SchizophreniaPhase 3EST-S-02NCT04093518
Estradiol as add-on to Antipsychotics
A Phase 3 study testing Estradiol in people with Schizophrenia and Schizoaffective Disorder, run by Tangent Data at 1 site in Moldova.
Trial summary
The objective of the study is to evaluate the efficacy of Estradiol patch compared to placebo, as add-on to anti-psychotics in the treatment of women 38 and older with schizophrenia, schizoaffective or schizophreniform disorder. Read more about this study
- Who is it for?
- Ages 38 to 48 years, women only
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
- What is being tested?
- Estradiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteMoldova
- Study dates
- 2 Dec 2019to 1 Nov 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 38 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female above 38, up to 45 years of age, inclusive
- Willing and able to provide informed consent, after the nature of the study has been fully explained
- Current DSM-V diagnosis of schizophrenia, schizoaffective or schizophreniform disorder as confirmed by modified SCID.
- Total PANSS score > 70 and (PANSS positive subscale >15 and/or PANSS negative subscale >15)
- Must be on a stable dose of any antipsychotic drug, for at least 2 weeks prior to the baseline visit, at doses within the PORT criteria, whenever possible. Patients receiving higher doses will have their records reviewed to ensure that their dose is required and, if possible, will be stabilized on a lower dose prior to study entry.
- Patients who are physically and endocrinologically healthy,
- Not menopausal as assessed by asking patients if they are menstruating
- Inpatients or outpatients. Inpatients will be randomized 3 days or more after admission
Who cannot join
- Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
- Pregnant or breast-feeding
- Women who are menopausal.
- Patients treated with oral estrogen preparations containing estradiol greater than 30 mcg.
- Women who have known severe abnormalities in the hypothalamo-pituitary gonadal axis, thyroid disorders, severe medical conditions and disorders that would contraindicate estrogen use (breast cancer, migraine with aura or stroke)
- History of endometrial cancer or breast cancer, history of breast or uterine cancer, no history of 1st and 2nd grade family with breast or uterine cancer, vaginal bleeding between periods.
Show all 12Show fewer
- Likely allergy or sensitivity to estradiol.
- Schizoaffective disorder in the manic phase.
- At significant risk of committing suicide, or in the opinion of the Investigator, currently at imminent risk of suicide or harming others.
- Patients with a current DSM-V substance or alcohol abuse. Patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included.
- Concurrent delirium, mental retardation, drug-induced psychosis, or history of clinically significant brain trauma documented by CT or MRI.
- Patients receiving phenobarbital, phenytoin, carbamazepine, rifampicin, rifabutin, nevirapine, efavirenz, ritonavir and nelfinavir,or Hypericum perforatum.
Trial locations and contacts
1 site in 1 country.
Moldova1 site, 1 recruiting
- Recruiting
Centrul Comunitar de Sănătate Mintală Botanica
Chisinau, MD2072
Nicolae Cebotari, M.D., +373 6927 4593
About this study
Official title: A Randomized Trial Administering Estradiol Patch vs. Placebo Patch as add-on to Antipsychotics in Female Patients Above the Age of 38 With Schizophrenia, Schizoaffective or Schizophreniform Disorder
The objective of the study is to evaluate the efficacy of Estradiol patch compared to placebo, as add-on to anti-psychotics in the treatment of women 38 and older with schizophrenia, schizoaffective or schizophreniform disorder.
Read the detailed description
Several lines of evidence suggest that estrogen affects the course of schizophrenia. The onset of schizophrenia is 2-4 years later in women than in men, and women have a lower incidence of schizophrenia until menopause, after which women have an increased incidence, so that the lifetime prevalence is similar in both genders. Women are more likely to have their first schizophrenic episode during an estradiol trough in the menstrual cycle. These gender differences in the natural course of schizophrenia are well replicated and provide a major lead to understanding and treating the illness, and have led to several randomized controlled trials administering oral estradiol to patients with schizophrenia. Studies on transdermal estradiol have been more encouraging, and four RCTs, have shown that estradiol patches are efficacious in treating schizophrenia The most recent study was performed our group and showed that overall estradiol patches were efficacious with an effect size of 0.41 for total PANSS, with significant improvements in PANSS positive, negative and general-psychopathology scores. Post hoc analyses showed that the improvements in symptoms were found almost exclusively in women who were 38 and older, in whom the effect of estrogen patches vs placebo reached an effect size of 0.58 for PANSS total.
The currently proposed study is based on the post-hoc finding of improvement in participants aged 38 and above, and we will a-priori recruit women with schizophrenia 38 and above, in order to test the efficacy of 200 µg estradiol patches vs placebo in these woman.
