Parkinson's DiseasePhase 4NCT00489255
Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment
A Phase 4 study testing Tigan® in people with Parkinson's Disease, run by Ipsen at 27 sites in United States.
Trial summary
The purposes of the study are to determine: i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with Apokyn® (apomorphine) ii. To determine the optimal duration for continuation of Tigan® following initiation of Apokyn® therapy iii. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Tigan®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 27 sitesUnited States
- Study dates
- May 2007to Mar 2012
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18 years or over
- Subjects with advanced Parkinson's disease with disabling hypomobility ("off" episodes) who are to be initiated with Apokyn® by intermittent subcutaneous injection
- Able to swallow Tigan®/placebo capsules
- Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- Women of child bearing potential must have a negative serum pregnancy test (beta hCG) prior to receiving study drug and must be using an appropriate form of contraception
- Willing and able to provide informed consent
Who cannot join
- Hypersensitive to apomorphine hydrochloride or any of the ingredients of Apokyn® (notably sodium metabisulfite)
- Hypersensitive to trimethobenzamide or any of the ingredients of Tigan®
- Previous treatment with Apokyn®
- Participation in any other clinical trial within 14 days of the present trial
- Contraindications to Apokyn® or Tigan®
- Currently taking, or likely to need to take at any time during the course of the study, any 5HT3 antagonist (ondansetron, alosetron, granisetron, palonosetron or dolasetron)
Show all 10Show fewer
- Malignant melanoma or a history of previously treated malignant melanoma
- Pregnancy or breast feeding
- Receipt of any investigational (i.e. unapproved) medication within 30 days of starting the present trial
- Any significant medical disorder, condition, concomitant medication or psychiatric disorder according to DSM-IV criteria which would, in the opinion of the investigator, represent a hazard to the subject or prevent the subject from completing the trial
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Emory University
Atlanta, Georgia, 30322
Quest Research Institute
Bingham Farms, Michigan, 48025
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Neurological Institute, Cleveland Clinic
Cleveland, Ohio, 44195
Parkinson's Disease and Movement Disorders Center of Long Island
Commack, New York, 11725
Neurology Specialist of Dallas P.A
Dallas, Texas, 75231
Iowa Health Physicians
Des Moines, Iowa, 50309
Parkinson's & Movements Disorders Center of Maryland
Elkridge, Maryland, 21075
Neurology at Shands Medical Center
Gainesville, Florida, 32608
NorthShore University Health System
Glenview, Illinois, 60026
Parkinson's Disease and Movement Disorders Center, Baylor College of Medicine
Houston, Texas, 77030
University of Florida at Jacksonville
Jacksonville, Florida, 32209
Kingston Neurological Associates
Kingston, New York, 12401
Coastal Neurological Medical Group Inc.
La Jolla, California, 78258
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174
Barrow Neurological Movement Disorder Clinic
Phoenix, Arizona, 85013
Charlotte Neurological Services
Port Charlotte, Florida, 33952
Raleigh Neurology Associates
Raleigh, North Carolina, 27607
Neurosearch, Inc.
Reseda, California, 91335
Neurology Associates, P.A.
San Antonio, Texas, 78258
Mayo Clinic
Scottsdale, Arizona, 85259
Henry Ford Health System - Franklin Point
Southfield, Michigan, 48034
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33701
USF Parkinson's Disease and Movement Disorders Center of Excellence
Tampa, Florida, 33606
East Texas Medical Center
Tyler, Texas, 75701
Neurosearch II, Inc.
Ventura, California, 93003
Sentara Neurological Associates
Virginia Beach, Virginia, 23456
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Trimethobenzamide (Tigan®) in the Control of Nausea and Vomiting During Initiation and Continued Treatment With Subcutaneous Apomorphine (Apokyn®) in Apomorphine-naïve Subjects With Parkinson's Disease Suffering From Acute Intermittent "Off" Episodes, With Phased Withdrawal of Subjects From Tigan® to Placebo
The purposes of the study are to determine:
- To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with Apokyn® (apomorphine) ii. To determine the optimal duration for continuation of Tigan® following initiation of Apokyn® therapy iii. To assess the safety of Tigan® in combination with Apokyn® iv. To characterize the pharmacokinetic (PK) profile of apomorphine in subjects treated concomitantly with and without Tigan®
Read the detailed description
Initial randomization is Tigan or Placebo (3:1) with phased withdrawal of Tigan to Placebo after 4 and 8 weeks. Subjects completing 4 weeks Tigan re-randomized to Tigan or Placebo (2:1) with patients completing 8 weeks Tigan re-randomized to receive Tigan or Placebo (1:1). Subjects randomized to Placebo over the previous 4 weeks assigned to continue on Placebo for the remainder of the study.
