Myotonic Dystrophy 1NCT03981575
Estab Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1)
An observational study of Myotonic Dystrophy 1 and DM1, run by Virginia Commonwealth University at 17 sites in 7 countries.
Trial summary
Building on previous work of the Myotonic Dystrophy Clinical Research Network (DMCRN), the present study seeks to overcome insufficient data on natural history; lack of reliable biomarkers; and incomplete characterization and limited biological understanding of the phenotypic heterogeneity of Myotonic Dystrophy 1 by… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myotonic Dystrophy 1, DM1
- How many people
- 700 participants
- Where
- 17 sitesin 7 countries
- Study dates
- 1 Jan 2019to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: DM1 has a prevalence rate of approximately 1 per 2,300. There are no expected gender differences. Both men and women will be selected for this study. Children with DM1 are not included in this project because the pathophysiological basis of congenital and childhood DM1 appears to be mechanistically distinct.
Who may be able to join
- Age 18 to 70 (inclusive)
- Competent to provide informed consent
- Clinical diagnosis of DM1 based on research criteria1 or positive genetic test
- Comment: The clinical research criteria require myotonia, muscle weakness in a characteristic distribution, and history of similar findings in a first degree relative. Genetic testing confirmed the diagnosis of DM1 in > 99% of individuals who satisfied these criteria.2
Who cannot join
- Symptomatic renal or liver disease, uncontrolled diabetes or thyroid disorder, or active malignancy other than skin cancer.
- Current alcohol or substance abuse
- Concurrent enrollment in clinical trial for DM1, or participation in trial within 6 months of entry.
- Concurrent pregnancy or planned pregnancy during the course of the study.
- Concurrent medical condition that would, in the opinion of the investigator or clinical evaluator, compromise performance on study measures.
- Note: non-ambulatory participants are not excluded, but are limited to <15% of enrollment.
Show all 16Show fewer
- Inclusion criteria for participants in the muscle biopsy sub-study:
- Of the 95 patients undergoing the tibialis anterior muscle biopsy, at least half will have at least moderate weakness of ankle dorsiflexion, defined as MRC score ≤ 4+. This is in order to obtain a muscle tissue sample in a person more severely affected with myotonic dystrophy. Approximately 10 patients at each site will undergo the muscle biopsy.
- Exclusion criteria for 95 participants in the muscle biopsy sub-study:
- Known CTG repeat expansion size less than 100 repeats, unless there are clear cut signs of limb weakness and muscle wasting. This is in order to obtain a muscle tissue sample in a person more severely affected with myotonic dystrophy.
- Use of anticoagulant such as warfarin or a direct oral anticoagulant (e.g. dabigatran) due to the increased risk of bleeding.
- Use of aspirin or non-steroidal anti-inflammatory agents should be discontinued 3 days prior to the biopsy procedure, if possible.
- Platelet count <50,000 (if known) due to the increased risk of bleeding.
- History of a bleeding disorder due to the increased risk of bleeding.
- Advanced wasting of tibialis anterior (TA) muscle that precludes needle muscle biopsy in order to ensure that a sample taken would be of muscle and not just fat and fascia.
- Previous muscle biopsy of either TA in order to provide muscle tissue samples of non-biopsied muscles.
