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EpilepsyPhase 4NCT00522418

Study Comparing Best Medical Practice With or Without VNS Therapy in Pharmacoresistant Partial Epilepsy Patients

A Phase 4 study testing Vagal Nerve Simulation (VNS) Therapy and Best Medical Practive in people with Epilepsy and Partial Epilepsy, run by Cyberonics, Inc. at 48 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmacoresistant partial epilepsy. Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
Epilepsy, Partial Epilepsy
What is being tested?
Vagal Nerve Simulation (VNS) Therapy and Best Medical Practive
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
48 sitesin 10 countries
Study dates
Feb 2006to Jul 2008
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 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Patient has confirmed partial onset seizures.
  • Seizure activity is not adequately controlled by patient's current AED regimen.
  • Patient is between 16 and 75 years of age.
  • Patient is able to give accurate seizure counts and health outcomes information. Patient is able to complete study instruments with minimal assistance.
  • Patient has previously failed at least 3 AEDs in single or combination use.
  • During baseline evaluation period, patient should take at least 1 AED.
Show all 10Show fewer
  • Patient should have confirmed epilepsy for a minimum of 2 years.
  • Patient's AED regimen is stable for at least 1 month prior to enrolment.
  • Patient has at least 1 objective partial onset seizure per month during the 2 months prior to enrolment.
  • Patient or legal guardian understands study procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies.

Who cannot join

  • Patient has pseudoseizures or a history of pseudoseizures.
  • Patient has idiopathic generalised epilepsy or unclassified epilepsy.
  • Patient has ever received direct brain stimulation (cerebella or thalamic) for treatment of epilepsy.
  • Patient has had a unilateral or bilateral cervical vagotomy.
  • Patient has a history of non-compliance with the completion of a seizure diary.
  • Patient has taken an investigational drug within a period of 3 months prior to inclusion.
Show all 11Show fewer
  • Patient is currently using another investigational medical device.
  • Patient has a significant cardiac or pulmonary condition currently under treatment.
  • Patient has previously undergone brain surgery.
  • Patient has a demand cardiac pacemaker, implantable defibrillator, or other implantable stimulator.
  • Patient currently lives more than 2 hours from the study site or plans to relocate to a location more than 2 hours from the study site within one year of enrolment in the Study.

Trial locations and contacts

48 sites in 10 countries.

48 sites in 10 countries

Italy10 sites

  • Azienda Ospedaliero Universitaria - Ospedali Riuniti Umberto I - Lancisi - Salesi, NeuroPsichiatria Infantile

    Ancona, 60100

  • Universita di Bologna, Clinica Neurologica

    Bologna, 40123

  • Azienda Ospendaliero-Universitaria, Caressi Dep Neuroscience

    Florence, 50100

  • Ospedale San Paolo, Centro Epilessia

    Milan, 20142

  • Universita degli Studi di Cagliari - Policlinico Monserrato, Clinica Neurologica

    Monserrato, 09042

  • Universita di Pisa, Clinica Neurologica

    Pisa, 56126

  • Ospedale F. Lotti, NeuroFisioPatalogia

    Pontedera, 56025

  • Azienda Ospedaliera "Bianchi Melacrino Morelli", Centro Regionale Epilessie

    Reggio Calabria, 89100

  • Università Cattolica Del Sacro Cuore, Istituto di NeuroChirurgia

    Roma, 00168

  • Centro Epilessia, Dipartimento di Neuroscienze

    Torino, 10126

Other trials in Italy

France7 sites

  • CHU Grenoble, Neurology Department

    Grenoble, 38043

  • Hopital Roger Salengro, Service de Neurologie

    Lille, 59037

  • Hôpital Neurologique, Untité d'épileptologie

    Lyon, 69003

  • Hôpital Gui De Chauliac, Service Explorations Neurologiques et Epileptologie

    Montpellier, 34295

  • Hôpital Sainte-Anne, Service de Neurochirurgie

    Paris, 75674

  • Service d'exploration des épilepsies

    Strasbourg, 67091

  • CHU Tours, Service de neurologie

    Tours, 37044

Other trials in France

Germany6 sites

  • Universitätskliniken Bonn, Klinik für Epileptologie

    Bonn, 53105

  • Universitätsklinik Erlangen, Zentrum für Epilepsie ZEE

    Erlangen, 91054

  • Klinik der Ernst-Moritz-Arndt-Universität, Neurologische Klinik

    Greifswald, 17487

  • Epilepsiezentrum Kork

    Kehl-Kork, 77694

  • Klinikum der Philips-Universität Marburg, Fachbereich, 20 - Medizin / Klinik Neurologie / Epilepsie Zentrum

