MalariaMossie-GONCT06232954
Evaluation of the Protective Efficacy of a Spatial Repellent to Reduce Malaria Prevalence in Uganda
A study testing Mossie-Go containing treated transfluthrin disc and Mossie-Go containing untreated blank disc in people with Malaria and Mosquito-Borne Disease, run by Africa Power Limited at 1 site in Uganda.
Trial summary
A cluster-randomized double-blinded control trial will be conducted in Uganda to demonstrate and quantify the protective efficacy (PE) of Mossie-GO, an active spatial repellent system disseminating transfluthrin, in reducing the prevalence of malaria in children ≤ 5 years of age, as determined by RDT positivity and… Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Mosquito-Borne Disease
- What is being tested?
- Mossie-Go containing treated transfluthrin disc and Mossie-Go containing untreated blank disc
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,600 participants
- Where
- 1 siteUganda
- Study dates
- 5 Jun 2024to Sep 2025
- Phase
- Interventional
- 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 Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Cluster level:
- Number of households > 100
- Household level:
- Presence of a child ≤ 5 years of age at point of enrolment in the study
- Adult head of household agrees to receiving and using the device as per manual instructions
- Adult head of household agrees to data collection visits and household surveys
Show all 13Show fewer
- Children within household sleeps in cluster > 90% of nights during any given month
- Individual level:
- ≤ 5 years of age when enrolled into the study
- No plans for extended travel (> 1 month) outside of home during study
- Not participating in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
- Provision of informed consent form (ICF) by the parent(s) or guardian
- Participants not on regular malaria prophylaxis
Who cannot join
- Cluster level:
- Number of households < 100
- Household level:
- Presence of a child > 5 years of age at point of enrolment in the study
- Adult head of household does not agree to data collection visits and household surveys
- Children within household sleeps in cluster < 90% of nights during any given month
Show all 13Show fewer
- Households where study personnel identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile).
- Individual level:
- >5 years of age when enrolled into the study
- Plans for extended travel (> 1 month) outside of home during study
- Participating or planned participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
- No provision of ICF signed by the parent(s) or guardian
- Participants on regular malaria prophylaxis
Trial locations and contacts
1 site in 1 country.
Jane Achan, PhD contact
Uganda1 site, 1 recruiting
- Recruiting
Malaria Consortium
Jinja
Jane Achan, PhD, j.achan@malariaconsortium.org
About this study
Official title: Evaluation of the Protective Efficacy of a Spatial Repellent to Reduce Malaria Prevalence in Children ≤ 5 Years of Age in Uganda: Study Protocol for a Cluster-randomized Double-blinded Control Trial: The Mossie-GO Trial
A cluster-randomized double-blinded control trial will be conducted in Uganda to demonstrate and quantify the protective efficacy (PE) of Mossie-GO, an active spatial repellent system disseminating transfluthrin, in reducing the prevalence of malaria in children ≤ 5 years of age, as determined by RDT positivity and confirmed by microscopy. The study's secondary objective is to measure the diversionary impact of the intervention on locally unprotected individuals and impact of the intervention on entomological correlates of transmission including vector densities, host seeking behaviour and insecticide resistance. This will be conducted using Centre of Disease Control (CDC) light traps in households, human landing catches and World Health Organisation (WHO) tube tests. Further data collection include household behavioural surveys, air sampling to quantify concentration of transfluthrin present in air, acceptability surveys and intervention safety monitoring.
Recruited households will be monitored across baseline data collection and followed up for 2 disease transmission seasons, for up to 18 months. The devices will be distributed to all consented eligible households in the two study arms: intervention and control. Intervention arm devices will be provided with transfluthrin treated discs and refill transfluthrin discs at frequent enough intervals to provide sustained protection. Households in the control arm will receive blank discs with no active ingredient. Households will be asked to continue using other malaria prevention practices, such as the use of bed nets, as recommended by national policy.
Read the detailed description
The impact of Mossie-GO on malaria cases will be determined through a blinded cluster randomized trial in malaria endemic settings. The device will be distributed to all consented eligible households in the two study arms: intervention and control. Intervention arm devices will be provided with transfluthrin treated discs and refill transfluthrin discs at frequent enough intervals to provide sustained protection. Households in the control arm will receive blank discs with no active ingredient and refill blank discs to maintain study blinding.
The Mossie-GO repellent device is approximately 8 cm3 and can be fitted with repellent discs impregnated with transfluthrin and a carrier oil. These discs sit above a fan that is powered by a small motor charged by solar energy. The device is expected to both prevent bites and cause some mortality to mosquitoes when switched on for 8-12 hours overnight for up to 1 calendar month. The discs then need to be replaced. One Mossie-GO device will be provided per household, along with a solar cell unit that will be connected to the Mossie-GO unit and must be placed in direct sunlight to charge the Mossie-Go unit during the day, for use in the evening. Households will be asked to continue using other malaria prevention practices, such as bed nets, as recommended by national policy.