- Being tested
- Estradiol, Placebo
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstradiolDrug
Also called trans dermal patches
2 transdermal patches to be changed twice a week for the duration of 16 weeks
PlaceboDrug
Also called trans dermal patches
2 transdermal patches to be changed twice a week for the duration of 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | Estradiol 200µg Receives: Drug: Estradiol |
| Placebo Comparator | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total PANSS scores at the end of the trial
The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms.
Measured: Change from Baseline at 16 weeks
Secondary outcomes (4)
Positive and Negative Syndrome Scale (PANSS) and general psychopathology scales
To evaluate the effects of Estradiol on Positive and Negative Syndrome Scale (PANSS)
Measured: through study, 16 weeks
Clinical Global Impression Scale-Severity (CGI-S) and Global Impression Scale-Improvement (CGI-I),
To evaluate the effects of Estradiol vs Placebo on Clinical Global Impression
Measured: through study, 16 weeks
Montgomery-Asberg Depression Rating Scale
To evaluate the effects of Estradiol on depressive symptoms
Measured: through study, 16 weeks
Rates of drop outs before the end of the trial
To evaluate the rate of drop outs
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start2 Dec 2019
- Primary completion15 Oct 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)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
- Model description
- Randomized, add-on to anti-psychotics, double blind, placebo-controlled, parallel group clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tangent Data
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute, MediStat Ltd., PCI pharma services (formerly BIOTEC SERVICES INTERNATIONAL LIMITED), S.C. IMUNOTEHNOMED S.R.L., Tangent Data Srl
- Responsible party
- Sponsor
- Investigators
- Mark Weiser, M.D., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093518
- Sponsor's protocol ID
- EST-S-02
- Acronym
- EST-S-02
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2019
- Last updated
- 26 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Angermeyer MC, Kuhn L, Goldstein JM. Gender and the course of schizophrenia: differences in treated outcomes. Schizophr Bull. 1990;16(2):293-307. doi: 10.1093/schbul/16.2.293.
PubMed 2374885Goff DC, Henderson DC, Amico E. Cigarette smoking in schizophrenia: relationship to psychopathology and medication side effects. Am J Psychiatry. 1992 Sep;149(9):1189-94. doi: 10.1176/ajp.149.9.1189.
PubMed 1503131Harrison G, Croudace T, Mason P, Glazebrook C, Medley I. Predicting the long-term outcome of schizophrenia. Psychol Med. 1996 Jul;26(4):697-705. doi: 10.1017/s0033291700037715.
PubMed 8817704Heringa SM, Begemann MJ, Goverde AJ, Sommer IE. Sex hormones and oxytocin augmentation strategies in schizophrenia: A quantitative review. Schizophr Res. 2015 Nov;168(3):603-13. doi: 10.1016/j.schres.2015.04.002. Epub 2015 Apr 23.
PubMed 25914107Jeste DV, Lindamer LA, Evans J, Lacro JP. Relationship of ethnicity and gender to schizophrenia and pharmacology of neuroleptics. Psychopharmacol Bull. 1996;32(2):243-51.
PubMed 8783894Kulkarni J, Gavrilidis E, Worsley R, Hayes E. Role of estrogen treatment in the management of schizophrenia. CNS Drugs. 2012 Jul 1;26(7):549-57. doi: 10.2165/11630660-000000000-00000.
PubMed 22626057Magharious W, Goff DC, Amico E. Relationship of gender and menstrual status to symptoms and medication side effects in patients with schizophrenia. Psychiatry Res. 1998 Feb 27;77(3):159-66. doi: 10.1016/s0165-1781(97)00137-6.
PubMed 9707298Melkersson KI, Hulting AL, Rane AJ. Dose requirement and prolactin elevation of antipsychotics in male and female patients with schizophrenia or related psychoses. Br J Clin Pharmacol. 2001 Apr;51(4):317-24. doi: 10.1046/j.1365-2125.2001.01352.x.
PubMed 11318766Opjordsmoen S. Long-term clinical outcome of schizophrenia with special reference to gender differences. Acta Psychiatr Scand. 1991 Apr;83(4):307-13. doi: 10.1111/j.1600-0447.1991.tb05545.x.
PubMed 2028808Pardridge WM, Mietus LJ. Transport of steroid hormones through the rat blood-brain barrier. Primary role of albumin-bound hormone. J Clin Invest. 1979 Jul;64(1):145-54. doi: 10.1172/JCI109433.
PubMed 447850Pinals DA, Malhotra AK, Missar CD, Pickar D, Breier A. Lack of gender differences in neuroleptic response in patients with schizophrenia. Schizophr Res. 1996 Dec 15;22(3):215-22. doi: 10.1016/s0920-9964(96)00067-9.
