Parkinson DiseasePhase 4FARM9X59Y4NCT02741947
Levodopa Benserazide Generic Formulation Versus the Originator
A Phase 4 study testing Levodopa Benserazide Madopar and Levodopa Benserazide Teva Italia in people with Parkinson Disease, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial summary
The trial was an experimental two-centers, randomized, double-blind, two-sequence, non-inferiority cross-over study. Screened subjects already treated with Levodopa/Benserazide (LDB) (Madopar®) who agreed to participate in the study entered a 4 weeks period if not on stable regimen of Madopar® (run-in period). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Levodopa Benserazide Madopar and Levodopa Benserazide Teva Italia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2014to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Out-patients with a diagnosis of idiopathic Parkinson's disease for at least 5 years, receiving L-dopa/benserazide, were enrolled to participate into the study. The patients were recruited within the patient population using the hospitals out-patients clinics.
- Subject must be ≥30 and ≤75 years of age, of either sex and of any race.
- Diagnosis of Parkinson's disease
- Subjects in Hoehn and Yahr stages 2 to 4.
- Subject must have good response to levodopa (≥30% improvement in the UPDRS score).
- Subject must have been on a stable regimen of L-dopa for at least 4 month before Screening.
- A female subject must be postmenopausal, or sterile or use a medically accepted method of contraception.
- Fragile population was included in the trial (Elderly 65-74 years and over 75 years).
Who cannot join
- Atypical Parkinsonism
- Subjects with very severe motor fluctuations and/or dyskinesias.
- Significant internal-medicine or psychiatric diseases.
- Subject's clinical laboratory tests outside the normal ranges.
- History of previous rhabdomyolysis
- Subjects in therapy with Catechol-O-methyltransferase-inhibitor.
Show all 9Show fewer
- Subjects who participated in any other clinical trial in the 4 months before the screening.
- Any subject who is pregnant or breastfeeding.
- Subjects demented or not able to give informed consent to trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Pharmacokinetics Study to Evaluate the Therapeutic Equivalence and Bioequivalence of Levodopa Benserazide Generic Formulation (Teva Italia) Versus the Originator (Madopar®)
The trial was an experimental two-centers, randomized, double-blind, two-sequence, non-inferiority cross-over study.
Screened subjects already treated with Levodopa/Benserazide (LDB) (Madopar®) who agreed to participate in the study entered a 4 weeks period if not on stable regimen of Madopar® (run-in period). Following the run-in period, there were two maintenance periods of 4 weeks each, for a total duration of 8 weeks.
Read more
Patients were assigned randomly (1:1) by a computerized randomization system to one of two formulation sequences maintaining the dose stabilized during the run in:
- generic-originator
- originator-generic At the end of maintenance period 1, the patients in each formulation group underwent an overnight switch to the same dose of the alternative formulation. The dose was kept stable during the whole length of trial. Clinical evaluations were performed at the end of each period. The tablets were encapsulated to maintain the blindness.
A pharmacokinetic study with a fixed dose (100+25 mg) was performed in a sub-population of 14 subjects.
Population: out-patients with a diagnosis of idiopathic Parkinson's disease for at least 5 years, receiving L-dopa/benserazide.
The total duration of the trial was approximately 8 weeks for patient divided in two maintenance periods of 4 weeks each.
Read the detailed description
The trial was an experimental two-centers, randomized, double-blind, two-sequence, non-inferiority cross-over study.
Population: out-patients with a diagnosis of idiopathic Parkinson's disease (PD) for at least 5 years, receiving Levodopa, were enrolled to participate into the study. The study was performed in hospital setting using the facilities of the clinical trial centre in both sites involved in the study. The patients were recruited within the patient population using the hospitals out-patients clinics. Recruitment timing lasted 18 months.
