, Siu CO, Ogasa M, Loebel A. Effect of lurasidone dose on cognition in patients with schizophrenia: post-hoc analysis of a long-term, double-blind continuation study. Schizophr Res. 2015 Aug;166(1-3):334-8. doi: 10.1016/j.schres.2015.06.008. Epub 2015 Jun 24.
PubMed 26117157
Nasrallah HA, Cucchiaro JB, Mao Y, Pikalov AA, Loebel AD. Lurasidone for the treatment of depressive symptoms in schizophrenia: analysis of 4 pooled, 6-week, placebo-controlled studies. CNS Spectr. 2015 Apr;20(2):140-7. doi: 10.1017/S1092852914000285. Epub 2014 Jun 23.
PubMed 24955752

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Two Doses of Lurasidone in Acutely Psychotic Subjects With Schizophrenia (PEARL 3)
ClinicalTrials.gov ID: NCT00790192
Acronym / sponsor ID: PEARL 3 / D1050233
Conditions: Schizophrenia
Keywords: Schizophrenia, SM-13496, Latuda, Lurasidone
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 488 participants (actual)
Lead sponsor: Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 13 Nov 2008 (estimated)
Results: Posted 6 Oct 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Lurasidone 80mg	Experimental	Drug: Lurasidone
Lurasidone 160mg	Experimental	Drug: Lurasidone
Quetiapine XR	Active comparator	Drug: Quetiapine XR
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Provide written informed consent and aged between 18 and 75 years of age.
Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia.
Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
Able and agrees to remain off prior antipsychotic medication for the duration of study.
Good physical health on the basis of medical history, physical examination, and laboratory screening.

Key exclusion criteria (4 listed)

Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
Any chronic organic disease of the CNS (other than schizophrenia).
Used investigational compound within 30 days.
Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.

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
LurasidoneLurasidone 80 mg tablets	Drug	Lurasidone 80mg
LurasidoneLurasidone 4 40 mg tablets	Drug	Lurasidone 160mg
Quetiapine XRQuetiapine XR 600mg	Drug	Quetiapine XR
PlaceboMatching Placebo to Lurasidone or Quetiapine	Drug	Placebo

Primary outcome

Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
Time frame: Week 6
The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.

1 secondary outcome

Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment
Time frame: 6-Weeks

Results and safety

Results posted to the registry on 6 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lurasidone 80 mg	125	89
Lurasidone 160 mg	121	93
Quetiapine XR 600mg	120	97
Placebo	122	74

Primary outcome: Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase

Time frame: Week 6. Least squares mean (95% Confidence Interval). Unit: scores on a scale

Measure	Lurasidone 80 mg n = 125	Lurasidone 160 mg n = 121	Quetiapine XR 600mg n = 116	Placebo n = 120
Value	-22.2 (-25.7 to -18.7)	-26.5 (-30.0 to -23.0)	-27.8 (-31.3 to -24.2)	-10.3 (-13.9 to -6.7)

Lurasidone 80 mg vs Lurasidone 160 mg vs Quetiapine XR 600mg vs Placebo: p <0.05, Mixed Models Analysis

Population analysed: The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 14 days post study therapy. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lurasidone 80 mg	1 of 125 (0.8%)	71 of 125 (56.8%)	Not reported
Lurasidone 160 mg	4 of 121 (3.3%)	76 of 121 (62.8%)	Not reported
Quetiapine XR 600mg	1 of 119 (0.8%)	70 of 119 (58.8%)	Not reported
Placebo	4 of 121 (3.3%)	69 of 121 (57%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23415311Loebel A, Cucchiaro J, Sarma K, Xu L, Hsu C, Kalali AH, Pikalov A, Potkin SG. Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial. Schizophr Res. 2013 Apr;145(1-3):101-9. doi: 10.1016/j.schres.2013.01.009. Epub 2013 Feb 13.
Results publication: PubMed 24035633Harvey PD, Siu CO, Hsu J, Cucchiaro J, Maruff P, Loebel A. Effect of lurasidone on neurocognitive performance in patients with schizophrenia: a short-term placebo- and active-controlled study followed by a 6-month double-blind extension. Eur Neuropsychopharmacol. 2013 Nov;23(11):1373-82. doi: 10.1016/j.euroneuro.2013.08.003. Epub 2013 Aug 27.
Results publication: PubMed 24330860Loebel AD, Siu CO, Cucchiaro JB, Pikalov AA, Harvey PD. Daytime sleepiness associated with lurasidone and quetiapine XR: results from a randomized double-blind, placebo-controlled trial in patients with schizophrenia. CNS Spectr. 2014 Apr;19(2):197-205. doi: 10.1017/S1092852913000904. Epub 2013 Dec 13.
Derived from this study: PubMed 39144777Hopkins SC, Tomioka S, Ogirala A, Loebel A, Koblan KS, Marder SR. Assessment of Negative Symptoms in Clinical Trials of Acute Schizophrenia: Test of a Novel Enrichment Strategy. Schizophr Bull Open. 2022 Apr 7;3(1):sgac027. doi: 10.1093/schizbullopen/sgac027. eCollection 2022 Jan.
Derived from this study: PubMed 34751928Hopkins SC, Ogirala A, Worden M, Koblan KS. Depicting Safety Profile of TAAR1 Agonist Ulotaront Relative to Reactions Anticipated for a Dopamine D2-Based Pharmacological Class in FAERS. Clin Drug Investig. 2021 Dec;41(12):1067-1073. doi: 10.1007/s40261-021-01094-7. Epub 2021 Nov 9.
Derived from this study: PubMed 26117157Harvey PD, Siu CO, Ogasa M, Loebel A. Effect of lurasidone dose on cognition in patients with schizophrenia: post-hoc analysis of a long-term, double-blind continuation study. Schizophr Res. 2015 Aug;166(1-3):334-8. doi: 10.1016/j.schres.2015.06.008. Epub 2015 Jun 24.
Derived from this study: PubMed 24955752Nasrallah HA, Cucchiaro JB, Mao Y, Pikalov AA, Loebel AD. Lurasidone for the treatment of depressive symptoms in schizophrenia: analysis of 4 pooled, 6-week, placebo-controlled studies. CNS Spectr. 2015 Apr;20(2):140-7. doi: 10.1017/S1092852914000285. Epub 2014 Jun 23.

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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.

Medical Director, MD study director

Sumitomo Pharma America, Inc.

65 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lurasidone and Quetiapine XR in people with Schizophrenia, run by Sumitomo Pharma America, Inc. at 65 sites in 5 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Russia, India, Ukraine, Romania. 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 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?

Yes. Results are posted in the registry (first posted 6 Oct 2011). 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?

Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase (time frame: Week 6). 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 NCT00790192, which also lists 7 linked publications.

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 17 Mar 2016.