PubMed 9000318Seeman MV. Gender differences in the prescribing of antipsychotic drugs. Am J Psychiatry. 2004 Aug;161(8):1324-33. doi: 10.1176/appi.ajp.161.8.1324.
PubMed 15285956Szymanski S, Lieberman JA, Alvir JM, Mayerhoff D, Loebel A, Geisler S, Chakos M, Koreen A, Jody D, Kane J, et al. Gender differences in onset of illness, treatment response, course, and biologic indexes in first-episode schizophrenic patients. Am J Psychiatry. 1995 May;152(5):698-703. doi: 10.1176/ajp.152.5.698.
PubMed 7726309Torgalsboen AK. Full recovery from schizophrenia: the prognostic role of premorbid adjustment, symptoms at first admission, precipitating events and gender. Psychiatry Res. 1999 Nov 8;88(2):143-52. doi: 10.1016/s0165-1781(99)00077-3.
PubMed 10622350Usall J, Araya S, Ochoa S, Busquets E, Gost A, Marquez M; Assessment Research Group in Schizophrenia (NEDES). Gender differences in a sample of schizophrenic outpatients. Compr Psychiatry. 2001 Jul-Aug;42(4):301-5. doi: 10.1053/comp.2001.24582.
PubMed 11458304
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Administering Estradiol Patch vs. Placebo Patch as add-on to Antipsychotics in Female Patients Above the Age of 38 With Schizophrenia, Schizoaffective or Schizophreniform Disorder
- ClinicalTrials.gov ID
- NCT04093518
- Acronym / sponsor ID
- EST-S-02 / EST-S-02
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tangent DataUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute, MediStat Ltd., PCI pharma services (formerly BIOTEC SERVICES INTERNATIONAL LIMITED), S.C. IMUNOTEHNOMED S.R.L., Tangent Data Srl
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 15 Oct 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 18 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate the efficacy of Estradiol patch compared to placebo, as add-on to anti-psychotics in the treatment of women 38 and older with schizophrenia, schizoaffective or schizophreniform disorder.
Detailed description
Several lines of evidence suggest that estrogen affects the course of schizophrenia. The onset of schizophrenia is 2-4 years later in women than in men, and women have a lower incidence of schizophrenia until menopause, after which women have an increased incidence, so that the lifetime prevalence is similar in both genders. Women are more likely to have their first schizophrenic episode during an estradiol trough in the menstrual cycle. These gender differences in the natural course of schizophrenia are well replicated and provide a major lead to understanding and treating the illness, and have led to several randomized controlled trials administering oral estradiol to patients with schizophrenia. Studies on transdermal estradiol have been more encouraging, and four RCTs, have shown that estradiol patches are efficacious in treating schizophrenia The most recent study was performed our group and showed that overall estradiol patches were efficacious with an effect size of 0.41 for total PANSS, with significant improvements in PANSS positive, negative and general-psychopathology scores. Post hoc analyses showed that the improvements in symptoms were found almost exclusively in women who were 38 and older, in whom the effect of estrogen patches vs placebo reached an effect size of 0.58 for PANSS total.
The currently proposed study is based on the post-hoc finding of improvement in participants aged 38 and above, and we will a-priori recruit women with schizophrenia 38 and above, in order to test the efficacy of 200 µg estradiol patches vs placebo in these woman.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, add-on to anti-psychotics, double blind, placebo-controlled, parallel group clinical trial
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Drug: EstradiolEstradiol 200µg |
| Placebo Comparator | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 38 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female above 38, up to 45 years of age, inclusive
- Willing and able to provide informed consent, after the nature of the study has been fully explained
- Current DSM-V diagnosis of schizophrenia, schizoaffective or schizophreniform disorder as confirmed by modified SCID.
- Total PANSS score > 70 and (PANSS positive subscale >15 and/or PANSS negative subscale >15)
- Must be on a stable dose of any antipsychotic drug, for at least 2 weeks prior to the baseline visit, at doses within the PORT criteria, whenever possible. Patients receiving higher doses will have their records reviewed to ensure that their dose is required and, if possible, will be stabilized on a lower dose prior to study entry.
Key exclusion criteria (12 listed)
- Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
- Pregnant or breast-feeding
- Women who are menopausal.
- Patients treated with oral estrogen preparations containing estradiol greater than 30 mcg.
