SpasticityPhase 2/3NCT04099667
Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity
A Phase 2/3 study testing Phase 2; Low Dose MYOBLOC (15,000 Units), Phase 2; High Dose MYOBLOC (20,000 Units) and Phase 3; MYOBLOC in people with Spasticity, run by Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC at 9 sites in 3 countries.
Trial summary
Phase 2/3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial assessing the efficacy and safety of MYOBLOC for the treatment of lower limb spasticity, in adults followed by an open-label extension safety trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spasticity
- What is being tested?
- Phase 2; Low Dose MYOBLOC (15,000 Units), Phase 2; High Dose MYOBLOC (20,000 Units) and Phase 3; MYOBLOC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 17 Dec 2019to 24 Mar 2023
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand the potential risks and benefits, the study requirements, and provide written informed consent before enrollment into the study; or if unable, the subject's Legally Authorized Representative (LAR) may provide written informed consent.
- Male or female ≥18 to maximum of 80 years of age, inclusive.
- Lower limb spasticity due to stroke, traumatic brain injury, or spinal cord injury that occurred ≥6 months prior to randomization. Eligible subjects may have lower limb monoplegia or hemiplegia. Subjects with cerebral palsy are eligible for study enrollment.
- Ambulatory (with or without the use of a walking assistive device).
- Modified Ashworth Scale (MAS) score ≥2 in the ankle plantar flexors of the affected lower limb at screening and at baseline.
- In the Investigator's opinion, the subject will be available and able to comply with the study requirements for at least 1 year, based on the subject's overall health and disease prognosis.
- In the Investigator's opinion, the subject will be willing and able to comply with all requirements of the protocol, including completion of study questionnaires. A caregiver may be designated to assist with the physical completion of questionnaires/scales.
Who cannot join
- Quadriplegia/tetraplegia, lower limb diplegia or triplegia.
- Uncontrolled epilepsy or any type of seizure disorder with a seizure(s) within the previous year.
- Neuromuscular disorders including, but not limited to, amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), multiple sclerosis (MS), myasthenia gravis, or muscular dystrophy.
- History of major joint contracture(s), in which, based on the Investigator's assessment, the contracture(s) significantly contribute(s) to joint immobility in the affected lower limb.
- Unresolved fracture(s) in the affected lower limb.
- Severe atrophy in the affected lower limb.
Show all 41Show fewer
- Known hypersensitivity to botulinum toxins type A or B or to any MYOBLOC solution components.
- Concomitant use or exposure within 5 half-lives of randomization of the following: aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with neuromuscular function.
- Treatment with a neurolytic agent (e.g., phenol, alcohol blocks) to the affected lower limb within 1 year before randomization.
- Presence of a spinal stimulator or intrathecal baclofen pump that has not been turned off within 30 days before screening.
- Changes to treatment regimen or any new treatment with oral antispasmodics and/or muscle relaxants within 30 days before randomization.
- Initiation of physical and/or occupational therapy <30 days before randomization. Subjects receiving physical and/or occupational therapy ≥30 days before randomization must be willing to maintain their therapy regimen through Week 4 of the DBP.
- Application of an ankle-foot orthosis (AFO) <30 days before randomization. Subjects regularly using an AFO ≥30 days before randomization must be willing to maintain use of the AFO through Week 4 of the Double-Blind Period.
- Prior botulinum toxin type A (BoNT/A) or B (BoNT/B) treatment in the affected lower limb within 24 weeks before screening. Prior BoNT/A or BoNT/B treatment in areas other than the affected lower limb is not exclusionary but must have occurred at least 12 weeks before screening. Prior toxin exposure must have been well tolerated and without any significant long-term side effects in the case of repeated prior exposure.
- Subjects should not receive nor have any plans to receive any botulinum toxin treatment, other than the study drug (MYOBLOC), from the point informed consent is obtained until participation in the study is complete.
- Severe dysphagia (i.e., inability to swallow liquids, solids or both without choking or medical intervention), or dysphagia with a history of aspiration pneumonia, within 6 months before screening.
- Prior surgery to treat spasticity in the affected lower limb (i.e., tendon lengthening or tendon transfer).
- Any anticipated or scheduled surgery during the study period, with the exception of dermatological procedures performed under local anesthesia for the purposes of removing precancerous and cancerous lesions.
- Major surgery within 3 months before screening.
