NeoplasmsMARVEL-PICNCT05667766
Minimising Adverse Drug Reactions and Verifying Economic Legitimacy in Children (MARVEL-PIC)
A study testing Release of Extended Pharmacogenomics Report at Week 1 and Release of Extended Pharmacogenomics Report at Week 13 in people with Neoplasms and Bone Marrow Transplantation, run by Murdoch Childrens Research Institute at 4 sites in Australia.
Trial summary
A prospective, open, randomised implementation study in paediatric cancer patients. The study aims to determine whether a personalised approach will result in an overall reduction in clinically relevant adverse drug reactions (ADRs) and to evaluate the economic and quality of life impacts. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Neoplasms, Bone Marrow Transplantation
- What is being tested?
- Release of Extended Pharmacogenomics Report at Week 1 and Release of Extended Pharmacogenomics Report at Week 13
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 441 participants
- Where
- 4 sitesAustralia
- Study dates
- 22 Mar 2023to Aug 2027
- Phase
- Interventional
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age < 18 years
- New cancer diagnosis or patient receiving HSCT or patient has a relapsed cancer diagnosis and is starting treatment after more than 6 months without.
- Starting treatment with a chemotherapeutic agent that is not single agent oral targeted therapy.
- Must also be taking a medication for which there is an established CPIC guideline available.
- Parent or patient is able and willing to give consent for patient to take part and be followed up for at least 12 weeks.
- Patient is amenable to venepuncture and blood draw (5mL ideally with an absolute minimum requirement of 2.5 mL) or has Whole Genome Sequencing available (WGS).
Show all 9Show fewer
- Patient and/or parent is able and willing to sign an informed consent form.
- Patient and/or parent is able to complete Ped-PRO-CTCAE survey in English, Italian or Chinese.
- Study enrolment limit has not been reached.
Who cannot join
- Age > 18 years.
- Patient has a life expectancy estimated to be less than three months by the treating clinical team.
- Duration of the drug of inclusion total treatment length is planned to be less than one week.
- Patient and/or parent is unable to consent to the study.
- Patient and/or parent is unwilling to take part in the study.
- Patient and/or parent is able unable to complete Ped-PRO-CTCAE survey in English, Italian or Chinese.
Show all 9Show fewer
- Patient has existing impaired hepatic or renal function for which a lower dose or alternate drug selection are already part of current routine care.
- Patient has a glomerular filtration rate of less than 15 mL/min per 1.73m2.
- Patient has advanced liver failure.
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Perth Children's Hospital
Nedlands, Washington, 6009
Women's and Children's Hospital
North Adelaide, South Australia, 5006
The Royal Children's Hospital
Parkville, Victoria, 3052
Sydney Children's Hospital
Randwick, New South Wales, 2031
About this study
Official title: Minimising Adverse Drug Reactions and Verifying Economic Legitimacy - Pharmacogenomics Implementation in Children (MARVEL-PIC)
A prospective, open, randomised implementation study in paediatric cancer patients. The study aims to determine whether a personalised approach will result in an overall reduction in clinically relevant adverse drug reactions (ADRs) and to evaluate the economic and quality of life impacts. Participants will be randomised to receive personalised guided prescribing of supportive care therapy (study arm) or standard of care (control arm) for a period of 12 weeks. The follow up period includes prospective patient reporting of symptoms and quality of life through electronically delivered surveys, for a maximum of 12 months.
Read the detailed description
One of the main areas of precision medicine that is easily implementable is pharmacogenomic testing. Germline testing of genes predisposing to drug toxicity or inefficacy can inform drug selection and dosing. This steers away from the historical 'trial and error' approach, avoids unnecessary adverse drug reactions (ADRs) and can potentially impact on health economic savings, through reduction in readmissions and admissions with ADRs.
This study will be a prospective, open, randomised implementation study in paediatric and adolescent patients with a new diagnosis of cancer or who are proceeding to first haematopoietic stem cell transplantation (HSCT). The current standard of care for paediatrics in Australia involves pharmacogenomic testing for TPMT and NUD15, for patients with acute lymphoblastic leukaemia. Participants of the study will receive pharmacogenomic testing across a range of clinically relevant variants. Participants will be randomised to either the control arm or the study arm. Test results for participants in the study arm will be used to guide the dose and drug selection of 27 drugs commonly used in supportive care. The pharmacogenomic test results will be released to the study arm at week 4 and to the control arm at week 13, after the 12 week intervention period.