Screened subjects who agreed to participate in the study, taking Levodopa/Benserazide LDB (Madopar®) entered a 4 weeks period with stable regimen of Madopar® (run-in period). The formulations of levodopa admitted in the trial were: Madopar® 100+25; and 200+50 (1/2 or 1 tablet). Following the run-in period, there were two key phases of the study: two maintenance periods (4 weeks each), for a total duration of 8 weeks. Patients were assigned randomly (1:1) by a computerized randomization system to one of two formulation sequences maintaining the dose stabilized during the run in:
- generic-originator
- originator-generic At the end of maintenance period 1, the patients in each formulation group underwent an overnight switching to the same dose of the alternative formulation. The dose was kept stable during the whole length of trial. Clinical evaluations were performed at the end of each period (see flow chart enclosed). The tablets were encapsulated to maintain the blindness. A pharmacokinetic study with a fixed dose (100+25 mg) was performed in a sub-population of 14 subjects. The drugs was administered orally. In case of prolonged, not tolerable akinetic periods during the study, the patients could be rescued with an extra dose of levodopa. Any antiparkinsonian treatment modification or supplementation of antiparkinsonian drugs was not allowed during the study. Any other drug not specific for Parkinson's disease was evaluated by the investigators and allowed only if necessary and if not interfering with the study drugs.
The random allocation of patients to one of the two treatment groups was centrally managed by the coordinating centre, according to an automatically generated randomization list provided by the team responsible for the data collection monitoring and statistical analysis. An allocation ratio of 1:1 was assumed when generating the list. Patients eligible to enter the randomization procedure was sequentially assigned to the lowest randomization sequence number not yet assigned to any study subject. For each randomization number, a sealed envelope containing the randomization code was prepared by the team that generated the randomization list. Unblinding was permitted only if strictly necessary. In case it was essential to know the treatment assigned to a patient due to serious unexpected adverse events, the envelope containing the patient's randomization code could be open. In such cases, a detailed report on the timing, the causes and the patient's randomization number would have been issued by the person responsible for the trial and archived by the coordinating centre.
Mechanical blinding (encapsulation) was used to ensure the double-blind nature of the study. Because the patients enrolled in the trial received levodopa/benserazide in different doses, over-encapsulation of tablets permitted blinding of most oral dosage forms: ½ tablet, several small tablets, capsules of different sizes or colors. Each capsule was then be placed in a narrow opaque tube and identified as "Treatment 1" and "Treatment 2" before administration to the patient. The patient, the investigator, Medical Monitor and Clinical Monitor remained blinded, whereas the site pharmacist and a nurse who administered study medication were not blind throughout this part of the study.
No interim analysis was planned for this protocol. Amendments: no amendments were presented during the study.
- Conditions
- Parkinson Disease
- Being tested
- Levodopa Benserazide Madopar, Levodopa Benserazide Teva Italia
- Keywords
- Parkinson, Therapeutic Equivalence, Levodopa
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levodopa Benserazide MadoparDrug
Madopar 100+25mg and 200+50mg, tablet, tid e qid, for four weeks
Levodopa Benserazide Teva ItaliaDrug
Levodopa benserazide Teva 100+25mg and 200+50mg, tablet, tid e qid, for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Levodopa Benserazide Madopar | Active comparator | Madopar 100+25mg and 200+50mg, tablet, tid e qid, for four weeks Receives: Drug: Levodopa Benserazide Madopar |
| Levodopa Benserazide Teva Italia | Experimental | Levodopa Benserazide Teva Italia100+25mg and 200+50mg, tablet, tid e qid, for four weeks Receives: Drug: Levodopa Benserazide Teva Italia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bioequivalence in the total Area Under the Curve (AUC-t) between the generic levodopa/benserazide and the originator.
AUC-t: area under the curve within first and last observed point
Measured: end of maintenance period 1 and maintenance period 2 (each period of 4 weeks)
Change in therapeutic equivalence measured with the Unified Parkinson's Disease rating scale part III between the generic levodopa/benserazide and the originator.
A difference of -3 points on the UPDRS motor score be the margin for non-inferiority
Measured: end of maintenance period 1 and maintenance period 2 (each period of 4 weeks)
Secondary outcomes (4)
Change in Patient Clinical Global Impression - Global Improvement scale between the generic levodopa/benserazide and the originator.