- Pregnancy or breastfeeding.
- Females of childbearing potential must agree to practice a medically acceptable method of contraception (e.g., intrauterine device, hormonal contraception started at least one full cycle before study enrollment or barrier method in conjunction with spermicide) for the duration of the study (including 2 months after study completion). For the purposes of this study, all females are considered to be of childbearing potential unless they are confirmed by the Investigator to be post-menopausal (at least 1 year since last menses and laboratory test confirmation), biologically sterile, or surgically sterile (e.g., hysterectomy with bilateral oophorectomy, tubal ligation).
- History of drug or alcohol abuse within 6 months before screening.
- Obstructive pulmonary disease with forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) <70%.
- Slow vital capacity (SVC) <60% of predicted.
- Chronic or current use of inhaled corticosteroids.
- Ventilator dependence (i.e., 24-hour ventilator dependence when intubated, or due to a failure to wean the subject from the ventilator while hospitalized in the intensive care unit or respiratory care center). Subjects who use oxygen on an as-needed basis or during sleeping hours only via a nasal cannula are eligible for the study.
- Infection at the planned sites of injection.
- Treatment with an investigational drug, device, or biological agent within 30 days before screening or while participating in this study.
- Malignancy diagnosed 3 months before screening.
- Has one or more screening clinical laboratory test values outside the reference range that, in the opinion of the Investigator, are clinically significant, or any of the following :
- Serum creatinine >1.5 times the upper limit of normal (ULN);
- Serum total bilirubin > 1.5 times ULN;
- Serum alanine aminotransferase or aspartate aminotransferase >2 times ULN.
- Has any of the following cardiology findings at screening:
- Abnormal ECG that is, in the Investigator's opinion/evaluation, clinically significant;
- PR interval >220 ms;
- QRS interval >130 ms;
- QTcF interval >450 ms (for men), or >470 ms (for women) (QT corrected using Fridericia's method);
- Second-or third-degree atrioventricular block;
- Any rhythm, other than sinus rhythm, that is interpreted or assessed by the Investigator to be clinically significant.
- Any other medical illness, condition, or clinical finding that, in the opinion of the Investigator and/or the Sponsor, would put the subject at undue risk.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States4 sites
Idaho Physical Medicine and Rehabilitation
Boise, Idaho, 83706
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Rancho Research Institute
Downey, California, 90242
Coastal Neurology
Port Royal, South Carolina, 29935
Poland4 sites
Specjalistyczna Praktyka Lekarska
Katowice, 40-097
Specjalistyczne Gabinety
Krakow, 30-539
Centrum Medyczne Linden
Krakow, 31-721
Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) Neuromed
Lubin, 20-604
About this study
Official title: A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity
Phase 2/3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial assessing the efficacy and safety of MYOBLOC for the treatment of lower limb spasticity, in adults followed by an open-label extension safety trial.
Read the detailed description
Phase 2, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial will compare the efficacy and safety of two doses of MYOBLOC (15,000 Units and 20,000 Units)versus volume-matched placebo in the treatment of lower limb spasticity in adults. An interim analysis will evaluate all available safety and efficacy data from the Phase 2 double-blind trial in order to recommend which dose will be evaluated in subsequent Phase 3 trial. The Phase 3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial will compare the efficacy and safety of MYOBLOC versus placebo in the treatment of lower limb spasticity in adults. Subjects who complete either the Phase 2 or Phase 3 trial will continue into an open-label extension part of the study where each will receive 4 separate treatments of MYOBLOC (20,000-25,000 Units) ~13 weeks apart for lower limb spasticity.
