InsomniaPhase 1NCT01293006

Effects of Suvorexant in Patients With Chronic Obstructive Pulmonary Disease (MK-4305-032)

A Phase 1 study testing suvorexant in people with Insomnia, run by Merck Sharp & Dohme LLC.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Insomnia
What is being tested?: suvorexant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 25 participants
Where: No sites listed yet
Study dates: 25 Mar 2011to 22 Feb 2012
Phase: Phase 1
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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Female participants of reproductive potential must demonstrate a serum beta-human chorionic gonadotropin (β-hCG) level consistent with the nongravid state at the prestudy (screening) visit and agree to use (and/or have their partner use) two (2) acceptable methods of birth control beginning at the prestudy visit throughout the study (including washout intervals between treatment periods/panels) and until 2 weeks after the last dose of study drug in the last treatment period. Females of non-childbearing potential (postmenopausal without menses for at least 1 year and follicle stimulating hormone [FSH] value in the postmenopausal range, or status post hysterectomy, oophorectomy or tubal ligation. Documented hysterectomy or oophorectomy)
Body Mass Index (BMI) ≤40 kg/m2 at the prestudy (screening)
COPD documented by medical history and pulmonary function tests with spirometry measurements at Visit 1 meet all of the following COPD study criteria according to the modified Global Initiative for Obstructive Lung Disease (GOLD) criteria (forced expiratory volume [FEV1]/ forced vital capacity [FVC] ratio ≤70% and FEV1 ≥40% predicted [inclusive])
Stable physical health for at least 2 weeks prior to entering the study
No clinically significant abnormality on electrocardiogram (ECG)
No clinically significant abnormality on the screening polysomnography (PSG) including no evidence of obstructive sleep apnea, restless leg syndrome, periodic limb movement disorder, parasomnia including nightmare disorder, sleep terror disorder and sleepwalking disorder but participants with insomnia may be enrolled

Show all 10Show fewer

Nonsmoker or smokes ≤20 cigarettes or equivalent per day without the urge to wake up to smoke during the night
Sleeps for 4 hours or more per night with a usual bedtime between 8:00 post meridian (PM) and 12:30 ante meridian (AM)
Participant must complete a sleep diary for at least 5 consecutive days and up to 21 days prior to the screening PSG visit
Participant is reliably able to perform the study assessments; demonstrates ability to understand task instructions, and is physically capable

Who cannot join

Participant is mentally or legally incapacitated, has significant emotional problems at the time of prestudy or expected during conduct of the study, or has a history or evidence of a clinically significant psychiatric disorder that would interfere with participation in the study
Abnormal pre-randomization laboratory values in alanine transaminase (ALT >1.5 x the upper limit of normal [ULN]), aspartate transaminase (AST >1.5 x ULN), total bilirubin >1.5 x ULN, and serum creatinine of >2 mg/dL
Participant has any history of a neurological disorder, including but not limited to seizure disorder (other than single episodes of childhood febrile seizures), stroke, transient ischemic attack, multiple sclerosis, cognitive impairment, or significant head trauma with sustained loss of consciousness within the last 10 years
History of bipolar disorder, a psychotic disorder, or posttraumatic stress disorder, or psychiatric condition requiring treatment with a prohibited medication, or psychiatric condition that, in the investigator's opinion, would interfere with the patient's ability to participate in the study
Participant has other than COPD and evidence of another clinically significant, active pulmonary disorder, such as such as bronchiectasis or asthma documented by history, physical examination, or chest x-ray
History within the past 6 months prior to the prestudy of acute coronary syndrome, unstable angina, congestive heart failure, cardiogenic syncope, cardiomyopathy, any symptomatic arrhythmia, orthostatic hypotension, or uncontrolled hypertension