Measured: end of maintenance period 1 and maintenance period 2 (each period of 4 weeks)
Change in bioequivalence in minimum concentration (Cmin) between the generic levodopa/benserazide and the originator.
Measured: end of maintenance period 1 and maintenance period 2 (each period of 4 weeks)
Change in bioequivalence in time to maximum concentration (Tmax) after the last dose between the generic levodopa/benserazide and the originator.
Measured: end of maintenance period 1 and maintenance period 2 (each period of 4 weeks)
Change in bioequivalence in the half life (t 1/2) after the last dose between the generic levodopa/benserazide and the originator.
Measured: end of maintenance period 1 and maintenance period 2 (each period of 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startApr 2014
- Primary completionDec 2015
- Study completionDec 2015
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 Parkinson DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Collaborators
- Agenzia Italiana del Farmaco
- Responsible party
- Sponsor
- Investigators
- FABRIZIO STOCCHI, PROFESSOR, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741947
- Sponsor's protocol ID
- RP 13/12
- Acronym
- FARM9X59Y4
- Status last verified
- Apr 2016
- First submitted
- 31 Mar 2016
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Stocchi F, Jenner P, Obeso JA. When do levodopa motor fluctuations first appear in Parkinson's disease? Eur Neurol. 2010;63(5):257-66. doi: 10.1159/000300647. Epub 2010 Mar 24.
PubMed 20332641Olanow CW, Agid Y, Mizuno Y, Albanese A, Bonuccelli U, Damier P, De Yebenes J, Gershanik O, Guttman M, Grandas F, Hallett M, Hornykiewicz O, Jenner P, Katzenschlager R, Langston WJ, LeWitt P, Melamed E, Mena MA, Michel PP, Mytilineou C, Obeso JA, Poewe W, Quinn N, Raisman-Vozari R, Rajput AH, Rascol O, Sampaio C, Stocchi F. Levodopa in the treatment of Parkinson's disease: current controversies. Mov Disord. 2004 Sep;19(9):997-1005. doi: 10.1002/mds.20243.
PubMed 15372588Stocchi F. The levodopa wearing-off phenomenon in Parkinson's disease: pharmacokinetic considerations. Expert Opin Pharmacother. 2006 Jul;7(10):1399-407. doi: 10.1517/14656566.7.10.1399.
PubMed 16805724
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Pharmacokinetics Study to Evaluate the Therapeutic Equivalence and Bioequivalence of Levodopa Benserazide Generic Formulation (Teva Italia) Versus the Originator (Madopar®)
- ClinicalTrials.gov ID
- NCT02741947
- Acronym / sponsor ID
- FARM9X59Y4 / RP 13/12
- Conditions
- Parkinson Disease
- Keywords
- Parkinson, Therapeutic Equivalence, Levodopa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Collaborators
- Agenzia Italiana del Farmaco
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Apr 2016 (estimated)
- 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.
The trial was an experimental two-centers, randomized, double-blind, two-sequence, non-inferiority cross-over study.
Screened subjects already treated with Levodopa/Benserazide (LDB) (Madopar®) who agreed to participate in the study entered a 4 weeks period if not on stable regimen of Madopar® (run-in period). Following the run-in period, there were two maintenance periods of 4 weeks each, for a total duration of 8 weeks.
Patients were assigned randomly (1:1) by a computerized randomization system to one of two formulation sequences maintaining the dose stabilized during the run in:
- generic-originator
- originator-generic At the end of maintenance period 1, the patients in each formulation group underwent an overnight switch to the same dose of the alternative formulation. The dose was kept stable during the whole length of trial. Clinical evaluations were performed at the end of each period. The tablets were encapsulated to maintain the blindness.
A pharmacokinetic study with a fixed dose (100+25 mg) was performed in a sub-population of 14 subjects.
Population: out-patients with a diagnosis of idiopathic Parkinson's disease for at least 5 years, receiving L-dopa/benserazide.
The total duration of the trial was approximately 8 weeks for patient divided in two maintenance periods of 4 weeks each.