- Conditions
- Spasticity
- Being tested
- Phase 2; Low Dose MYOBLOC (15,000 Units), Phase 2; High Dose MYOBLOC (20,000 Units), Phase 2; Placebo, Phase 3; MYOBLOC, Phase 3; Placebo
- Keywords
- Stroke, Traumatic Brain Injury (TBI), Monoplegia, Hemiplegia, Lower limb
- Medical subject headings
- Muscle Spasticity, Stroke, Brain Injuries, Traumatic, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 2; Low Dose MYOBLOC (15,000 Units)Drug
Also called rimabotulinumtoxinB, botulinum toxin type B
Intramuscular injections on Day 1
Phase 2; High Dose MYOBLOC (20,000 Units)Drug
Also called rimabotulinumtoxinB, botulinum toxin type B
Intramuscular injections on Day 1
Phase 2; PlaceboDrug
Also called PBO
Intramuscular injections on Day 1
Phase 3; MYOBLOCDrug
Also called rimabotulinumtoxinB, botulinum toxin type B
Intramuscular injections on Day 1
Phase 3; PlaceboDrug
Also called PBO
Intramuscular injections on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Phase 2; Low Dose MYOBLOC (15,000 Units) | Experimental | Low Dose MYOBLOC (15,000 Units) is a single treatment and will be compared to volume-matched placebo Receives: Drug: Phase 2; Low Dose MYOBLOC (15,000 Units) |
| Phase 2; High Dose MYOBLOC (20,000 Units) | Experimental | High Dose MYOBLOC (20,000 Units) is a single treatment and will be compared to volume-matched placebo Receives: Drug: Phase 2; High Dose MYOBLOC (20,000 Units) |
| Phase 2; Placebo | Placebo comparator | Volume-matched placebo is a single treatment Receives: Drug: Phase 2; Placebo |
| Phase 3; MYOBLOC | Experimental | MYOBLOC is a single treatment and will be compared to volume-matched placebo Receives: Drug: Phase 3; MYOBLOC |
| Phase 3; Placebo | Placebo comparator | Volume-matched placebo is a single treatment Receives: Drug: Phase 3; Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change From Baseline in the Modified Ashworth Scale (MAS) Score in the Tone of the Ankle Plantar Flexors at Week 4 Post-injection.
The Modified Ashworth Scale (MAS) is an internationally accepted and validated instrument used to measure resistance during passive soft-tissue stretching. Resistance will be measured and recorded using a 6-point scale ranging from 0 (no increase in muscle tone) to 4 (affected part[s] rigid in flexion or extension). The post-injection MAS score is subtracted from the baseline MAS score to yield the change from baseline MAS score. A change from baseline MAS score <0 represents a better outcome.
Measured: Baseline and Week 4
The Clinical Global Impression of Change (CGI-C) Score in Functional Ability at Week 4 Post-injection
The Clinical Global Impression of Change (CGI-C) scale is a single item clinician assessment of how much the patient's functional ability has improved, worsened or has not changed relative to the patient's baseline state prior to treatment (injection). The CGI-C is rated on a 7-point Likert scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". A CGI-C score <4 represents a better outcome.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start17 Dec 2019
- Primary completion24 Mar 2023
- Study completion24 Mar 2023
Why it stopped: Company/sponsor business decision; not due to or related to any safety concerns
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 SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph T Hull, PhD, Study director, Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099667
- Sponsor's protocol ID
- SN-SPAS-202
- Status last verified
- Apr 2026
- First submitted
- 20 Sep 2019
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity
- ClinicalTrials.gov ID
- NCT04099667
- Acronym / sponsor ID
- SN-SPAS-202
- Conditions
- Spasticity
- Keywords
- Stroke, Traumatic Brain Injury (TBI), Monoplegia, Hemiplegia, Lower limb
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company/sponsor business decision; not due to or related to any safety concerns
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2/3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial assessing the efficacy and safety of MYOBLOC for the treatment of lower limb spasticity, in adults followed by an open-label extension safety trial.
Detailed description
Phase 2, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial will compare the efficacy and safety of two doses of MYOBLOC (15,000 Units and 20,000 Units)versus volume-matched placebo in the treatment of lower limb spasticity in adults. An interim analysis will evaluate all available safety and efficacy data from the Phase 2 double-blind trial in order to recommend which dose will be evaluated in subsequent Phase 3 trial. The Phase 3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial will compare the efficacy and safety of MYOBLOC versus placebo in the treatment of lower limb spasticity in adults. Subjects who complete either the Phase 2 or Phase 3 trial will continue into an open-label extension part of the study where each will receive 4 separate treatments of MYOBLOC (20,000-25,000 Units) ~13 weeks apart for lower limb spasticity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase 2; Low Dose MYOBLOC (15,000 Units) | Experimental | Drug: Phase 2; Low Dose MYOBLOC (15,000 Units)Low Dose MYOBLOC (15,000 Units) is a single treatment and will be compared to volume-matched placebo |
| Phase 2; High Dose MYOBLOC (20,000 Units) | Experimental | Drug: Phase 2; High Dose MYOBLOC (20,000 Units)High Dose MYOBLOC (20,000 Units) is a single treatment and will be compared to volume-matched placebo |
| Phase 2; Placebo | Placebo comparator | Drug: Phase 2; PlaceboVolume-matched placebo is a single treatment |
| Phase 3; MYOBLOC | Experimental | Drug: Phase 3; MYOBLOCMYOBLOC is a single treatment and will be compared to volume-matched placebo |
| Phase 3; Placebo | Placebo comparator | Drug: Phase 3; PlaceboVolume-matched placebo is a single treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to understand the potential risks and benefits, the study requirements, and provide written informed consent before enrollment into the study; or if unable, the subject's Legally Authorized Representative (LAR) may provide written informed consent.
