Generalized Anxiety Disorder (GAD)Phase 2NCT01470469

SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP)

A Phase 2 study testing SPD503 (extended-release Guanfacine hydrochloride) in people with Generalized Anxiety Disorder (GAD) and Anxiety, Separation, run by Shire at 33 sites in United States.

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

This study will evaluate the safety and tolerability of SPD503 in subjects aged 6-17 years with GAD, SAD, or SoP based on treatment emergent adverse events (TEAEs), vital signs and ECGs. Read more about this study

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Generalized Anxiety Disorder (GAD), Anxiety, Separation, Phobia, Social
What is being tested?: SPD503 (extended-release Guanfacine hydrochloride)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 83 participants
Where: 33 sitesUnited States
Study dates: 4 Jan 2012to 15 Jul 2013
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 6 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Outpatient subjects aged 6-17 years inclusive at the time of consent/assent (Screening Visit [Visit 1] only).
Subject's parent or legally authorized representative (LAR) must provide signature of informed consent, and there must be documentation of assent by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidance E6 (1996) and applicable regulations before completing any study-related procedures (Screening Visit [Visit 1] only).
Subject meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) criteria for a Primary Diagnosis of 1 or any combination of the following; GAD, SAD or SoP (300.02, 309.21 and 300.23), based on a detailed psychiatric evaluation at screening including completion of the Anxiety Disorders Interview Schedule for DSM-IV Child Version (ADIS-C).
Subject has a score of >/= 4 on the Clinician Severity Rating Scale for the Principal Diagnosis on the ADIS-C CSR) at the Screening Visit (Visit 1) and the Baseline Visit (Visit 2).
Subject is functioning at an age-appropriate level intellectually, as determined by the Investigator.
Subject and parent/LAR understand, are able, willing, and likely to fully comply with the study procedures and restrictions defined in this protocol, in the opinion of the Investigator.
Subject is able to swallow intact tablets.
Subjects who are females of child-bearing potential (FOCP), defined as >/= 9 years of age or if <9 years of age are post-menarchal, must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at the Screening Visit (Visit 1) and a negative urine pregnancy test at the Baseline Visit (Visit 2) and Week 12 (Visit 11/ET). Females of child-bearing potential must abstain from sexual activity that could result in pregnancy or agree to use acceptable methods of contraception.

Who cannot join

Subject has a current co-morbid psychiatric diagnosis of a major depressive disorder, bipolar illness, psychosis, a pervasive development disorder other than Asperger's Syndrome, attention deficit hyperactivity disorder, an eating disorder, or substance abuse disorder.
Subject has an ADIS-C CSR score for any Axis I disorder that is greater than the ADIS-C CSR score for their Principal Diagnosis of GAD, SAD, or SoP.
Subject has any condition or illness which, in the opinion of the Investigator, represents an inappropriate risk to the subject and/or could confound the interpretation of the study.
Within 14 days prior to the Baseline Visit subject has received any evidence-based psychosocial intervention intended to reduce anxiety symptoms i.e. Individual Cognitive Behavioral Therapy, Group Cognitive Behavioral Therapy, or Social Effectiveness Training.
Subject has started or changed the type or intensity of a non evidence-based psychosocial intervention intended to reduce anxiety symptoms within 6 weeks prior to the Baseline Visit (Visit 2).
Subject has a known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems (e.g., clinically significant heart block), exercise-related cardiac events including syncope and pre syncope, or clinically significant bradycardia.