Detailed description
The trial was an experimental two-centers, randomized, double-blind, two-sequence, non-inferiority cross-over study.
Population: out-patients with a diagnosis of idiopathic Parkinson's disease (PD) for at least 5 years, receiving Levodopa, were enrolled to participate into the study. The study was performed in hospital setting using the facilities of the clinical trial centre in both sites involved in the study. The patients were recruited within the patient population using the hospitals out-patients clinics. Recruitment timing lasted 18 months.
Screened subjects who agreed to participate in the study, taking Levodopa/Benserazide LDB (Madopar®) entered a 4 weeks period with stable regimen of Madopar® (run-in period). The formulations of levodopa admitted in the trial were: Madopar® 100+25; and 200+50 (1/2 or 1 tablet). Following the run-in period, there were two key phases of the study: two maintenance periods (4 weeks each), for a total duration of 8 weeks. Patients were assigned randomly (1:1) by a computerized randomization system to one of two formulation sequences maintaining the dose stabilized during the run in:
- generic-originator
- originator-generic At the end of maintenance period 1, the patients in each formulation group underwent an overnight switching to the same dose of the alternative formulation. The dose was kept stable during the whole length of trial. Clinical evaluations were performed at the end of each period (see flow chart enclosed). The tablets were encapsulated to maintain the blindness. A pharmacokinetic study with a fixed dose (100+25 mg) was performed in a sub-population of 14 subjects. The drugs was administered orally. In case of prolonged, not tolerable akinetic periods during the study, the patients could be rescued with an extra dose of levodopa. Any antiparkinsonian treatment modification or supplementation of antiparkinsonian drugs was not allowed during the study. Any other drug not specific for Parkinson's disease was evaluated by the investigators and allowed only if necessary and if not interfering with the study drugs.
The random allocation of patients to one of the two treatment groups was centrally managed by the coordinating centre, according to an automatically generated randomization list provided by the team responsible for the data collection monitoring and statistical analysis. An allocation ratio of 1:1 was assumed when generating the list. Patients eligible to enter the randomization procedure was sequentially assigned to the lowest randomization sequence number not yet assigned to any study subject. For each randomization number, a sealed envelope containing the randomization code was prepared by the team that generated the randomization list. Unblinding was permitted only if strictly necessary. In case it was essential to know the treatment assigned to a patient due to serious unexpected adverse events, the envelope containing the patient's randomization code could be open. In such cases, a detailed report on the timing, the causes and the patient's randomization number would have been issued by the person responsible for the trial and archived by the coordinating centre.
Mechanical blinding (encapsulation) was used to ensure the double-blind nature of the study. Because the patients enrolled in the trial received levodopa/benserazide in different doses, over-encapsulation of tablets permitted blinding of most oral dosage forms: ½ tablet, several small tablets, capsules of different sizes or colors. Each capsule was then be placed in a narrow opaque tube and identified as "Treatment 1" and "Treatment 2" before administration to the patient. The patient, the investigator, Medical Monitor and Clinical Monitor remained blinded, whereas the site pharmacist and a nurse who administered study medication were not blind throughout this part of the study.
No interim analysis was planned for this protocol. Amendments: no amendments were presented during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levodopa Benserazide Madopar | Active comparator | Drug: Levodopa Benserazide MadoparMadopar 100+25mg and 200+50mg, tablet, tid e qid, for four weeks |
| Levodopa Benserazide Teva Italia | Experimental | Drug: Levodopa Benserazide Teva ItaliaLevodopa Benserazide Teva Italia100+25mg and 200+50mg, tablet, tid e qid, for four weeks |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Out-patients with a diagnosis of idiopathic Parkinson's disease for at least 5 years, receiving L-dopa/benserazide, were enrolled to participate into the study. The patients were recruited within the patient population using the hospitals out-patients clinics.
- Subject must be ≥30 and ≤75 years of age, of either sex and of any race.
- Diagnosis of Parkinson's disease
- Subjects in Hoehn and Yahr stages 2 to 4.