- Male or female ≥18 to maximum of 80 years of age, inclusive.
- Lower limb spasticity due to stroke, traumatic brain injury, or spinal cord injury that occurred ≥6 months prior to randomization. Eligible subjects may have lower limb monoplegia or hemiplegia. Subjects with cerebral palsy are eligible for study enrollment.
- Ambulatory (with or without the use of a walking assistive device).
- Modified Ashworth Scale (MAS) score ≥2 in the ankle plantar flexors of the affected lower limb at screening and at baseline.
Key exclusion criteria (41 listed)
- Quadriplegia/tetraplegia, lower limb diplegia or triplegia.
- Uncontrolled epilepsy or any type of seizure disorder with a seizure(s) within the previous year.
- Neuromuscular disorders including, but not limited to, amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), multiple sclerosis (MS), myasthenia gravis, or muscular dystrophy.
- History of major joint contracture(s), in which, based on the Investigator's assessment, the contracture(s) significantly contribute(s) to joint immobility in the affected lower limb.
- Unresolved fracture(s) in the affected lower limb.
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 |
|---|---|---|
| Phase 2; Low Dose MYOBLOC (15,000 Units)Also: rimabotulinumtoxinB, botulinum toxin type BIntramuscular injections on Day 1 | Drug | Phase 2; Low Dose MYOBLOC (15,000 Units) |
| Phase 2; High Dose MYOBLOC (20,000 Units)Also: rimabotulinumtoxinB, botulinum toxin type BIntramuscular injections on Day 1 | Drug | Phase 2; High Dose MYOBLOC (20,000 Units) |
| Phase 2; PlaceboAlso: PBOIntramuscular injections on Day 1 | Drug | Phase 2; Placebo |
| Phase 3; MYOBLOCAlso: rimabotulinumtoxinB, botulinum toxin type BIntramuscular injections on Day 1 | Drug | Phase 3; MYOBLOC |
| Phase 3; PlaceboAlso: PBOIntramuscular injections on Day 1 | Drug | Phase 3; Placebo |
Primary outcome
The Change From Baseline in the Modified Ashworth Scale (MAS) Score in the Tone of the Ankle Plantar Flexors at Week 4 Post-injection.
Time frame: Baseline and Week 4
The Modified Ashworth Scale (MAS) is an internationally accepted and validated instrument used to measure resistance during passive soft-tissue stretching. Resistance will be measured and recorded using a 6-point scale ranging from 0 (no increase in muscle tone) to 4 (affected part[s] rigid in flexion or extension). The post-injection MAS score is subtracted from the baseline MAS score to yield the change from baseline MAS score. A change from baseline MAS score <0 represents a better outcome.
The Clinical Global Impression of Change (CGI-C) Score in Functional Ability at Week 4 Post-injection
Time frame: Week 4
The Clinical Global Impression of Change (CGI-C) scale is a single item clinician assessment of how much the patient's functional ability has improved, worsened or has not changed relative to the patient's baseline state prior to treatment (injection). The CGI-C is rated on a 7-point Likert scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". A CGI-C score <4 represents a better outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Joseph T Hull, PhD study director
Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Phase 2; Low Dose MYOBLOC (15,000 Units), Phase 2; High Dose MYOBLOC (20,000 Units) and Phase 3; MYOBLOC in people with Spasticity, run by Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC at 9 sites in 3 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 7 inclusion and 41 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Poland, Hungary. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 22 May 2026). 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?
The Change From Baseline in the Modified Ashworth Scale (MAS) Score in the Tone of the Ankle Plantar Flexors at Week 4 Post-injection. (time frame: Baseline and Week 4). The study lists 2 primary outcomes in all. 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 22 May 2026.