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SchizophreniaPhase 3NCT01515423

Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia

A Phase 3 study testing PP3M 175 mg eq., PP3M 263 mg eq. and PP3M 350 mg eq. in people with Schizophrenia, run by Janssen Research & Development, LLC at 174 sites in 26 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

The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Schizophrenia
What is being tested?
PP3M 175 mg eq., PP3M 263 mg eq. and PP3M 350 mg eq.
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,429 participants
Where
174 sitesin 26 countries
Study dates
May 2012to Mar 2015
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with schizophrenia for more than 1 year and whose symptoms are worsening in the opinion of the investigator
  • A total score in the Positive and Negative Syndrome Scale (PANSS) between 70 and 120
  • Signed informed consent
  • Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control
  • Men must agree to use a double-barrier method of birth control
  • Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG)

Who cannot join

  • A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis
  • Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc)
  • A diagnosis of substance dependence within 6 months before screening
  • History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia
  • Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness
  • Clinically significant findings in biochemistry, hematology, ECG or urinalysis results
  • Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments

Trial locations and contacts

174 sites in 26 countries.

174 sites in 26 countries

Japan39 sites

  • Study site

    Aizu-Wakamatsu

  • Study site

    Fujioka

  • Study site

    Fujisawa

  • Study site

    Hadano

  • Study site

    Himeji

  • Study site

    Hitachi

  • Study site

    Ichikawa

  • Study site

    Kanuma

  • Study site

    Kanzaki

  • Study site

    Kashihara

  • Study site

    Kashiwara

  • Study site

    Kasuya

  • Study site

    Kawasaki

  • Study site

    Kitagunma

  • Study site

    Kochi

  • Study site

    Kodaira

  • Study site

    Kumagaya

  • Study site

    Kumamoto

  • Study site

    Kure

  • Study site

    Matsusaka

  • Study site

    Mitaka

  • Study site

    Moriguchi

  • Study site

    Nagasaki

  • Study site

    Naha

  • Study site

    Nirasaki

  • Study site

    Ohta

  • Study site

    Okayama

  • Study site

    Okinawa

  • Study site

    Sakai

  • Study site

    Shibukawa

  • Study site

    Takatsuki

  • Study site

    Toki

  • Study site

    Tokushima

  • Study site

    Tokyo

  • Study site

    Toyoake

  • Study site

    Ueda

  • Study site

    Yatsushiro

  • Study site

    Yokkaichi

  • Study site

    Yokohama

Other trials in Japan

United States24 sites

  • Study site

    Austin, Texas

  • Study site

    Bothell, Washington

  • Study site

    Bradenton, Florida

  • Study site

    Canton, Ohio

  • Study site

    Charleston, South Carolina

  • Study site

    Durham, North Carolina

  • Study site

    East Lansing, Michigan

  • Study site

    Glendale, California

  • Study site

    Jamaica, New York

  • Study site

    Kissimmee, Florida

  • Study site

    Las Vegas, Nevada

  • Study site

    Little Rock, Arkansas

  • Study site

    Long Beach, California

  • Study site

    Memphis, Tennessee

  • Study site

    New Britain, Connecticut

  • Study site

    Oakland, California

  • Study site

    Oceanside, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orange, California