    Marburg, 35039

  • Sächsisches Epilepsiezentrum Radeberg, Epilepsiezentrum Kleinwachau

    Radeberg, 01465

Other trials in Germany

Netherlands5 sites

  • Tergooiziekenhuizen, Dienst Neurologie

    Blaricum, 1261, AN

  • Medisch Spectrum Twente, Dienst Neurologie

    Enschede, 7513 R

  • Stichting Epilepsie Instituut Nederland, Dienst Neurologie

    Heemstede, 8025 BV

  • Kempenhaeghe, Dienst Neurologie

    Oosterhout, 4901 ZG

  • Medisch Centrum Rijnmond-Zuid, locatie Clara, Dienst Neurologie

    Rotterdam, 3078 HT

Other trials in Netherlands

Spain5 sites

  • Hospital Ruber Internacional, Servicio de neurología

    Madrid, 28034

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706

  • Hospital Clínico Universitario, Servicio de neurología

    Valencia, 46010

  • Hospital General de Valencia, Neurology/Neurophisiology

    Valencia, 46014

  • Hospital General Basico De La Defensa de Valencia, Servicio de neurología

    Valencia, 46930

Other trials in Spain

Canada4 sites

  • Foothills Hospital, Neurology Department

    Calgary, Alberta, T1Y6J4

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

  • Hopital Notre Dame

    Montreal, Quebec, H2L 4M1

  • Montreal Neurological Institute, Clinical Research

    Montreal, Quebec, H3A 2B4

Other trials in Canada

Sweden4 sites

  • Institute of Neuroscience and Physiology, Clinical Neuroscience and Rehabilitation

    Gothenburg, 41345

  • Universitetssjukhuset i Lund, Neurologiska kliniken

    Lund, 221 85

  • Norrlands Universitetssjukhus, Neurocentrum

    Umeå, 901 85

  • Akademiska sjukhuset, Neurocentrum

    Uppsala, 751 85

Other trials in Sweden

United Kingdom4 sites

  • Addenbrookes Hospital, Dept of Neurosurgery

    Cambridge, CB2 2QQ

  • Walton Centre, Dept of Neurosciences, Clinical Sciences Centre

    Fazakerley, L97LJ

  • Kings College Hospital, Dept of Neurosurgery

    London, SE5 9RS

  • National Hospital for Neurology and Neurosurgery

    London, WC1N3B

Other trials in United Kingdom

Belgium2 sites

  • ULB-Hôpital Erasme, Centre de référence pour le traitement de l'épilepsie réfractaire - Neurologie

    Brussels, 1070

  • UZ Gent, Department of Neurology, 1K12/A

    Ghent, 9000

Other trials in Belgium

Norway1 site

  • Spesialsykehuset for Epilepsi, Dep of Neurodiagnostics

    Sandvika, 1306

Other trials in Norway

About this study

Official title: An Open Prospective Randomised Long-Term Effectiveness Study, Comparing Best Medical Practice With or Without Adjunctive VNS Therapy in Patients 16 Years and Older With Pharmaco-resistant Partial Epilepsy

This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmacoresistant partial epilepsy.

Read the detailed description

This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmaco-resistant partial epilepsy. The Sponsor, Cyberonics, provides funding for this study. Patients are followed for 26 months, 24 of those months are following the initiation of treatment. No study sites will be permitted to enroll study subjects until Institutional Review Board (IRB)/Ethics Committee (EC) approval has been received.

Being tested
Vagal Nerve Simulation (VNS) Therapy, Best Medical Practive
Keywords
Epilepsy, VNS Therapy
Medical subject headings
Epilepsy, Epilepsies, Partial

What participants receive

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

  • Vagal Nerve Simulation (VNS) TherapyDevice

    VNS Therapy + Best Medical Practice including anti-epileptic drugs

  • Best Medical PractiveDrug

    Best Medical Practice including anti-Epileptic Drugs

Study groups in NCT00522418
Study groupRoleWhat they receive
VNS TherapyExperimentalVNS Therapy + Best Medical Practice
Receives: Device: Vagal Nerve Simulation (VNS) Therapy
Best Medical PracticeActive comparatorBest Medical Practice
Receives: Drug: Best Medical Practive

What is being measured

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

  1. Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment

    QOLIE-89 contains 17 multi-item measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, attention/concentration, language, memory, physical function, pain, role limitations due to physical problems, and health perceptions. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.

    Measured: Mean change from baseline QOLIE-89 Overall Score at 12 months

Secondary outcomes (21)

  1. Response Rate

    Response Rate is defined as the percent of participants who are responders. A Responder is defined as participants with a reduction of at least 50% or 75% in seizure frequency from baseline to the seizure count evaluation period.

    Measured: Number of Responders at 12 Months

  2. Percent of Patients That Are Seizure Free

    Percent of patients that are seizure free as defined by no seizures during the preceding follow-up period.