To determine whether pre-emptive pharmacogenomic testing does reduce clinically relevant adverse drug reactions, the Paediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE) survey will be delivered at 3 time points within a 12 week period. This survey is a patient reported outcome measurement tool developed to evaluate symptomatic toxicity in participants receiving cancer therapy. After survey completion, semi-structured interviews will be conducted by an academic pharmacist with the aim of generating a CTCAE grade of severity for each of the symptoms defined in the Ped-PRO-CTCAE and assessing the causality of an adverse drug reaction using the Liverpool Adverse Drug Reaction Causality Assessment Tool (Liverpool ADR-CAT). These mechanisms will support the assessment of both severity and causality of any adverse drug reactions.
To evaluate the economic and Quality of Life impacts (QoL), participants will also complete The Child Health Utility 9D (CHU9D) QoL surveys specific to children and young adults at 3 timepoints over the 12-month period and consent to a Health Economics Analysis. This includes collection of Medicare Benefits Schedule (MBS)/ Pharmaceutical Benefits Scheme (PBS) data from Services Australia and Victorian Data Linkage Group to compare the costs of management of both the control and study arm.
Data from the study will be securely stored on the REDCap database. Patients will be allocated a unique patient identifier prior to their de-identified data being added to the database.
- Conditions
- Neoplasms, Bone Marrow Transplantation
- Being tested
- Release of Extended Pharmacogenomics Report at Week 1, Release of Extended Pharmacogenomics Report at Week 13
- Keywords
- cancer, paediatric, pharmacogenomic
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Release of Extended Pharmacogenomics Report at Week 1Diagnostic test
Whole genome sequencing with reporting on current standard of care (SoC) pharmacogenomic variants (TPMT, NUD15) where applicable (i.e, for patients with diagnosis of acute lymphoblastic leukaemia) by Week 1. Whole genome sequencing on a broader number of actionable variants as per international guidelines for cancer supportive care (identical to study arm) will be reported on at Week 13.
Release of Extended Pharmacogenomics Report at Week 13Diagnostic test
Whole genome sequencing with reporting on current standard of care (SoC) pharmacogenomic variants (TPMT, NUD15) where applicable (i.e, for patients with diagnosis of acute lymphoblastic leukaemia) and reporting of a broader number of actionable pharmacogenomic variants as per international guidelines for cancer supportive care reported on by Week 1.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | Standard of Care prescribing for period of 12 months. Participants will receive pharmacogenomic test results according to the current standard of care. The participants will be followed up for a minimum of 12 weeks, with maximal time-period being 12 months depending on time of enrolment. Receives: Diagnostic Test: Release of Extended Pharmacogenomics Report at Week 13 |
| Experimental Arm | Experimental | Extended Pharmacogenomic prescribing for a period of 12 months. Participants will receive pharmacogenomic testing across a range of clinically relevant variants, to guide the dose and drug selection of 27 drugs commonly used in supportive care. The participants will be followed up for a minimum of 12 weeks, with maximal time-period being 12 months depending on time of enrolment. Receives: Diagnostic Test: Release of Extended Pharmacogenomics Report at Week 1; Diagnostic Test: Release of Extended Pharmacogenomics Report at Week 13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the number of adverse drug reactions (ADRs)
The primary outcome is a reduction in adverse drug reactions among patients with actionable pharmacogenomic variants. An adverse drug reaction will be considered as any CTCAE grade 2 and above for non-haematological toxicities or CTCAE grade 3 and above for haematological toxicities. CTCAE grades are defined as 1,2,3,4 or 5, with 5 indicating the most severe.
Measured: 12 weeks
Secondary outcomes (11)
Occurrence of at least one ADR which contributes to primary endpoint
An adverse drug reaction will be considered as any CTCAE grade 2 and above for non-haematological toxicities or CTCAE grade 3 and above for haematological toxicities. This includes an ADR which was caused either by the index drug of inclusion or any subsequent drug. CTCAE grades are defined as 1,2,3,4 or 5, with 5 indicated the most severe.
Measured: 12 weeks
Occurrence of at least one causal, clinically relevant, drug-genotype specific ADR, attributable to the index drug.