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    San Diego, California

  • Study site

    St Louis, Missouri

  • Study site

    Tampa, Florida

  • Study site

    Wichita, Kansas

Other trials in United States

Russia13 sites

  • Study site

    Arkhangelsk

  • Study site

    Gatchina

  • Study site

    Krasnodar

  • Study site

    Moscow

  • Study site

    Nizhny Novgorod

  • Study site

    Saint Petersburg

  • Study site

    Saratov

  • Study site

    Smolensk

  • Study site

    Smolensk Region N/A

  • Study site

    St-Peterburg

  • Study site

    Tomsk Na

  • Study site

    Yaroslavl

  • Study site

    Yekaterinburg

Other trials in Russia

China11 sites

  • Study site

    Baoding

  • Study site

    Beijing

  • Study site

    Changsha

  • Study site

    Guangdong

  • Study site

    Guangzhou

  • Study site

    Hangzhou

  • Study site

    Kunming

  • Study site

    Shanghai

  • Study site

    Tianjin

  • Study site

    Wuhan

  • Study site

    Xi'an

Other trials in China

Poland9 sites

  • Study site

    Bełchatów

  • Study site

    Bydgoszcz

  • Study site

    Chełmno

  • Study site

    Gdynia Na

  • Study site

    Lubin

  • Study site

    Lubliniec

  • Study site

    Piekary Śląskie

  • Study site

    Torun

  • Study site

    Ząbki

Other trials in Poland

Belgium7 sites

  • Study site

    Assebroek

  • Study site

    Bertrix

  • Study site

    Dave

  • Study site

    Heusden

  • Study site

    Jette

  • Study site

    Marchienne-au-Pont

  • Study site

    Sint-Denijs-Westrem

Other trials in Belgium

Spain7 sites

  • Study site

    Alicante

  • Study site

    Barakaldo

  • Study site

    Barcelona

  • Study site

    Coslada

  • Study site

    Elche

  • Study site

    Madrid

  • Study site

    Zamora

Other trials in Spain

Czechia5 sites

  • Study site

    Brno

  • Study site

    Hořovice

  • Study site

    Liberec

  • Study site

    Prague

  • Study site

    Přerov

Other trials in Czechia

Germany5 sites

  • Study site

    Bochum

  • Study site

    Gelsenkirchen

  • Study site

    Hamburg

  • Study site

    Heidelberg

  • Study site

    München

Other trials in Germany

Hungary5 sites

  • Study site

    Balassagyarmat

  • Study site

    Budapest

  • Study site

    Gyõr

  • Study site

    Kalocsa

  • Study site

    Sopron

Other trials in Hungary

Portugal5 sites

  • Study site

    Almada

  • Study site

    Angra do Heroísmo

  • Study site

    Coimbra

  • Study site

    Lisbon

  • Study site

    Porto

Other trials in Portugal

Ukraine5 sites

  • Study site

    Hlevakha

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Odesa

  • Study site

    Poltava

Other trials in Ukraine

Bulgaria4 sites

  • Study site

    Burgas

  • Study site

    Kazanlak

  • Study site

    Radnevo

  • Study site

    Sofia

Other trials in Bulgaria

Canada4 sites

  • Study site

    Burlington

  • Study site

    Calgary, Alberta

  • Study site

    Halifax, Ontario

  • Study site

    Montreal, Quebec

Other trials in Canada

France4 sites

  • Study site

    Clermont-Ferrand

  • Study site

    Dole

  • Study site

    Montpellier

  • Study site

    Toulon

Other trials in France

Slovakia4 sites

  • Study site

    Bratislava

  • Study site

    Michalovce

  • Study site

    Rimavská Sobota

  • Study site

    Trenčín

Other trials in Slovakia

South Korea4 sites

  • Study site

    Busan

  • Study site

    Gwangju

  • Study site

    Gyeonggi-do

  • Study site

    Seoul

Other trials in South Korea

Argentina3 sites

  • Study site

    Buenos Aires

  • Study site

    Córdoba

  • Study site

    Rosario

Other trials in Argentina

Greece3 sites

  • Study site

    Arta

  • Study site

    Athens

  • Study site

    Katerini

Other trials in Greece

Mexico3 sites

  • Study site

    Guadalajara

  • Study site

    Monterrey

  • Study site

    Tlalnepantla

Other trials in Mexico

Taiwan3 sites

  • Study site

    Bali Township, Taipei County

  • Study site

    Kaohsiung City

  • Study site

    Taoyuan

Other trials in Taiwan

Australia2 sites

  • Study site

    Elizabeth Vale

  • Study site

    Frankston

Other trials in Australia

Romania2 sites

  • Study site

    Brasov

  • Study site

    Cluj-Napoca

Other trials in Romania

Austria1 site

  • Study site

    Innsbruck

Other trials in Austria

Brazil1 site

  • Study site

    Rio de Janeiro

Other trials in Brazil

Sweden1 site

  • Study site

    Uppsala

Other trials in Sweden

About this study

Official title: A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia

The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.