    Measured: 3, 6, 9, 12, 15, 18, 21, 24 months

  3. Mean Percent Change in Seizure Frequency

    Percent change in total seizuires per week from baseline at 12 months

    Measured: Mean percent change from baseline in seizure frequency at 12 months

  4. Seizure Free Days

    Seizure free days is defined as the time from last seizure to study exit date.

    Measured: From the patient's last seizure to the study exit date

  5. Seizure Free Days Over the Last 6 Months

    Measured: Over the last 6 months

  6. Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score

    The Center for Epidemiologic Studies Depression Scale (CES-D) includes 20 items comprising six scales reflecting major dimensions of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Possible range of scores is 0 to 60, higher scores indicate more depressive symptoms.

    Measured: Mean change from baseline CES-D Score at 12 months

  7. Change From Baseline in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score

    The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 to 24, with higher scores indicating more depressive symptoms.

    Measured: Mean change from baseline NDDI-E Score at 12 months

  8. Mean Change From Beginning of Intervention Clinical Global Impression-Improvement Scale (CGI-I) Score at 12 Months

    The Clinical Global Impression scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention Scores range from 1-7: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.

    Measured: Mean change from baseline CGI-I Score at 12 months

  9. Change From Baseline in Adverse Event Profile (AEP) Score

    Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.

    Measured: Mean change from baseline AEP Score at 12 months

  10. Changes in Anti-epileptic Drugs (AEDs)

    Change from baseline in number of AED medications by visit

    Measured: Change from baseline in number of AEDs at 12 months

  11. Retention Rate

    Percent of participants who were compliant with the protocol.

    Measured: At 12 and 24 months

  12. Treatment Emergent Adverse Events, Device Complications, and Premature Study Withdrawal

    Number of participants with treatment emergent adverse events, device complications, and premature Study withdrawal.

    Measured: At 12 and 24 months

  13. Quality of Life in Epilepsy - 89 Items(QOLIE-89)in Patients With Less Than a 50% Reduction in Seizures

    QOLIE-89 contains 17 multi-item measures of overall quality of life, emotional well-being, role limitations due to emotional problems, social support, social isolation, energy/fatigue, worry about seizure, medication effects, health discouragement, work/driving/social function, attention/concentration, language, memory, physical function, pain, role limitations due to physical problems, and health perceptions. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.

    Measured: At 12 and 24 months

  14. Centre for Epidemiologic Studies Depression Scale (CES-D) in Patients With Less Then a 50% Reduction

    The Center for Epidemiologic Studies Depression Scale (CES-D) includes 20 items comprising six scales reflecting major dimensions of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Possible range of scores is 0 to 60, higher scores indicate more depressive symptoms.

    Measured: At 12 and 24 months

  15. Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) in Patients With Less Then a 50% Reduction in Seizures

    The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 to 24, with higher scores indicating more depressive symptoms.

    Measured: At 12 and 24 months

  16. Adverse Event Profile (AEP) in Patients With Less Then a 50% Reduction in Seizures

    Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.

    Measured: At 12 and 24 months

  17. Change in the Number of Anti-epileptic Drugs Prescribed

    Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures

    Measured: At 12 and 24 months

  18. Percent of Participants Who Were Compliant With the Protocol

    Retention rate in patients with less then a 50% reduction in seizures

    Measured: At 12 and 24 months

  19. Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score >= 40

    QOLIE-89 contains 17 multi-item measures of overall quality of life. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.

    Measured: Change from baseline up to 12 months

  20. Change From Baseline in QOLIE-89 Measures: Subgroup Analysis of Population With Baseline Adverse Event Profile Score < 40

    QOLIE-89 contains 17 multi-item measures of overall quality of life. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. Adverse Events Profile (AEP) is a 19-item scale used as a systematic measure of adverse effects from antiepileptic drugs (AEDs). Scores range from 19-76; higher scores indicate high prevelance and severity of adverse events.

    Measured: Change from baseline up to 12 months

  21. Clinical Global Impressions Scale (CGI) in Patients With Less Then a 50% Reduction in Seizures

    The Clinical Global Impression scale (CGI-I)is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention Scores range from 1-7: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.

    Measured: At 12 and 24 months

Timeline

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

  1. First posted29 Aug 2007 (estimated)
  2. Study startFeb 2006
  3. Primary completionJul 2008
  4. Study completionJul 2008

Why it stopped: Insufficient enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00522418
Sponsor's protocol ID
E-100
Status last verified
Oct 2012
First submitted
27 Aug 2007
Last updated
26 Jan 2015
Data monitoring committee
Yes

Publications

  • Gilliam F. Optimizing health outcomes in active epilepsy. Neurology. 2002 Apr 23;58(8 Suppl 5):S9-20. doi: 10.1212/wnl.58.8_suppl_5.s9.