Show all 23Show fewer

Subject with orthostatic hypotension or a known history of controlled or uncontrolled hypertension.
Subject has a blood pressure measurement above the 95th percentile for age, sex, and height.
Subject has a history of a seizure disorder other than a single childhood febrile seizure occurring before the age of 3 years.
Subject is currently considered at risk for suicide in the opinion of the Investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator.
Subject is unable to limit caffeine intake to 2 servings per day throughout participation in the study beginning at time of informed consent/assent.
Subject has a history of alcohol or other substance abuse or dependence, as defined by DSM-IV within the last 6 months.
Clinically important abnormality on drug and alcohol screen at the Screening Visit (Visit 1) or Baseline Visit (Visit 2).
History of failure to respond to 2 adequate trials (consisting of an appropriate dose and adequate duration of therapy) of an SSRI or one trial of cognitive behavioral therapy for the treatment of GAD, SAD, or SoP.
Subject is well controlled on anxiolytic pharmacologic or non-pharmacologic therapy with acceptable tolerability.
Subject is currently using a prohibited medication or other medications, including herbal supplements that have identified anxiolytic or anxiogenic effects, that affect BP or heart rate or that have CNS effects in violation of the protocol-specified washout criteria at the Baseline Visit (Visit 2).
Subject is currently using valproic acid or any drug known to inhibit or induce CYP3A4/5 in violation of the protocol-specified washout criteria at the Baseline Visit (Visit 2).
Use of another investigational medicinal product or participation in a clinical study within 30 days prior to the Baseline Visit (Visit 2).
Subject is significantly overweight based on Center for Disease Control and Prevention body mass index (BMI)-for-age sex specific charts at the Screening Visit (Visit 1). Significantly overweight is defined as a BMI >95th percentile for this study.
Subject has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride or any components found in SPD503.
Subject is female and is pregnant or currently lactating.
Subject failed screening or was previously enrolled in this study.
Subject has another member of the same household currently participating in this study.

Trial locations and contacts

33 sites in 1 country.

City, postcode or hospital

33 sites in 1 country

United States33 sites

Atlanta Center for Medical Research
Atlanta, Georgia, 30308
FutureSearch Clinical Trials, LP
Austin, Texas, 78731
Birmingham Research Group, Inc
Birmingham, Alabama, 35216
Florida Clinical Research Center
Bradenton, Florida, 34201
Dr. Joseph H. Rodd
Carson, California, 90746
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience
Cincinnati, Ohio, 45219
University Hospitals of Cleveland Medical Center
Cleveland, Ohio, 44012
Ericksen Research and Development
Clinton, Utah, 84015
Duke University Medical Center, Duke Child and Family Study Center
Durham, North Carolina, 27705-4596
Sarkis Clinical Trials
Gainesville, Florida, 32607
NeuroScience, Inc.
Herndon, Virginia, 20170
Houston Clinical Trials LLC
Houston, Texas, 77098
Sun Valley Research
Imperial, California, 92251
Irvine Center for Clinical Research
Irvine, California, 92618
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70629
Center for Psychiatry and Behavioral Medicine, Inc
Las Vegas, Nevada, 89128
Premier Psychiatric Group, LLC
Lincoln, Nebraska, 68526
Professional Psychiatric Services
Mason, Ohio, 45040
Research Strategies of Memphis, LLC
Memphis, Tennessee, 38119
North Star Research
Middleburg Heights, Ohio, 44130
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Columbia University, NY State Psychiatric Institute
New York, New York, 10032
Weill Cornell Medical Center
New York, New York, 10065
IPS Research Company
Oklahoma City, Oklahoma, 73103
Finger Lakes Clinical Research
Rochester, New York, 14618
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307
Midwest Research Group
Saint Charles, Missouri, 63301
Sharp Mesa Vista Hospital, Clinical Research Department
San Diego, California, 92123
Institute of Behavioral Medicine, LLC
Smyrna, Georgia, 30080-6315
Richmond Behavioral Associates
Staten Island, New York, 10312
Elite Clinical Trials, Inc
Wildomar, California, 92595
Kolin Research Group
Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Tolerability of SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP).

This study will evaluate the safety and tolerability of SPD503 in subjects aged 6-17 years with GAD, SAD, or SoP based on treatment emergent adverse events (TEAEs), vital signs and ECGs.

Conditions: Generalized Anxiety Disorder (GAD), Anxiety, Separation, Phobia, Social
Being tested: SPD503 (extended-release Guanfacine hydrochloride), Placebo
Medical subject headings: Generalized Anxiety Disorder, Anxiety, Separation, Phobia, Social

What participants receive

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

SPD503 (extended-release Guanfacine hydrochloride)Drug
Also called Intuniv
Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks (6 week dose optimization and 6 week dose maintenance).
PlaceboDrug
Once-daily oral dosing in the evening for 12 weeks.

Study groups in NCT01470469
Study group	Role	What they receive
SPD503	Active comparator	Not described Receives: Drug: SPD503 (extended-release Guanfacine hydrochloride)
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.