Show all 24Show fewer

History of neoplastic disease except adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, malignancies which have been successfully treated ≥10 years prior to the prestudy and follow-up has revealed no evidence of recurrence from the time of treatment through the time of the prestudy, or in the opinion of the Investigator, are highly unlikely to sustain a recurrence for the duration of the study
History or diagnosis of narcolepsy, cataplexy (familial or idiopathic), circadian rhythm sleep disorder, parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, and REM behavior disorder, sleep-related Breathing Disorder (i.e., obstructive or central sleep apnea syndrome or central alveolar hypoventilation syndrome), periodic limb movement disorder, restless legs syndrome, or primary hypersomnia
Normal PSG recording at screening
Hematocrit > 55%
Participant has been treated in an emergency room or has been hospitalized for COPD within 2 months prior to the screening visit, necessitating antibiotics, systemic corticosteroids, oxygen therapy
Positive screening urine alcohol test or drug test
Nursing mother
Condition, therapy, lab, or ECG abnormality or other circumstances that might confound the results of the study
Taking, or plans to take, one or more of the prohibited concomitant medications
Participant consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages, or excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day
Participant has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to the prestudy (screening) visit
History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Currently a regular user (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 2 years
Need for more than 3 toilet visits during the night
Participant has a history of shift work (defined as permanent night shift or rotating day/night shift work) within the past 2 weeks or anticipates the need to perform shift work during the study
Travel across 3 or more time zones (transmeridian travel) within 1 week of study start
Participant is at imminent risk of self-harm or harm to others in the investigator's opinion
Concerns of the investigator regarding the safe participation of the participant in the study

About this study

Official title: A Study to Evaluate the Effects of MK-4305 in Patients With Chronic Obstructive Pulmonary Disease

This study will evaluate the safety, tolerability, and effect of multiple doses of suvorexant (MK-4305) on respiratory function in participants with chronic obstructive pulmonary disease (COPD). This is a crossover study, so all participants will receive both suvorexant and placebo while on study. The primary hypothesis of this study is that multiple doses of suvorexant do not produce a clinically significant reduction of mean oxygen saturation (SaO2) during total sleep time in participants with COPD, as compared to placebo.

Conditions: Insomnia
Being tested: suvorexant, Placebo
Keywords: Pulmonary Disease, Chronic Obstructive
Medical subject headings: Sleep Initiation and Maintenance Disorders, Pulmonary Disease, Chronic Obstructive

What participants receive

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

suvorexantDrug
Also called MK-4305, SCH 900433
one tablet (30 or 40 mg suvorexant depending on participant age: 40 mg for participants <65 years of age and 30 mg for participants ≥65 years of age), orally, once daily, for 4 consecutive days
PlaceboDrug
one tablet matching suvorexant, orally, once daily, for 4 consecutive days

Study groups in NCT01293006
Study group	Role	What they receive
Suvorexant first, then placebo	Experimental	During Period 1, participants <65 years of age were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening and participants ≥65 years of age were administered a 30-mg oral dose of suvorexant once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. Receives: Drug: suvorexant; Drug: Placebo
Placebo first, then suvorexant	Experimental	During Period 1, participants <65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening and participants ≥65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening. Receives: Drug: suvorexant; Drug: Placebo

What is being measured

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

Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time
Evaluation of the effect of multiple dose suvorexant (MK-4305) on SaO2 during total sleep time as measured by pulse oximetry. Lower SaO2 values are associated with sleep impairment. Total sleep time is the total of all rapid eye movement (REM) and non-REM sleep in a sleep episode.
Measured: Day 4 of each period
Number of Participants With Adverse Events
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Measured: Up to 14 days after last dose
Number of Participants Discontinued From Study Drug Due to an AE
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Measured: Up to 15 days

Secondary outcomes (4)

Percentage of Total Sleep Time in Which SaO2 is Less Than 90%, 85% or 80%
Evaluation of the percentage of the night in which SaO2 is less than 90%, less than 85% and less than 80% following multiple dose administration of suvorexant and placebo. Lower SaO2 values are associated with sleep impairment.
Measured: Day 1 and Day 4 of each period
Mean Apnea/Hypopnea Index (AHI)
Evaluation of the effect of multiple dose administration of suvorexant on AHI as measured by polysomnography. The AHI is an overall index of obstructive sleep apnea (OSA) severity. The AHI is calculated by dividing the number of apneas and hypopneas by the number of hours of sleep. AHI values are categorized as mild OSA = 5 to <15/hr and moderate OSA = 15 to <30/hr.
Measured: Day 1 and Day 4 of each period
Mean Arterial SaO2 for Different Sleep Stages
Comparison of the mean SaO2 during different sleep stages (REM, Non-REM, and awake) following multiple dose administration of suvorexant and placebo. Lower SaO2 values are associated with sleep impairment. Sleep stages were determined by polysomnography.
Measured: Day 1 and Day 4 of each period
Mean Arterial SaO2 During Total Sleep Time
Evaluation of the effect of multiple dose suvorexant on mean oxygen saturation (SaO2) during total sleep time as measured by pulse oximetry. Lower SaO2 values are associated with sleep impairment. Total sleep time is the total of all rapid eye movement (REM) and non-REM sleep in a sleep episode.
Measured: Day 1 of each period