    PubMed 11971128

  • Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.

    PubMed 10660394

  • Sillanpaa M, Jalava M, Kaleva O, Shinnar S. Long-term prognosis of seizures with onset in childhood. N Engl J Med. 1998 Jun 11;338(24):1715-22. doi: 10.1056/NEJM199806113382402.

    PubMed 9624191

  • Mattson RH, Cramer JA, Collins JF, Smith DB, Delgado-Escueta AV, Browne TR, Williamson PD, Treiman DM, McNamara JO, McCutchen CB, et al. Comparison of carbamazepine, phenobarbital, phenytoin, and primidone in partial and secondarily generalized tonic-clonic seizures. N Engl J Med. 1985 Jul 18;313(3):145-51. doi: 10.1056/NEJM198507183130303.

    PubMed 3925335

  • Mattson RH, Cramer JA, Collins JF. A comparison of valproate with carbamazepine for the treatment of complex partial seizures and secondarily generalized tonic-clonic seizures in adults. The Department of Veterans Affairs Epilepsy Cooperative Study No. 264 Group. N Engl J Med. 1992 Sep 10;327(11):765-71. doi: 10.1056/NEJM199209103271104.

    PubMed 1298221

  • Mattson RH, Cramer JA, Collins JF. Prognosis for total control of complex partial and secondarily generalized tonic clonic seizures. Department of Veterans Affairs Epilepsy Cooperative Studies No. 118 and No. 264 Group. Neurology. 1996 Jul;47(1):68-76. doi: 10.1212/wnl.47.1.68.

    PubMed 8710127

  • Schmidt D. The clinical impact of new antiepileptic drugs after a decade of use in epilepsy. Epilepsy Res. 2002 Jun;50(1-2):21-32. doi: 10.1016/s0920-1211(02)00065-7.

    PubMed 12151114

  • Lhatoo SD, Wong IC, Polizzi G, Sander JW. Long-term retention rates of lamotrigine, gabapentin, and topiramate in chronic epilepsy. Epilepsia. 2000 Dec;41(12):1592-6. doi: 10.1111/j.1499-1654.2000.001592.x.

    PubMed 11114218

  • Morris GL 3rd, Mueller WM. Long-term treatment with vagus nerve stimulation in patients with refractory epilepsy. The Vagus Nerve Stimulation Study Group E01-E05. Neurology. 1999 Nov 10;53(8):1731-5. doi: 10.1212/wnl.53.8.1731.

    PubMed 10563620

  • Malow BA, Edwards J, Marzec M, Sagher O, Ross D, Fromes G. Vagus nerve stimulation reduces daytime sleepiness in epilepsy patients. Neurology. 2001 Sep 11;57(5):879-84. doi: 10.1212/wnl.57.5.879.

    PubMed 11552020

  • Harden CL, Pulver MC, Ravdin LD, Nikolov B, Halper JP, Labar DR. A Pilot Study of Mood in Epilepsy Patients Treated with Vagus Nerve Stimulation. Epilepsy Behav. 2000 Apr;1(2):93-99. doi: 10.1006/ebeh.2000.0046.

    PubMed 12609137

  • Elger G, Hoppe C, Falkai P, Rush AJ, Elger CE. Vagus nerve stimulation is associated with mood improvements in epilepsy patients. Epilepsy Res. 2000 Dec;42(2-3):203-10. doi: 10.1016/s0920-1211(00)00181-9.

    PubMed 11074193

  • Clark KB, Naritoku DK, Smith DC, Browning RA, Jensen RA. Enhanced recognition memory following vagus nerve stimulation in human subjects. Nat Neurosci. 1999 Jan;2(1):94-8. doi: 10.1038/4600.

    PubMed 10195186

  • McLachlan RS, Sadler M, Pillay N, Guberman A, Jones M, Wiebe S, Schneiderman J. Quality of life after vagus nerve stimulation for intractable epilepsy: is seizure control the only contributing factor? Eur Neurol. 2003;50(1):16-9. doi: 10.1159/000070853.

    PubMed 12824707

  • Cramer JA, Ben Menachem E, French J. Review of treatment options for refractory epilepsy: new medications and vagal nerve stimulation. Epilepsy Res. 2001 Nov;47(1-2):17-25. doi: 10.1016/s0920-1211(01)00286-8.

    PubMed 11673017

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vagal Nerve Simulation (VNS) Therapy and Best Medical Practive in people with Epilepsy and Partial Epilepsy, run by Cyberonics, Inc. at 48 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 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: stopped early, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Italy, France, Germany, Netherlands, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 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 17 May 2010). 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?

Overall Quality of Life in Epilepsy-89 (QOLIE-89) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment (time frame: Mean change from baseline QOLIE-89 Overall Score at 12 months). 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 NCT00522418, 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 Jan 2015.

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