The Liverpool ADR CAT is an assessment tool produced to attribute causality to specific drugs for the grading of ADR symptomatic toxicity. Possible grading of ADRs include either definite, probable or possible.
Measured: 12 weeks
Number of self-reported ADRs
The Ped-PRO-CTCAE survey is an electronic patient reported outcome measurement survey developed to evaluate symptomatic toxicity in patients who are receiving cancer therapy. Symptoms are evaluated for attributes of frequency, severity, interference, amount, presence or absence. Each symptomatic adverse event (AE) is assessed by 1-3 attributes that can be linked back to a CTCAE grade. The number of self-reported ADRs are measured independent of severity or drug-gene association but caused by one of the chemotherapeutic /targeted agents.
Measured: 12 weeks
Number of serious self-reported ADRs
The Ped-PRO-CTCAE survey is an electronic patient reported outcome measurement survey developed to evaluate symptomatic toxicity in patients who are receiving cancer therapy. Symptoms are evaluated for attributes of frequency, severity, interference, amount, presence or absence. Each symptomatic adverse event (AE) is assessed by 1-3 attributes that can be linked back to a CTCAE grade. The number of self-reported ADRs are measured independent of severity or drug-gene association but caused by one of the chemotherapeutic /targeted agents. An ADR will be classified as serious if that event led to death, serious deterioration in health, or fetal distress.
Measured: 12 weeks
Number of dose adjustments
Number of dose adjustments made to drug-gene associated therapy during the entire study follow up by review of the participants electronic medical record and medication reconciliation.
Measured: 12 weeks
Incidence of drug cessation due to ADR
Incidence of drug cessation due to ADR during the entire study follow up. Relates to inclusion criteria drug by review of the participants electronic medical record and medication reconciliation.
Measured: 12 months
Incidence of drug cessation due to lack of efficacy
Incidence of drug cessation due to lack of efficacy by review of the participants electronic medical record and medication reconciliation.
Measured: 12 months
Therapeutic drug monitoring
Therapeutic drug monitoring (routine drug levels) performed during entire study follow up period by review of the participants electronic medical record and medication reconciliation.
Measured: 12 months
Physician and Pharmacist adherence to the CPIC guidelines
After discussion and consensus of a pharmacogenetic variant. A clinical report will be generated with the results and therapeutic recommendations according to Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines. Adherence to recommendations will be reported with reasoning, during the 12 week period.
Measured: 12 months
Health care expenditure related to adverse events using MBS/PBS data
Data will be collected on the costs of management comparing the standard of care arm versus the study arm. The actual costs assigned to each inpatient or outpatient episode will be collected. This information is readily accessible through Services Australia and The Department of Health via The Centre for Victorian Data Linkage (CVDL).
Measured: 12 months
Change in quality of life outcomes using CHU9D
The University of Sheffield CHU9D Quality of Life Survey will be used to monitor changes in patient QoL. The CHU9D consists of a descriptive system and set of preference weights, for 9 questions that assess participants daily functioning across the following domains: worry, sadness, pain, tiredness, annoyance, school, sleep, daily routine and activities. The tool allows for calculation of quality adjusted life years for use in cost utility analysis
Measured: Baseline, Week 12, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start22 Mar 2023
- Primary completion30 Jun 2026
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A/Prof Rachel Conyers, Principal investigator, The Royal Children's Hospital/Murdoch Children's Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667766
- Sponsor's protocol ID
- 89083
- Acronym
- MARVEL-PIC
- Status last verified
- Jul 2026
- First submitted
- 19 Dec 2022
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified data set collected for this analysis of the study will be available from 6 months after publication of the primary outcome. Only de-identified data will published. The study protocol, analysis plan and consent forms will also be available. The data may be obtained from the Murdoch Children's Research Institute by emailing MCTC@mcri.edu.au.
Publications
Conyers R, Halman A, Moore C, Stenta T, Felmingham B, Collier L, Khatri D, Spelman T, Williams E, Dyas R, Kotecha RS, Jessop S, Mateos MK, Swen J, Elliott DA. Minimising Adverse Drug Reactions and Verifying Economic Legitimacy-Pharmacogenomics Implementation in Children (MARVEL- PIC): protocol for a national randomised controlled trial of pharmacogenomics implementation. BMJ Open. 2024 May 16;14(5):e085115. doi: 10.1136/bmjopen-2024-085115.