Trial locations and contacts
17 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 7 countries
United States10 sites, 10 recruiting
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Kaneshia Hives, 614-685-5661, Kaneshia.Hives@osumc.edu
Lischele Watkins, lischele.watkins@osumc.edu
- Recruiting
University of Colorado - Denver
Denver, Colorado, 80204
Alyssa Avilez, 303-724-4644, alyssa.avilez@cuanschutz.edu
Brianna Blume, 303-724-6386, brianna.blume@cuanschutz.edu
- Recruiting
University of Florida
Gainesville, Florida, 32611
Whitney Miller, whitney.miller@neurology.ufl.edu
Donovan Lott, djlottpt@phhp.ufl.edu
- Recruiting
Houston Methodist Neurological Institute
Houston, Texas, 77030
Kadeesia Brown, 346-238-2295, kbrown5@houstonmethodist.org
Erika P. Greene
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Maegan Tyrrell, 319-356-8323, maegan-tyrrell@uiowa.edu
Loraine Brenner, loraine-brenner@uiowa.edu
- Recruiting
Kansas University Medical Center
Kansas City, Kansas, 66160
Rebecca Clay, rclay@kumc.edu
Michaela Walker, mwalker20@kumc.edu
- Recruiting
University of California, San Diego
La Jolla, California, 92703
Elizabeth Moreno, e4moreno@health.ucsd.edu
Gabriella Penner, gpenner@health.ucsd.edu
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Dennis Fernando, 310-825-3264, DeFernando@mednet.ucla.edu
Perry Shieh, MD, PhD
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Carino Jennings, Carino.Garza@vcuhealth.org
Jodie Howell, jodie.howell@vcuhealth.org
- Recruiting
University of Rochester
Rochester, New York, 14642
Jim Hilbert, 585-273-5590, james_hilbert@urmc.rochester.edu
Jeanne Dekdebrun, 585-276-4611, Jeanne_dekdebrun@urmc.rochester.edu
United Kingdom2 sites, 2 recruiting
- Recruiting
St. George's, University of London
London
Emma Matthews, 020 8725 4162, ematthew@sgul.ac.uk
Emma Matthews
- Recruiting
University College London
London
Chris Turner, chris.turner7@nhs.net
Iqraa Afzal, iqraa.afzal@nhs.net
Germany1 site, 1 recruiting
- Recruiting
Friedrich Baur Institute, Ludwig-Maximilians-Universität München
München
Benedikt Schoser, +49 (0)89 4400 57400, benedikt.schoser@med.lmu.ede
Corinna Wirner-Piotrowski, +49 89 4400 57400, Corinna.Wirner@med.uni-muenchen.de
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Medical Center
Nijmegen
Baziel vanEngelen, (024) 366 8374, Baziel.vanEngelen@radboudumc.nl
Monique Plieger, Monique.Plieger@radboudumc.nl
New Zealand1 site, 1 recruiting
- Recruiting
University of Auckland
Auckland
Neerja Singh, neerja.singh@auckland.ac.nz
Miriam Rodrigues, 021896662, mrodrigues@adhb.govt.nz
About this study
Official title: Establishing Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1)
Building on previous work of the Myotonic Dystrophy Clinical Research Network (DMCRN), the present study seeks to overcome insufficient data on natural history; lack of reliable biomarkers; and incomplete characterization and limited biological understanding of the phenotypic heterogeneity of Myotonic Dystrophy 1 by examining strategies to improve the reliability by making further refinements in our sample collection and analysis procedures by developing strategies for managing patient heterogeneity going forward.
Funding Source- FDA OOPD
Read the detailed description
Approximately 700 adult participants (18 to 70 years old, inclusive) with DM1 will be enrolled at 15 centers (up to 70 patients will be recruited at each site). No treatment will be administered as part of this study. Participants will receive standard of care as determined by the investigators. Study visits occur at baseline/0 months, 12 months, and 24 months. Few restrictions are placed on participation in the study because the investigators aim to capture the full spectrum of disease severity.
Muscle biopsy sub-study: Studies of splicing biomarkers in muscle biopsy samples will be conducted on a subset of 95 participants. These participants will have an additional study visit at 3 months.
Longitudinal muscle biopsy sub-study: Up to 30 individuals who have had a prior muscle biopsy as part of a DMCRN study will be asked to undergo another biopsy greater than 24 months after the prior biopsy. These participants will have an additional ad hoc biopsy visit.
COVID-19 sub-study: To evaluate severity of illness and response to COVID-19 vaccination in DM1 patients compared to corresponding data available about the general population, END-DM1 study participants will be asked to complete a one-time survey about COVID-19 experiences. A subset of those participants' blood samples will be analyzed to understand immunoglobulin response to infection and vaccination in DM1 patients.