Read the detailed description

This is a randomized (the study drug is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel group (each group of patients will be treated at the same time), multicenter non-inferiority (the effect of the new treatment is not worse than that of the comparison treatment) study. A new formulation of paliperidone palmitate with a 3-month injection interval (PP3M) is being tested for use as maintenance treatment for subjects with schizophrenia who have been first stabilized on paliperidone palmitate with a 1-month injection interval (PP1M). The study consists of 3 phases: a screening/washout/tolerability phase (up to 21 days); a 17-week open-label (all people know the identity of the intervention) stabilization phase (referred to as the Open-label Phase) and a 48-week fixed dose, randomized, double-blind controlled phase (referred to as the Double-blind Phase). After completion of the Screening Phase, all patients will receive PP1M in the Open-label Phase. During this time, flexible dosing will occur at Weeks 5 and 9. At Week 13 patients are to receive the dose of PP1M that was administered at Week 9. Patients who are clinically stable at the end of the Open-label Phase will enter the Double-blind Phase and will be randomly assigned in a 1:1 ratio to receive fixed doses of PP3M or PP1M.

Conditions
Schizophrenia
Being tested
PP3M 175 mg eq., PP3M 263 mg eq., PP3M 350 mg eq., PP3M 525 mg eq., Placebo (20% Intralipid)
Keywords
Schizophrenia, R092670, Paliperidone Palmitate, Paliperidone palmitate 1 month formulation (PP1M), Paliperidone palmitate 3 month formulation (PP3M)
Medical subject headings
Schizophrenia

What participants receive

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

  • PP3M 175 mg eq.Drug

    Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every third month for 48 weeks.

  • PP3M 263 mg eq.Drug

    Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every third month for 48 weeks.

  • PP3M 350 mg eq.Drug

    Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every third month for 48 weeks.

  • PP3M 525 mg eq.Drug

    Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every third month for 48 weeks.

  • Placebo (20% Intralipid)Drug

    Form= injection, route= intramuscular use. One injection monthly when not receiving active medication for 48 weeks.

  • PP1M 50 mg eq.Drug

    Type= exact number, unit= mg eq., number= 50, form= injection, route= intramuscular use. One injection every month for 48 weeks.

  • PP1M 75 mg eq.Drug

    Type= exact number, unit= mg eq., number= 75, form= injection, route= intramuscular use. One injection every month for 48 weeks.

  • PP1M 100 mg eq.Drug

    Type= exact number, unit= mg eq., number= 100, form= injection, route= intramuscular use. One injection every month for 48 weeks.

  • PP1M 150 mg eq.Drug

    Type= exact number, unit= mg eq., number= 150, form= injection, route= intramuscular use. One injection every month for 48 weeks.

Study groups in NCT01515423
Study groupRoleWhat they receive
Paliperidone palmitate 3-month (PP3M)ExperimentalA formulation of paliperidone palmitate with a 3-month injection interval
Receives: Drug: PP3M 175 mg eq.; Drug: PP3M 263 mg eq.; Drug: PP3M 350 mg eq.; Drug: PP3M 525 mg eq.; Drug: Placebo (20% Intralipid)
Paliperidone palmitate 1-month (PP1M)Active comparatorA formulation of paliperidone palmitate with a 1-month injection interval
Receives: Drug: PP1M 50 mg eq.; Drug: PP1M 75 mg eq.; Drug: PP1M 100 mg eq.; Drug: PP1M 150 mg eq.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase

    Relapse defined as: Psychiatric hospitalization;participant had an increase of 25 percent in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was greater than (>) 40; had a 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was less than or equal to (<=) 40; deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury;suicidal or homicidal ideation and aggressive behavior;For PANSS items-had a score of greater than or equal to (>=) 5 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was <=3 at randomization; had a score of >=6 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was 4 at randomization.

    Measured: Up to 48 weeks

Secondary outcomes (6)

  1. Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48

    The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).

    Measured: DB Baseline (Week 17) and 48 week or DB Endpoint

  2. Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48

    The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.

    Measured: DB Baseline (Week 17) and 48 week or DB Endpoint

  3. Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48

    The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100. Participants with a score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.

    Measured: DB Baseline (Week 17) and 48 week or DB Endpoint

  4. Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria

    Symptomatic remission criterion was defined as having a simultaneous score of mild or less on all selected PANSS items (P1, P2, P3, N1, N4, N6, G5, and G9). Symptomatic remission was defined for the last 6 months of the Double-blind Phase as meeting the remission criterion during the 6 months prior to the End of study visit during the Double-blind Phase, with one excursion allowed.

    Measured: Weeks 41 to 65

  5. Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48

    The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).