PubMed 38760050
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimising Adverse Drug Reactions and Verifying Economic Legitimacy - Pharmacogenomics Implementation in Children (MARVEL-PIC)
- ClinicalTrials.gov ID
- NCT05667766
- Acronym / sponsor ID
- MARVEL-PIC / 89083
- Conditions
- Neoplasms, Bone Marrow Transplantation
- Keywords
- cancer, paediatric, pharmacogenomic
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 29 Dec 2022 (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.
A prospective, open, randomised implementation study in paediatric cancer patients. The study aims to determine whether a personalised approach will result in an overall reduction in clinically relevant adverse drug reactions (ADRs) and to evaluate the economic and quality of life impacts. Participants will be randomised to receive personalised guided prescribing of supportive care therapy (study arm) or standard of care (control arm) for a period of 12 weeks. The follow up period includes prospective patient reporting of symptoms and quality of life through electronically delivered surveys, for a maximum of 12 months.
Detailed description
One of the main areas of precision medicine that is easily implementable is pharmacogenomic testing. Germline testing of genes predisposing to drug toxicity or inefficacy can inform drug selection and dosing. This steers away from the historical 'trial and error' approach, avoids unnecessary adverse drug reactions (ADRs) and can potentially impact on health economic savings, through reduction in readmissions and admissions with ADRs.
This study will be a prospective, open, randomised implementation study in paediatric and adolescent patients with a new diagnosis of cancer or who are proceeding to first haematopoietic stem cell transplantation (HSCT). The current standard of care for paediatrics in Australia involves pharmacogenomic testing for TPMT and NUD15, for patients with acute lymphoblastic leukaemia. Participants of the study will receive pharmacogenomic testing across a range of clinically relevant variants. Participants will be randomised to either the control arm or the study arm. Test results for participants in the study arm will be used to guide the dose and drug selection of 27 drugs commonly used in supportive care. The pharmacogenomic test results will be released to the study arm at week 4 and to the control arm at week 13, after the 12 week intervention period.
To determine whether pre-emptive pharmacogenomic testing does reduce clinically relevant adverse drug reactions, the Paediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE) survey will be delivered at 3 time points within a 12 week period. This survey is a patient reported outcome measurement tool developed to evaluate symptomatic toxicity in participants receiving cancer therapy. After survey completion, semi-structured interviews will be conducted by an academic pharmacist with the aim of generating a CTCAE grade of severity for each of the symptoms defined in the Ped-PRO-CTCAE and assessing the causality of an adverse drug reaction using the Liverpool Adverse Drug Reaction Causality Assessment Tool (Liverpool ADR-CAT). These mechanisms will support the assessment of both severity and causality of any adverse drug reactions.
To evaluate the economic and Quality of Life impacts (QoL), participants will also complete The Child Health Utility 9D (CHU9D) QoL surveys specific to children and young adults at 3 timepoints over the 12-month period and consent to a Health Economics Analysis. This includes collection of Medicare Benefits Schedule (MBS)/ Pharmaceutical Benefits Scheme (PBS) data from Services Australia and Victorian Data Linkage Group to compare the costs of management of both the control and study arm.
Data from the study will be securely stored on the REDCap database. Patients will be allocated a unique patient identifier prior to their de-identified data being added to the database.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Diagnostic Test: Release of Extended Pharmacogenomics Report at Week 13Standard of Care prescribing for period of 12 months. Participants will receive pharmacogenomic test results according to the current standard of care. The participants will be followed up for a minimum of 12 weeks, with maximal time-period being 12 months depending on time of enrolment. |
| Experimental Arm | Experimental | Diagnostic Test: Release of Extended Pharmacogenomics Report at Week 1, Diagnostic Test: Release of Extended Pharmacogenomics Report at Week 13Extended Pharmacogenomic prescribing for a period of 12 months. Participants will receive pharmacogenomic testing across a range of clinically relevant variants, to guide the dose and drug selection of 27 drugs commonly used in supportive care. The participants will be followed up for a minimum of 12 weeks, with maximal time-period being 12 months depending on time of enrolment. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age < 18 years
- New cancer diagnosis or patient receiving HSCT or patient has a relapsed cancer diagnosis and is starting treatment after more than 6 months without.