Actigraphy sub-study: To assess daily physical activity in individuals with DM1 and evaluate physical activity changes over a 12-24 month period related to disease progression, a subset of participants will be asked to wear a small, wireless activity monitor while performing functional assessments described in the main study. Those participants will be asked to wear the activity monitor for 7 days following their research visit. Those participants will be asked to complete additional questionnaires.
Handheld Dynamometry sub-study: To evaluate additional muscle strength methods, a subset of participants will be asked to complete additional strength testing using either the MEDup or MicroFET handheld dynamometry device on the same day as their END-DM1 main study visit. Those participants will be asked to return to the clinic for a second visit within 10 days of the END-DM1 study visit to repeat the handheld dynamometry assessments and complete additional strength measures.
- Conditions
- Myotonic Dystrophy 1, DM1
- Keywords
- Myotonic Dystrophy, END DM-1, Muscular Dystophy, DMCRN
- Medical subject headings
- Myotonic Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Visits | Patients will receive standard of care as determined by their treating physician. Study visits occur at baseline/0 months, 12 months, and 24 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ambulation over 24 months as measured by the 10 meter walk (m/s).
10 meter walk will be measured (m/s)
Measured: 12 and 24 months
Change in respiratory function over 24 months as measured by spirometry, specifically the supine forced vital capacity (FVC).
Supine forced vital capacity (% predicted)
Measured: 12 and 24 months
Percent splicing of DM1-affected splice events
RNA sequenced of muscle biopsy samples collected at two different times will be combined and used to calculate a percent splicing index (PMI)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start1 Jan 2019
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myotonic Dystrophy 1Studies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rochester, Stanford University, Ohio State University, University of Florida, University of Iowa, Ludwig-Maximilians - University of Munich, Fondazione Serena Onlus - Centro Clinico NeMO Milano, The Methodist Hospital Research Institute, Radboud University Medical Center, University College London Hospitals, University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Nicholas Johnson, MD, Principal investigator, Virginia Commonwealth UniversityCharles Thornton, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981575
- Sponsor's protocol ID
- HM20014419
- Other IDs
- DMCRN, FD-R-006071
- Status last verified
- Nov 2026
- First submitted
- 2 Jun 2019
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregated and deidentified data will be shared with qualified investigators upon majority approval of the DMCRN investigators.
Publications
Leeuwenberg KE, Sansone VA, Hamel J, Hung M, Dekdebrun JM, Lizio A, Eichinger K, Gagnon C, Roxburgh RH, Subramony SH, Statland JM, Elsheikh BH, Turner C, Matthews EL, Ragole TE, Sampson JB, Schoser B, Takahashi MP, Wicklund MP, Swenson AJ, Laverty CG, Shieh PB, Greene EP, Raymond J, DeSpain E, Thornton CA, Mul K, Johnson NE; Myotonic Dystrophy Clinical Research Network. Prospective Study of Video Hand Opening Time as a Quantitative Measurement of Myotonia in Patients With Myotonic Dystrophy Type 1. Neurology. 2026 Apr 14;106(7):e214747. doi: 10.1212/WNL.0000000000214747. Epub 2026 Feb 26.
PubMed 41747205Mul K, Eichinger K, Hung M, Sansone VA, Gagnon C, Subramony S, Roxburgh RH, Hamel J, Statland JM, Elsheikh B, Turner C, Sampson J, Ragole T, Matthews E, Schoser B, Swenson A, Laverty C, Shieh P, Greene EP, Takahashi M, Wicklund M, Dekdebrun J, Raymond J, DeSpain E, Thornton CA, Johnson NE; Myotonic Dystrophy Clinical Research Network. Establishing biomarkers and clinical endpoints in myotonic dystrophy type 1 (END-DM1): Protocol of an international natural history study. PLoS One. 2025 Dec 11;20(12):e0331163. doi: 10.1371/journal.pone.0331163. eCollection 2025.