- Conditions
- Parkinson's Disease
- Being tested
- Tigan®, Placebo
- Keywords
- Parkinson's disease, Anti-emetic, Nausea, Vomiting
- Medical subject headings
- Parkinson Disease, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tigan®Drug
Oral capsule, 300mg three times daily
PlaceboDrug
Oral capsule, three times daily
| Study group | Role | What they receive |
|---|---|---|
| Trimethobenzamide (Tigan®) | Experimental | Not described Receives: Drug: Tigan® |
| Inactive substance | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1
Measured: Day 1 (Period 1, Visit 2)
Secondary outcomes (21)
Incidence of Nausea and/or Vomiting for Period 1
Measured: Days 1-28
Incidence of Nausea and/or Vomiting for Period 2
Measured: Days 29-56
Incidence of Nausea and/or Vomiting for Period 3
Measured: Days 57-84
Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 1
The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.
Measured: Days 1-28
Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 2
The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.
Measured: Days 29-56
Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 3
The INVR is an 8-item, 5 point Likert-type measurement of the patient's perceived experience of nausea, vomiting and retching. Modified INVR scores collected once daily, rather than twice a day. INVR total score range from 0 to 32, with 32 indicative of the worst and 0 no symptom.
Measured: Days 57-84
Subject Global Evaluation of Randomized Study Medication for Period 1
The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question "Overall, how would you rate the study medication you received for nausea/vomiting?" Response choices were excellent, very good, good, fair, or poor.
Measured: Day 28 (Visit 3)
Subject Global Evaluation of Randomized Study Medication for Period 2
The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question "Overall, how would you rate the study medication you received for nausea/vomiting?" Response choices were excellent, very good, good, fair, or poor.
Measured: Day 56 (Visit 4)
Subject Global Evaluation of Randomized Study Medication for Period 3
The subject global evaluation of Tigan/placebo was completed by the subject at the visits in response to the question "Overall, how would you rate the study medication you received for nausea/vomiting?" Response choices were excellent, very good, good, fair, or poor.
Measured: Day 84 (Visit 5)
Median Time to 'on' for Visit 2/Period 1 Injection 1
Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.
Measured: Day 1 (Visit 2)
Median Time to 'on' for Visit 2/Period 1 Injection 2
Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.
Measured: Day 1 (Visit 2)
Median Time to 'on' for Visit 3/End of Period 1 Injection
Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.
Measured: Day 28
Median Time to 'on' for Visit 4/End of Period 2 Injection
Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.
Measured: Day 56 (Visit 4)
Median Time to 'on' for Visit 5/End of Period 3 Injection
Time to "on" (relief of immobility) was measured 20 minutes after administration of Apokyn and before discharge at the clinic; calculated as the difference between the recorded time of "on" and time of injection.
Measured: Day 84 (Visit 5)
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 2, Pre Apokyn Dose, Period 1
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Measured: Day 1 (Visit 2)
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Pre Apokyn Dose, Period 1
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Measured: Day 28
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Post Apokyn Dose, Period 1
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Measured: Day 28
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Pre Apokyn Dose, Period 2
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Measured: Day 56 (Visit 4)
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Post Apokyn Dose, Period 2
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Measured: Day 56 (Visit 4)
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Pre Apokyn Dose, Period 3
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Measured: Day 84 (Visit 5)
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Post Apokyn Dose, Period 3
Part 3 (Motor Examination) of the UPDRS contains 14 items designed to assess the severity of the cardinal motor findings (e.g., tremor, rigidity, bradykinesia, postural instability, etc.) in patients with Parkinson's disease. UPDRS motor score range from 0 to 56, with 56 indicative of the worst and 0 no disability.