Timeline

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

25 Mar 201122 Feb 2012

First posted10 Feb 2011 (estimated)
Study start25 Mar 2011
Primary completion20 Jan 2012
Study completion22 Feb 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InsomniaStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01293006
Sponsor's protocol ID: 4305-032
Status last verified: Aug 2018
First submitted: 8 Feb 2011
Last updated: 21 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Sun H, Palcza J, Rosenberg R, Kryger M, Siringhaus T, Rowe J, Lines C, Wagner JA, Troyer MD. Effects of suvorexant, an orexin receptor antagonist, on breathing during sleep in patients with chronic obstructive pulmonary disease. Respir Med. 2015 Mar;109(3):416-26. doi: 10.1016/j.rmed.2014.12.010. Epub 2015 Jan 5.
PubMed 25661282

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Effects of MK-4305 in Patients With Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT01293006
Acronym / sponsor ID: 4305-032
Conditions: Insomnia
Keywords: Pulmonary Disease, Chronic Obstructive
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 25 Mar 2011 (actual)
Primary completion: 20 Jan 2012 (actual)
Study completion: 22 Feb 2012 (actual)
First posted: 10 Feb 2011 (estimated)
Results: Posted 10 Sep 2014

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Suvorexant first, then placebo	Experimental	Drug: suvorexant, Drug: PlaceboDuring Period 1, participants <65 years of age were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening and participants ≥65 years of age were administered a 30-mg oral dose of suvorexant once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
Placebo first, then suvorexant	Experimental	Drug: suvorexant, Drug: PlaceboDuring Period 1, participants <65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening and participants ≥65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Female participants of reproductive potential must demonstrate a serum beta-human chorionic gonadotropin (β-hCG) level consistent with the nongravid state at the prestudy (screening) visit and agree to use (and/or have their partner use) two (2) acceptable methods of birth control beginning at the prestudy visit throughout the study (including washout intervals between treatment periods/panels) and until 2 weeks after the last dose of study drug in the last treatment period. Females of non-childbearing potential (postmenopausal without menses for at least 1 year and follicle stimulating hormone [FSH] value in the postmenopausal range, or status post hysterectomy, oophorectomy or tubal ligation. Documented hysterectomy or oophorectomy)
Body Mass Index (BMI) ≤40 kg/m2 at the prestudy (screening)
COPD documented by medical history and pulmonary function tests with spirometry measurements at Visit 1 meet all of the following COPD study criteria according to the modified Global Initiative for Obstructive Lung Disease (GOLD) criteria (forced expiratory volume [FEV1]/ forced vital capacity [FVC] ratio ≤70% and FEV1 ≥40% predicted [inclusive])
Stable physical health for at least 2 weeks prior to entering the study
No clinically significant abnormality on electrocardiogram (ECG)

Key exclusion criteria (24 listed)

Participant is mentally or legally incapacitated, has significant emotional problems at the time of prestudy or expected during conduct of the study, or has a history or evidence of a clinically significant psychiatric disorder that would interfere with participation in the study
Abnormal pre-randomization laboratory values in alanine transaminase (ALT >1.5 x the upper limit of normal [ULN]), aspartate transaminase (AST >1.5 x ULN), total bilirubin >1.5 x ULN, and serum creatinine of >2 mg/dL
Participant has any history of a neurological disorder, including but not limited to seizure disorder (other than single episodes of childhood febrile seizures), stroke, transient ischemic attack, multiple sclerosis, cognitive impairment, or significant head trauma with sustained loss of consciousness within the last 10 years
History of bipolar disorder, a psychotic disorder, or posttraumatic stress disorder, or psychiatric condition requiring treatment with a prohibited medication, or psychiatric condition that, in the investigator's opinion, would interfere with the patient's ability to participate in the study
Participant has other than COPD and evidence of another clinically significant, active pulmonary disorder, such as such as bronchiectasis or asthma documented by history, physical examination, or chest x-ray