Change From Baseline in Systolic Blood Pressure at Up to 12 Weeks
Measured: Baseline and up to 12 weeks
Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks
Measured: Baseline and up to 12 weeks
Change From Baseline in Pulse Rate at Up to 12 Weeks
Measured: Baseline and up to 12 weeks
Change From Baseline in Height at up to 12 Weeks
Measured: Baseline and up to 12 weeks
Change From Baseline in Weight at up to 12 Weeks
Measured: Baseline and up to 12 weeks
Change From Baseline in Electrocardiogram (ECG) QRS Interval at up to 12 Weeks
QRS complex is a portion of the ECG tracing that represents depolarization of the ventricular myocardium.
Measured: Baseline and up to 12 weeks
Change From Baseline in ECG QTcF Interval at up to 12 Weeks
The QT interval is the time from the start of the Q wave to the end of the T wave. It is a portion of the ECG tracing that represents the time taken for ventricular depolarisation and repolarisation. The QTcF includes a correction factor to help account for changes in heart rate.
Measured: Baseline and up to 12 weeks

Timeline

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

4 Jan 201215 Jul 2013

First posted11 Nov 2011 (estimated)
Study start4 Jan 2012
Primary completion15 Jul 2013
Study completion15 Jul 2013

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 Generalized Anxiety Disorder (GAD)Studies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01470469
Sponsor's protocol ID: SPD503-210
Status last verified: May 2021
First submitted: 9 Nov 2011
Last updated: 10 Jun 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

Strawn JR, Compton SN, Robertson B, Albano AM, Hamdani M, Rynn MA. Extended Release Guanfacine in Pediatric Anxiety Disorders: A Pilot, Randomized, Placebo-Controlled Trial. J Child Adolesc Psychopharmacol. 2017 Feb;27(1):29-37. doi: 10.1089/cap.2016.0132. Epub 2017 Feb 6.
PubMed 28165762

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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Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Tolerability of SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP).
ClinicalTrials.gov ID: NCT01470469
Acronym / sponsor ID: SPD503-210
Conditions: Generalized Anxiety Disorder (GAD), Anxiety, Separation, Phobia, Social
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 4 Jan 2012 (actual)
Primary completion: 15 Jul 2013 (actual)
Study completion: 15 Jul 2013 (actual)
First posted: 11 Nov 2011 (estimated)
Results: Posted 23 May 2014

Clinical summary

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

This study will evaluate the safety and tolerability of SPD503 in subjects aged 6-17 years with GAD, SAD, or SoP based on treatment emergent adverse events (TEAEs), vital signs and ECGs.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SPD503	Active comparator	Drug: SPD503 (extended-release Guanfacine hydrochloride)
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Outpatient subjects aged 6-17 years inclusive at the time of consent/assent (Screening Visit [Visit 1] only).
Subject's parent or legally authorized representative (LAR) must provide signature of informed consent, and there must be documentation of assent by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidance E6 (1996) and applicable regulations before completing any study-related procedures (Screening Visit [Visit 1] only).
Subject meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) criteria for a Primary Diagnosis of 1 or any combination of the following; GAD, SAD or SoP (300.02, 309.21 and 300.23), based on a detailed psychiatric evaluation at screening including completion of the Anxiety Disorders Interview Schedule for DSM-IV Child Version (ADIS-C).
Subject has a score of >/= 4 on the Clinician Severity Rating Scale for the Principal Diagnosis on the ADIS-C CSR) at the Screening Visit (Visit 1) and the Baseline Visit (Visit 2).
Subject is functioning at an age-appropriate level intellectually, as determined by the Investigator.

Key exclusion criteria (23 listed)

Subject has a current co-morbid psychiatric diagnosis of a major depressive disorder, bipolar illness, psychosis, a pervasive development disorder other than Asperger's Syndrome, attention deficit hyperactivity disorder, an eating disorder, or substance abuse disorder.
Subject has an ADIS-C CSR score for any Axis I disorder that is greater than the ADIS-C CSR score for their Principal Diagnosis of GAD, SAD, or SoP.
Subject has any condition or illness which, in the opinion of the Investigator, represents an inappropriate risk to the subject and/or could confound the interpretation of the study.
Within 14 days prior to the Baseline Visit subject has received any evidence-based psychosocial intervention intended to reduce anxiety symptoms i.e. Individual Cognitive Behavioral Therapy, Group Cognitive Behavioral Therapy, or Social Effectiveness Training.
Subject has started or changed the type or intensity of a non evidence-based psychosocial intervention intended to reduce anxiety symptoms within 6 weeks prior to the Baseline Visit (Visit 2).