Measured: Day 56 (Visit 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2011
- Study completionMar 2012
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.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INC Research Limited
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489255
- Sponsor's protocol ID
- Y-47-52844-003
- Other IDs
- APO-4PD-01
- Status last verified
- Jan 2019
- First submitted
- 20 Jun 2007
- Last updated
- 30 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Trimethobenzamide (Tigan®) in the Control of Nausea and Vomiting During Initiation and Continued Treatment With Subcutaneous Apomorphine (Apokyn®) in Apomorphine-naïve Subjects With Parkinson's Disease Suffering From Acute Intermittent "Off" Episodes, With Phased Withdrawal of Subjects From Tigan® to Placebo
- ClinicalTrials.gov ID
- NCT00489255
- Acronym / sponsor ID
- Y-47-52844-003
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Anti-emetic, Nausea, Vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Collaborators
- INC Research Limited
- Study start
- May 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 Jun 2007 (estimated)
- Results
- Posted 20 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of the study are to determine:
- To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with Apokyn® (apomorphine) ii. To determine the optimal duration for continuation of Tigan® following initiation of Apokyn® therapy iii. To assess the safety of Tigan® in combination with Apokyn® iv. To characterize the pharmacokinetic (PK) profile of apomorphine in subjects treated concomitantly with and without Tigan®
Detailed description
Initial randomization is Tigan or Placebo (3:1) with phased withdrawal of Tigan to Placebo after 4 and 8 weeks. Subjects completing 4 weeks Tigan re-randomized to Tigan or Placebo (2:1) with patients completing 8 weeks Tigan re-randomized to receive Tigan or Placebo (1:1). Subjects randomized to Placebo over the previous 4 weeks assigned to continue on Placebo for the remainder of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trimethobenzamide (Tigan®) | Experimental | Drug: Tigan® |
| Inactive substance | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects aged 18 years or over
- Subjects with advanced Parkinson's disease with disabling hypomobility ("off" episodes) who are to be initiated with Apokyn® by intermittent subcutaneous injection
- Able to swallow Tigan®/placebo capsules
- Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- Women of child bearing potential must have a negative serum pregnancy test (beta hCG) prior to receiving study drug and must be using an appropriate form of contraception
Key exclusion criteria (10 listed)
- Hypersensitive to apomorphine hydrochloride or any of the ingredients of Apokyn® (notably sodium metabisulfite)
- Hypersensitive to trimethobenzamide or any of the ingredients of Tigan®
- Previous treatment with Apokyn®
- Participation in any other clinical trial within 14 days of the present trial
- Contraindications to Apokyn® or Tigan®
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 |
|---|---|---|
| Tigan®Oral capsule, 300mg three times daily | Drug | Trimethobenzamide (Tigan®) |
| PlaceboOral capsule, three times daily | Drug | Inactive substance |
Primary outcome
Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1
Time frame: Day 1 (Period 1, Visit 2)
21 secondary outcomes
Incidence of Nausea and/or Vomiting for Period 1
Time frame: Days 1-28
Incidence of Nausea and/or Vomiting for Period 2
Time frame: Days 29-56
Incidence of Nausea and/or Vomiting for Period 3
Time frame: Days 57-84
Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 1
Time frame: Days 1-28
Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 2
Time frame: Days 29-56
Modified Index of Nausea, Vomiting and Retching (INVR) Scores - Total Experience Score for Period 3
Time frame: Days 57-84
Subject Global Evaluation of Randomized Study Medication for Period 1
Time frame: Day 28 (Visit 3)
Subject Global Evaluation of Randomized Study Medication for Period 2
Time frame: Day 56 (Visit 4)
Subject Global Evaluation of Randomized Study Medication for Period 3
Time frame: Day 84 (Visit 5)
Median Time to 'on' for Visit 2/Period 1 Injection 1
Time frame: Day 1 (Visit 2)
Median Time to 'on' for Visit 2/Period 1 Injection 2
Time frame: Day 1 (Visit 2)
Median Time to 'on' for Visit 3/End of Period 1 Injection
Time frame: Day 28
Median Time to 'on' for Visit 4/End of Period 2 Injection
Time frame: Day 56 (Visit 4)
Median Time to 'on' for Visit 5/End of Period 3 Injection
Time frame: Day 84 (Visit 5)
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 2, Pre Apokyn Dose, Period 1
Time frame: Day 1 (Visit 2)
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Pre Apokyn Dose, Period 1
Time frame: Day 28
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 3, Post Apokyn Dose, Period 1
Time frame: Day 28
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Pre Apokyn Dose, Period 2
Time frame: Day 56 (Visit 4)
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 4, Post Apokyn Dose, Period 2
Time frame: Day 56 (Visit 4)
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Pre Apokyn Dose, Period 3
Time frame: Day 84 (Visit 5)
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 (Motor Section) for Visit 5, Post Apokyn Dose, Period 3
Time frame: Day 56 (Visit 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ipsen Medical Director study director
Ipsen
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tigan® in people with Parkinson's Disease, run by Ipsen at 27 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 6 inclusion and 10 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 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 20 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Nausea and/or Vomiting During the Initial Titration of Apokyn® at the Visit on Day 1 (time frame: Day 1 (Period 1, Visit 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2019.