- Women who have known severe abnormalities in the hypothalamo-pituitary gonadal axis, thyroid disorders, severe medical conditions and disorders that would contraindicate estrogen use (breast cancer, migraine with aura or stroke)
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 |
|---|---|---|
| EstradiolAlso: trans dermal patches2 transdermal patches to be changed twice a week for the duration of 16 weeks | Drug | Active Comparator |
| PlaceboAlso: trans dermal patches2 transdermal patches to be changed twice a week for the duration of 16 weeks | Drug | Placebo Comparator |
Primary outcome
Change in total PANSS scores at the end of the trial
Time frame: Change from Baseline at 16 weeks
The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms.
4 secondary outcomes
Positive and Negative Syndrome Scale (PANSS) and general psychopathology scales
Time frame: through study, 16 weeks
Clinical Global Impression Scale-Severity (CGI-S) and Global Impression Scale-Improvement (CGI-I),
Time frame: through study, 16 weeks
Montgomery-Asberg Depression Rating Scale
Time frame: through study, 16 weeks
Rates of drop outs before the end of the trial
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Results publication: PubMed 2374885Angermeyer MC, Kuhn L, Goldstein JM. Gender and the course of schizophrenia: differences in treated outcomes. Schizophr Bull. 1990;16(2):293-307. doi: 10.1093/schbul/16.2.293.
- Results publication: PubMed 1503131Goff DC, Henderson DC, Amico E. Cigarette smoking in schizophrenia: relationship to psychopathology and medication side effects. Am J Psychiatry. 1992 Sep;149(9):1189-94. doi: 10.1176/ajp.149.9.1189.
- Results publication: PubMed 8817704Harrison G, Croudace T, Mason P, Glazebrook C, Medley I. Predicting the long-term outcome of schizophrenia. Psychol Med. 1996 Jul;26(4):697-705. doi: 10.1017/s0033291700037715.
- Results publication: PubMed 25914107Heringa SM, Begemann MJ, Goverde AJ, Sommer IE. Sex hormones and oxytocin augmentation strategies in schizophrenia: A quantitative review. Schizophr Res. 2015 Nov;168(3):603-13. doi: 10.1016/j.schres.2015.04.002. Epub 2015 Apr 23.
- Results publication: PubMed 8783894Jeste DV, Lindamer LA, Evans J, Lacro JP. Relationship of ethnicity and gender to schizophrenia and pharmacology of neuroleptics. Psychopharmacol Bull. 1996;32(2):243-51.
- Results publication: PubMed 22626057Kulkarni J, Gavrilidis E, Worsley R, Hayes E. Role of estrogen treatment in the management of schizophrenia. CNS Drugs. 2012 Jul 1;26(7):549-57. doi: 10.2165/11630660-000000000-00000.
- Results publication: PubMed 9707298Magharious W, Goff DC, Amico E. Relationship of gender and menstrual status to symptoms and medication side effects in patients with schizophrenia. Psychiatry Res. 1998 Feb 27;77(3):159-66. doi: 10.1016/s0165-1781(97)00137-6.
- Results publication: PubMed 11318766Melkersson KI, Hulting AL, Rane AJ. Dose requirement and prolactin elevation of antipsychotics in male and female patients with schizophrenia or related psychoses. Br J Clin Pharmacol. 2001 Apr;51(4):317-24. doi: 10.1046/j.1365-2125.2001.01352.x.
- Results publication: PubMed 2028808Opjordsmoen S. Long-term clinical outcome of schizophrenia with special reference to gender differences. Acta Psychiatr Scand. 1991 Apr;83(4):307-13. doi: 10.1111/j.1600-0447.1991.tb05545.x.
- Results publication: PubMed 447850Pardridge WM, Mietus LJ. Transport of steroid hormones through the rat blood-brain barrier. Primary role of albumin-bound hormone. J Clin Invest. 1979 Jul;64(1):145-54. doi: 10.1172/JCI109433.
- Results publication: PubMed 9000318Pinals DA, Malhotra AK, Missar CD, Pickar D, Breier A. Lack of gender differences in neuroleptic response in patients with schizophrenia. Schizophr Res. 1996 Dec 15;22(3):215-22. doi: 10.1016/s0920-9964(96)00067-9.
- Results publication: PubMed 15285956Seeman MV. Gender differences in the prescribing of antipsychotic drugs. Am J Psychiatry. 2004 Aug;161(8):1324-33. doi: 10.1176/appi.ajp.161.8.1324.
- 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. This study is not recruiting at the moment.
Mark Weiser, M.D. principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Estradiol in people with Schizophrenia and Schizoaffective Disorder, run by Tangent Data at 1 site in Moldova.
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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 26 May 2020. 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 Moldova. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paull G Radu, M.D. (+407 2323 4545, paull.radu@tangentdata.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total PANSS scores at the end of the trial (time frame: Change from Baseline at 16 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 NCT04093518, which also lists 17 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 26 May 2020.