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
SPD503 (extended-release Guanfacine hydrochloride)Also: IntunivOnce-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks (6 week dose optimization and 6 week dose maintenance).	Drug	SPD503
PlaceboOnce-daily oral dosing in the evening for 12 weeks.	Drug	Placebo

Primary outcome

Change From Baseline in Systolic Blood Pressure at Up to 12 Weeks
Time frame: Baseline and up to 12 weeks
Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks
Time frame: Baseline and up to 12 weeks
Change From Baseline in Pulse Rate at Up to 12 Weeks
Time frame: Baseline and up to 12 weeks
Change From Baseline in Height at up to 12 Weeks
Time frame: Baseline and up to 12 weeks
Change From Baseline in Weight at up to 12 Weeks
Time frame: Baseline and up to 12 weeks
Change From Baseline in Electrocardiogram (ECG) QRS Interval at up to 12 Weeks
Time frame: Baseline and up to 12 weeks
QRS complex is a portion of the ECG tracing that represents depolarization of the ventricular myocardium.
Change From Baseline in ECG QTcF Interval at up to 12 Weeks
Time frame: Baseline and up to 12 weeks
The QT interval is the time from the start of the Q wave to the end of the T wave. It is a portion of the ECG tracing that represents the time taken for ventricular depolarisation and repolarisation. The QTcF includes a correction factor to help account for changes in heart rate.

Results and safety

Results posted to the registry on 23 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PLACEBO	21	11
SPD503	62	38

Primary outcome: Change From Baseline in Systolic Blood Pressure at Up to 12 Weeks

Time frame: Baseline and up to 12 weeks. Mean (Standard Deviation). Unit: mmHg

Measure	PLACEBO n = 19	SPD503 n = 59
Value	-1.7 (11.18)	-2.3 (11.40)

Population analysed: Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Primary outcome: Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks

Time frame: Baseline and up to 12 weeks. Mean (Standard Deviation). Unit: mmHg

Measure	PLACEBO n = 19	SPD503 n = 59
Value	0.9 (7.37)	-1.3 (9.09)

Population analysed: Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Primary outcome: Change From Baseline in Pulse Rate at Up to 12 Weeks

Time frame: Baseline and up to 12 weeks. Mean (Standard Deviation). Unit: beats/min

Measure	PLACEBO n = 19	SPD503 n = 59
Value	-0.5 (11.09)	-1.8 (11.54)

Population analysed: Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Primary outcome: Change From Baseline in Height at up to 12 Weeks

Time frame: Baseline and up to 12 weeks. Mean (Standard Deviation). Unit: cm

Measure	PLACEBO n = 19	SPD503 n = 59
Value	0.5 (0.91)	1.0 (1.79)

Population analysed: Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PLACEBO	0 of 21 (0%)	10 of 21 (47.6%)	Not reported
SPD503	0 of 62 (0%)	48 of 62 (77.4%)	Not reported

Limitations and caveats (from the sponsor): Efficacy endpoints were exploratory. No statistical testing was performed because the study was not powered.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28165762Strawn JR, Compton SN, Robertson B, Albano AM, Hamdani M, Rynn MA. Extended Release Guanfacine in Pediatric Anxiety Disorders: A Pilot, Randomized, Placebo-Controlled Trial. J Child Adolesc Psychopharmacol. 2017 Feb;27(1):29-37. doi: 10.1089/cap.2016.0132. Epub 2017 Feb 6.

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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.

Study Director study director

Takeda

33 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 SPD503 (extended-release Guanfacine hydrochloride) in people with Generalized Anxiety Disorder (GAD) and Anxiety, Separation, run by Shire at 33 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 8 inclusion and 23 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 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 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 23 May 2014). 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 Baseline in Systolic Blood Pressure at Up to 12 Weeks (time frame: Baseline and up to 12 weeks). The study lists 7 primary outcomes in all. 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 NCT01470469, 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 10 Jun 2021.