PubMed 41379803Provenzano M, Ikegami K, Bates K, Gaynor A, Hartman JM, Jones A, Butler A, Berggren KN, Dekdebrun J, Hung M, Lapato DM, Kiefer M, Thornton CA, Johnson NE, Hale MA; Myotonic Dystrophy Clinical Research Network (DMCRN). The Splice Index as a prognostic biomarker of strength and function in myotonic dystrophy type 1. J Clin Invest. 2025 Jan 7;135(4):e185426. doi: 10.1172/JCI185426.
PubMed 39836447
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1)
- ClinicalTrials.gov ID
- NCT03981575
- Acronym / sponsor ID
- HM20014419
- Conditions
- Myotonic Dystrophy 1, DM1
- Keywords
- Myotonic Dystrophy, END DM-1, Muscular Dystophy, DMCRN
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- University of Rochester, Stanford University, Ohio State University, University of Florida, University of Iowa, Ludwig-Maximilians - University of Munich, Fondazione Serena Onlus - Centro Clinico NeMO Milano, The Methodist Hospital Research Institute, Radboud University Medical Center, University College London Hospitals, University of California, Los Angeles
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 11 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Building on previous work of the Myotonic Dystrophy Clinical Research Network (DMCRN), the present study seeks to overcome insufficient data on natural history; lack of reliable biomarkers; and incomplete characterization and limited biological understanding of the phenotypic heterogeneity of Myotonic Dystrophy 1 by examining strategies to improve the reliability by making further refinements in our sample collection and analysis procedures by developing strategies for managing patient heterogeneity going forward.
Funding Source- FDA OOPD
Detailed description
Approximately 700 adult participants (18 to 70 years old, inclusive) with DM1 will be enrolled at 15 centers (up to 70 patients will be recruited at each site). No treatment will be administered as part of this study. Participants will receive standard of care as determined by the investigators. Study visits occur at baseline/0 months, 12 months, and 24 months. Few restrictions are placed on participation in the study because the investigators aim to capture the full spectrum of disease severity.
Muscle biopsy sub-study: Studies of splicing biomarkers in muscle biopsy samples will be conducted on a subset of 95 participants. These participants will have an additional study visit at 3 months.
Longitudinal muscle biopsy sub-study: Up to 30 individuals who have had a prior muscle biopsy as part of a DMCRN study will be asked to undergo another biopsy greater than 24 months after the prior biopsy. These participants will have an additional ad hoc biopsy visit.
COVID-19 sub-study: To evaluate severity of illness and response to COVID-19 vaccination in DM1 patients compared to corresponding data available about the general population, END-DM1 study participants will be asked to complete a one-time survey about COVID-19 experiences. A subset of those participants' blood samples will be analyzed to understand immunoglobulin response to infection and vaccination in DM1 patients.
Actigraphy sub-study: To assess daily physical activity in individuals with DM1 and evaluate physical activity changes over a 12-24 month period related to disease progression, a subset of participants will be asked to wear a small, wireless activity monitor while performing functional assessments described in the main study. Those participants will be asked to wear the activity monitor for 7 days following their research visit. Those participants will be asked to complete additional questionnaires.
Handheld Dynamometry sub-study: To evaluate additional muscle strength methods, a subset of participants will be asked to complete additional strength testing using either the MEDup or MicroFET handheld dynamometry device on the same day as their END-DM1 main study visit. Those participants will be asked to return to the clinic for a second visit within 10 days of the END-DM1 study visit to repeat the handheld dynamometry assessments and complete additional strength measures.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Visits | – | –Patients will receive standard of care as determined by their treating physician. Study visits occur at baseline/0 months, 12 months, and 24 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- DM1 has a prevalence rate of approximately 1 per 2,300. There are no expected gender differences. Both men and women will be selected for this study. Children with DM1 are not included in this project because the pathophysiological basis of congenital and childhood DM1 appears to be mechanistically distinct.