    Measured: DB Baseline (Week 17) and 48 week or DB Endpoint

  6. Change From Baseline in Marder Factor Subscale Score at Week 48

    5 PANSS Marder factor scores (positive symptoms [range:8 to 56], negative symptoms [range: 7 to 49], disorganized thoughts [range: 7 to 49], uncontrolled hostility/excitement [range: 4 to 28], and anxiety/depression [range: 4 to 28]) were examined to gain insight into the symptoms affected by treatment with the study drug. Negative change from baseline in subscales score for positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression indicates improvement in various symptoms of schizophrenia.

    Measured: DB Baseline (Week 17) and 48 week or DB Endpoint

Timeline

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

  1. First posted24 Jan 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionFeb 2015
  4. Study completionMar 2015

Resources

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
1,429 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01515423
Sponsor's protocol ID
CR100662
Other IDs
R092670PSY3011, 2011-004889-15, U1111-1135-7054
Status last verified
Apr 2016
First submitted
17 Jan 2012
Last updated
2 May 2016
Data monitoring committee
No

Publications

  • Li X, Ye C, Zhang W, Jia M, Wang G. Factors Associated with Symptom Stabilization that Allow for Successful Transition from Once-Monthly Paliperidone Palmitate to Three-Monthly Paliperidone Palmitate: A Post Hoc Analysis Examined Clinical Characteristics in Chinese Patients with Schizophrenia. CNS Drugs. 2024 Jan;38(1):55-65. doi: 10.1007/s40263-023-01056-x. Epub 2024 Jan 8.

    PubMed 38190077

  • Gopal S, Gogate J, Pungor K, Kim E, Singh A, Mathews M. Improvement of Negative Symptoms in Schizophrenia with Paliperidone Palmitate 1-Month and 3-Month Long-Acting Injectables: Results from a Phase 3 Non-Inferiority Study. Neuropsychiatr Dis Treat. 2020 Mar 6;16:681-690. doi: 10.2147/NDT.S226296. eCollection 2020.

    PubMed 32184607

  • Savitz AJ, Xu H, Gopal S, Nuamah I, Mathews M, Soares B. Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies. Braz J Psychiatry. 2019 Nov-Dec;41(6):499-510. doi: 10.1590/1516-4446-2018-0153.

    PubMed 30994855

  • Nash AI, Turkoz I, Savitz AJ, Mathews M, Kim E. Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation. Neuropsychiatr Dis Treat. 2019 Mar 22;15:731-737. doi: 10.2147/NDT.S194264. eCollection 2019.

    PubMed 30962688

  • Mathews M, Pei H, Savitz A, Nuamah I, Hough D, Alphs L, Gopal S. Paliperidone Palmitate 3-Monthly Versus 1-Monthly Injectable in Patients With Schizophrenia With or Without Prior Exposure to Oral Risperidone or Paliperidone: A Post Hoc, Subgroup Analysis. Clin Drug Investig. 2018 Aug;38(8):695-702. doi: 10.1007/s40261-018-0647-z.

    PubMed 29882073

  • Magnusson MO, Samtani MN, Plan EL, Jonsson EN, Rossenu S, Vermeulen A, Russu A. Population Pharmacokinetics of a Novel Once-Every 3 Months Intramuscular Formulation of Paliperidone Palmitate in Patients with Schizophrenia. Clin Pharmacokinet. 2017 Apr;56(4):421-433. doi: 10.1007/s40262-016-0459-3.

    PubMed 27743205

  • Samtani MN, Nandy P, Ravenstijn P, Remmerie B, Vermeulen A, Russu A, D'hoore P, Baum EZ, Savitz A, Gopal S, Hough D. Prospective dose selection and acceleration of paliperidone palmitate 3-month formulation development using a pharmacometric bridging strategy. Br J Clin Pharmacol. 2016 Nov;82(5):1364-1370. doi: 10.1111/bcp.13050. Epub 2016 Jul 24.

    PubMed 27333588

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PP3M 175 mg eq., PP3M 263 mg eq. and PP3M 350 mg eq. in people with Schizophrenia, run by Janssen Research & Development, LLC at 174 sites in 26 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 7 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 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 174 sites in Japan, United States, Russia, China, Poland and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 2 May 2016). 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?

Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase (time frame: Up to 48 weeks). 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 NCT01515423, 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 2 May 2016.

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