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
suvorexantAlso: MK-4305, SCH 900433one tablet (30 or 40 mg suvorexant depending on participant age: 40 mg for participants <65 years of age and 30 mg for participants ≥65 years of age), orally, once daily, for 4 consecutive days	Drug	Placebo first, then suvorexant, Suvorexant first, then placebo
Placeboone tablet matching suvorexant, orally, once daily, for 4 consecutive days	Drug	Placebo first, then suvorexant, Suvorexant first, then placebo

Primary outcome

Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time
Time frame: Day 4 of each period
Evaluation of the effect of multiple dose suvorexant (MK-4305) on SaO2 during total sleep time as measured by pulse oximetry. Lower SaO2 values are associated with sleep impairment. Total sleep time is the total of all rapid eye movement (REM) and non-REM sleep in a sleep episode.
Number of Participants With Adverse Events
Time frame: Up to 14 days after last dose
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Number of Participants Discontinued From Study Drug Due to an AE
Time frame: Up to 15 days
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.

4 secondary outcomes

Percentage of Total Sleep Time in Which SaO2 is Less Than 90%, 85% or 80%
Time frame: Day 1 and Day 4 of each period
Mean Apnea/Hypopnea Index (AHI)
Time frame: Day 1 and Day 4 of each period
Mean Arterial SaO2 for Different Sleep Stages
Time frame: Day 1 and Day 4 of each period
Mean Arterial SaO2 During Total Sleep Time
Time frame: Day 1 of each period

Results and safety

Results posted to the registry on 10 Sep 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
Suvorexant (40 mg) Then Placebo	11	11
Suvorexant (30 mg) Then Placebo	2	2
Placebo Then Suvorexant (40 mg)	9	9
Placebo Then Suvorexant (30 mg)	3	3

Primary outcome: Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time

Time frame: Day 4 of each period. Least squares mean (95% Confidence Interval). Unit: Percentage of Oxygen Saturation

Measure	Suvorexant (30 mg or 40 mg) n = 24	Placebo n = 22
Value	93.38 (92.47 to 94.30)	92.99 (92.06 to 93.92)

Suvorexant (30 mg or 40 mg) vs Placebo: Mean Difference (Final Values): 0.39 (90% CI -0.12 to 0.91), Difference of Least Squares Means

Population analysed: Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation. During the Placebo periods, there were 22 evaluable participants at Day 4; 2 participants had either no data or missing data.

Primary outcome: Number of Participants With Adverse Events

Time frame: Up to 14 days after last dose. Number. Unit: participants

Measure	Suvorexant (40 mg) n = 20	Suvorexant (30 mg) n = 5	Placebo n = 25
Value	6	2	5

Population analysed: All participants were included in the Safety Population.

Primary outcome: Number of Participants Discontinued From Study Drug Due to an AE

Time frame: Up to 15 days. Number. Unit: participants

Measure	Suvorexant (40 mg) n = 20	Suvorexant (30 mg) n = 5	Placebo n = 25
Value	0	0	0

Population analysed: All participants were included in the Safety Population.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 14 days after last dose. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Suvorexant (40 mg)	0 of 20 (0%)	3 of 20 (15%)	Not reported
Suvorexant (30 mg)	0 of 5 (0%)	2 of 5 (40%)	Not reported
Placebo	0 of 25 (0%)	4 of 25 (16%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25661282Sun H, Palcza J, Rosenberg R, Kryger M, Siringhaus T, Rowe J, Lines C, Wagner JA, Troyer MD. Effects of suvorexant, an orexin receptor antagonist, on breathing during sleep in patients with chronic obstructive pulmonary disease. Respir Med. 2015 Mar;109(3):416-26. doi: 10.1016/j.rmed.2014.12.010. Epub 2015 Jan 5.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing suvorexant in people with Insomnia, run by Merck Sharp & Dohme LLC.

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 10 inclusion and 24 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 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 10 Sep 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?

Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time (time frame: Day 4 of each period). The study lists 3 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 NCT01293006, 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 21 Sep 2018.