- Subject must have good response to levodopa (≥30% improvement in the UPDRS score).
Key exclusion criteria (9 listed)
- Atypical Parkinsonism
- Subjects with very severe motor fluctuations and/or dyskinesias.
- Significant internal-medicine or psychiatric diseases.
- Subject's clinical laboratory tests outside the normal ranges.
- History of previous rhabdomyolysis
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 |
|---|---|---|
| Levodopa Benserazide MadoparMadopar 100+25mg and 200+50mg, tablet, tid e qid, for four weeks | Drug | Levodopa Benserazide Madopar |
| Levodopa Benserazide Teva ItaliaLevodopa benserazide Teva 100+25mg and 200+50mg, tablet, tid e qid, for four weeks | Drug | Levodopa Benserazide Teva Italia |
Primary outcome
Change in bioequivalence in the total Area Under the Curve (AUC-t) between the generic levodopa/benserazide and the originator.
Time frame: end of maintenance period 1 and maintenance period 2 (each period of 4 weeks)
AUC-t: area under the curve within first and last observed point
Change in therapeutic equivalence measured with the Unified Parkinson's Disease rating scale part III between the generic levodopa/benserazide and the originator.
Time frame: end of maintenance period 1 and maintenance period 2 (each period of 4 weeks)
A difference of -3 points on the UPDRS motor score be the margin for non-inferiority
4 secondary outcomes
Change in Patient Clinical Global Impression - Global Improvement scale between the generic levodopa/benserazide and the originator.
Time frame: end of maintenance period 1 and maintenance period 2 (each period of 4 weeks)
Change in bioequivalence in minimum concentration (Cmin) between the generic levodopa/benserazide and the originator.
Time frame: end of maintenance period 1 and maintenance period 2 (each period of 4 weeks)
Change in bioequivalence in time to maximum concentration (Tmax) after the last dose between the generic levodopa/benserazide and the originator.
Time frame: end of maintenance period 1 and maintenance period 2 (each period of 4 weeks)
Change in bioequivalence in the half life (t 1/2) after the last dose between the generic levodopa/benserazide and the originator.
Time frame: end of maintenance period 1 and maintenance period 2 (each period of 4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Results publication: PubMed 20332641Stocchi F, Jenner P, Obeso JA. When do levodopa motor fluctuations first appear in Parkinson's disease? Eur Neurol. 2010;63(5):257-66. doi: 10.1159/000300647. Epub 2010 Mar 24.
- Results publication: PubMed 15372588Olanow CW, Agid Y, Mizuno Y, Albanese A, Bonuccelli U, Damier P, De Yebenes J, Gershanik O, Guttman M, Grandas F, Hallett M, Hornykiewicz O, Jenner P, Katzenschlager R, Langston WJ, LeWitt P, Melamed E, Mena MA, Michel PP, Mytilineou C, Obeso JA, Poewe W, Quinn N, Raisman-Vozari R, Rajput AH, Rascol O, Sampaio C, Stocchi F. Levodopa in the treatment of Parkinson's disease: current controversies. Mov Disord. 2004 Sep;19(9):997-1005. doi: 10.1002/mds.20243.
- Results publication: PubMed 16805724Stocchi F. The levodopa wearing-off phenomenon in Parkinson's disease: pharmacokinetic considerations. Expert Opin Pharmacother. 2006 Jul;7(10):1399-407. doi: 10.1517/14656566.7.10.1399.
- 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.
FABRIZIO STOCCHI, PROFESSOR principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levodopa Benserazide Madopar and Levodopa Benserazide Teva Italia in people with Parkinson Disease, run by IRCCS San Raffaele Roma at 1 site in Italy.
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 8 inclusion and 9 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 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in bioequivalence in the total Area Under the Curve (AUC-t) between the generic levodopa/benserazide and the originator. (time frame: end of maintenance period 1 and maintenance period 2 (each period of 4 weeks)). 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?
On the ClinicalTrials.gov record for NCT02741947, 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 10 Apr 2024.