Key inclusion criteria (4 listed)
- Age 18 to 70 (inclusive)
- Competent to provide informed consent
- Clinical diagnosis of DM1 based on research criteria1 or positive genetic test
- Comment: The clinical research criteria require myotonia, muscle weakness in a characteristic distribution, and history of similar findings in a first degree relative. Genetic testing confirmed the diagnosis of DM1 in > 99% of individuals who satisfied these criteria.2
Key exclusion criteria (16 listed)
- Symptomatic renal or liver disease, uncontrolled diabetes or thyroid disorder, or active malignancy other than skin cancer.
- Current alcohol or substance abuse
- Concurrent enrollment in clinical trial for DM1, or participation in trial within 6 months of entry.
- Concurrent pregnancy or planned pregnancy during the course of the study.
- Concurrent medical condition that would, in the opinion of the investigator or clinical evaluator, compromise performance on study measures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in ambulation over 24 months as measured by the 10 meter walk (m/s).
Time frame: 12 and 24 months
10 meter walk will be measured (m/s)
Change in respiratory function over 24 months as measured by spirometry, specifically the supine forced vital capacity (FVC).
Time frame: 12 and 24 months
Supine forced vital capacity (% predicted)
Percent splicing of DM1-affected splice events
Time frame: 3 months
RNA sequenced of muscle biopsy samples collected at two different times will be combined and used to calculate a percent splicing index (PMI)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Derived from this study: PubMed 41747205Leeuwenberg KE, Sansone VA, Hamel J, Hung M, Dekdebrun JM, Lizio A, Eichinger K, Gagnon C, Roxburgh RH, Subramony SH, Statland JM, Elsheikh BH, Turner C, Matthews EL, Ragole TE, Sampson JB, Schoser B, Takahashi MP, Wicklund MP, Swenson AJ, Laverty CG, Shieh PB, Greene EP, Raymond J, DeSpain E, Thornton CA, Mul K, Johnson NE; Myotonic Dystrophy Clinical Research Network. Prospective Study of Video Hand Opening Time as a Quantitative Measurement of Myotonia in Patients With Myotonic Dystrophy Type 1. Neurology. 2026 Apr 14;106(7):e214747. doi: 10.1212/WNL.0000000000214747. Epub 2026 Feb 26.
- Derived from this study: PubMed 41379803Mul K, Eichinger K, Hung M, Sansone VA, Gagnon C, Subramony S, Roxburgh RH, Hamel J, Statland JM, Elsheikh B, Turner C, Sampson J, Ragole T, Matthews E, Schoser B, Swenson A, Laverty C, Shieh P, Greene EP, Takahashi M, Wicklund M, Dekdebrun J, Raymond J, DeSpain E, Thornton CA, Johnson NE; Myotonic Dystrophy Clinical Research Network. Establishing biomarkers and clinical endpoints in myotonic dystrophy type 1 (END-DM1): Protocol of an international natural history study. PLoS One. 2025 Dec 11;20(12):e0331163. doi: 10.1371/journal.pone.0331163. eCollection 2025.
- Derived from this study: PubMed 39836447Provenzano M, Ikegami K, Bates K, Gaynor A, Hartman JM, Jones A, Butler A, Berggren KN, Dekdebrun J, Hung M, Lapato DM, Kiefer M, Thornton CA, Johnson NE, Hale MA; Myotonic Dystrophy Clinical Research Network (DMCRN). The Splice Index as a prognostic biomarker of strength and function in myotonic dystrophy type 1. J Clin Invest. 2025 Jan 7;135(4):e185426. doi: 10.1172/JCI185426.
- Individual participant dataSharing planned: No. Aggregated and deidentified data will be shared with qualified investigators upon majority approval of the DMCRN investigators.
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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.
Nicholas Johnson, MD principal investigator
Virginia Commonwealth University
Charles Thornton, MD principal investigator
University of Rochester
17 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myotonic Dystrophy 1 and DM1, run by Virginia Commonwealth University at 17 sites in 7 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 4 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, United Kingdom, Canada, Germany, Italy and 2 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Raymond (804-828-6318, jennifer.raymond@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ambulation over 24 months as measured by the 10 meter walk (m/s). (time frame: 12 and 24 months). 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 NCT03981575, which also lists 3 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 3 Nov 2026.