- Starting treatment with a chemotherapeutic agent that is not single agent oral targeted therapy.
- Must also be taking a medication for which there is an established CPIC guideline available.
- Parent or patient is able and willing to give consent for patient to take part and be followed up for at least 12 weeks.
Key exclusion criteria (9 listed)
- Age > 18 years.
- Patient has a life expectancy estimated to be less than three months by the treating clinical team.
- Duration of the drug of inclusion total treatment length is planned to be less than one week.
- Patient and/or parent is unable to consent to the study.
- Patient and/or parent is unwilling to take part in the study.
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 |
|---|---|---|
| Release of Extended Pharmacogenomics Report at Week 1Whole genome sequencing with reporting on current standard of care (SoC) pharmacogenomic variants (TPMT, NUD15) where applicable (i.e, for patients with diagnosis of acute lymphoblastic leukaemia) by Week 1. Whole genome sequencing on a broader number of actionable variants as per international guidelines for cancer supportive care (identical to study arm) will be reported on at Week 13. | Diagnostic test | Experimental Arm |
| Release of Extended Pharmacogenomics Report at Week 13Whole genome sequencing with reporting on current standard of care (SoC) pharmacogenomic variants (TPMT, NUD15) where applicable (i.e, for patients with diagnosis of acute lymphoblastic leukaemia) and reporting of a broader number of actionable pharmacogenomic variants as per international guidelines for cancer supportive care reported on by Week 1. | Diagnostic test | Experimental Arm, Standard of Care |
Primary outcome
Reduction in the number of adverse drug reactions (ADRs)
Time frame: 12 weeks
The primary outcome is a reduction in adverse drug reactions among patients with actionable pharmacogenomic variants. An adverse drug reaction will be considered as any CTCAE grade 2 and above for non-haematological toxicities or CTCAE grade 3 and above for haematological toxicities. CTCAE grades are defined as 1,2,3,4 or 5, with 5 indicating the most severe.
11 secondary outcomes
Occurrence of at least one ADR which contributes to primary endpoint
Time frame: 12 weeks
Occurrence of at least one causal, clinically relevant, drug-genotype specific ADR, attributable to the index drug.
Time frame: 12 weeks
Number of self-reported ADRs
Time frame: 12 weeks
Number of serious self-reported ADRs
Time frame: 12 weeks
Number of dose adjustments
Time frame: 12 weeks
Incidence of drug cessation due to ADR
Time frame: 12 months
Incidence of drug cessation due to lack of efficacy
Time frame: 12 months
Therapeutic drug monitoring
Time frame: 12 months
Physician and Pharmacist adherence to the CPIC guidelines
Time frame: 12 months
Health care expenditure related to adverse events using MBS/PBS data
Time frame: 12 months
Change in quality of life outcomes using CHU9D
Time frame: Baseline, Week 12, 12 months
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 29 Jul 2026.
- Derived from this study: PubMed 38760050Conyers R, Halman A, Moore C, Stenta T, Felmingham B, Collier L, Khatri D, Spelman T, Williams E, Dyas R, Kotecha RS, Jessop S, Mateos MK, Swen J, Elliott DA. Minimising Adverse Drug Reactions and Verifying Economic Legitimacy-Pharmacogenomics Implementation in Children (MARVEL- PIC): protocol for a national randomised controlled trial of pharmacogenomics implementation. BMJ Open. 2024 May 16;14(5):e085115. doi: 10.1136/bmjopen-2024-085115.
- Individual participant dataSharing planned: Yes. The de-identified data set collected for this analysis of the study will be available from 6 months after publication of the primary outcome. Only de-identified data will published. The study protocol, analysis plan and consent forms will also be available. The data may be obtained from the Murdoch Children's Research Institute by emailing MCTC@mcri.edu.au.
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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.
A/Prof Rachel Conyers principal investigator
The Royal Children's Hospital/Murdoch Children's Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Release of Extended Pharmacogenomics Report at Week 1 and Release of Extended Pharmacogenomics Report at Week 13 in people with Neoplasms and Bone Marrow Transplantation, run by Murdoch Childrens Research Institute at 4 sites in Australia.
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 9 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: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. 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?
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?
Reduction in the number of adverse drug reactions (ADRs) (time frame: 12 weeks). 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 NCT05667766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.