At baseline, Mossie-GO will be distributed at the household level and should be placed in the room of the participant enrolled into the study (child ≤ 5 years of age) while they are sleeping. At the same time a baseline survey will be conducted and children ≤ 5 years of age will be tested for malaria using RDTs and microscopy, to determine baseline malaria prevalence. At this time, household surveys will also be conducted to classify housing structure and collect other variables which may impact the efficacy of the intervention. Following this period, sample size estimates may be adjusted based on malaria prevalence. All recruited households will be monitored at 6-monthly intervals and malaria testing will be done among children ≤ 5 years of age with RDTs and microscopy over a period of up to 18 months. Indoor light traps will be installed in selected households for approximately 3-4 nights in the 6 month intervals and run from 6pm to 7 am to collect mosquitoes indoors, and human landing catches will be conducted. Air sampling will also be conducted alongside mosquito collections to quantify the concentrations of transfluthrin in the air and to help inform entomological and epidemiological outcomes. An acceptability survey will also be conducted at the final data collection time point
The unit of randomization is a cluster, which is defined as a discrete village or area containing a minimum of 100 households. Clusters will be divided into core and buffer zones. Twenty eight clusters will be identified per study arm (treatment and control), thus fifty six clusters will be selected in total. Households within the core zone of clusters will receive the Mossie-GO device (intervention or control). Households within the buffer zones will not receive the Mossie-GO. While all households within the core zone of the cluster are receiving the device, they will not all be sampled for the evaluation of the primary objective (PE). Only a total of 100 eligible, consenting households will be sampled within the core zones. Household surveys will also be conducted in these 100 households. For the evaluation of the secondary outcomes, a subset of houses will be selected. Diversionary impact: 100 households in buffer zone; entomological sampling: 10% of households in core zone; air sampling 1 household every 500m in core zone.
The primary outcome (PE) will be compared between arms using logistic regression with a random effect for study cluster and adverse event data will be collected and summarised.
- Conditions
- Malaria, Mosquito-Borne Disease
- Being tested
- Mossie-Go containing treated transfluthrin disc, Mossie-Go containing untreated blank disc
- Keywords
- malaria, spatial repellent, vector control, transfluthrin, randomised control trial
- Medical subject headings
- Malaria, Mosquito-Borne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mossie-Go containing treated transfluthrin discDevice
The Mossie-GO repellent device is approximately 8 cm3 and can be fitted with repellent discs impregnated with transfluthrin and a carrier oil. These discs sit above a fan that is powered by a small motor charged by solar energy. The device is expected to both prevent bites and cause some mortality to mosquitoes when switched on for 8-12 hours overnight for up to 1 calendar month. The discs then need to be replaced.
Mossie-Go containing untreated blank discDevice
The Mossie-GO repellent device is approximately 8 cm3 and can be fitted with a blank untreated disc. These discs sit above a fan that is powered by a small motor charged by solar energy. The device containing the untreated disc is not expected to prevent mosquito bites. The discs will still be replaced monthly for blinding purposes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All recruited households within the intervention arm will receive the Mossie-Go device containing transfluthrin treated discs and will be provided with refill transfluthrin discs at monthly intervals to provide sustained protection. Receives: Device: Mossie-Go containing treated transfluthrin disc |
| Control | Placebo comparator | All recruited households within the control arm will receive the Mossie-Go device containing untreated blank discs and will be provided with refill untreated blank discs at monthly intervals. Receives: Device: Mossie-Go containing untreated blank disc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malaria prevalence
Malaria prevalence among children ≤ 5 years of age as determined by Rapid Diagnostic Test (RDT) positivity and confirmed by microscopy.
Measured: 18 months
Secondary outcomes (6)
Assessment of the diversionary effect of spatial repellent in the buffer zone using RDT and microscopy
Clusters are defined as discrete villages with a core and buffer zone. Buffer zones will be approximately 2km from the outer perimeter of the core zone and will not receive the intervention. This buffer zone will mitigate against the diversionary impact in the instance where villages are split into multiple clusters. The diversionary impact of the intervention on mosquitoes to locally unprotected individuals will be evaluated by measuring the malaria prevalence among children ≤ 5 years of age as determined by Rapid Diagnostic Test (RDT) positivity and confirmed by microscopy in a subset of households in the buffer zones. Mosquito population density and human biting rate will also be measured in the buffer zones.
Measured: 18 months
Entomological correlates of transmission
Mosquito species composition and population density in mosquitoes caught using indoor CDC-light traps and Anopheline-human contact (indoor and outdoor) using human biting rate (HBR) as an indicator for all anophelines. Measured by human-landing catch (HLC).
Measured: 18 months
Household surveys
Household surveys to collect information on subject behaviour related to exposure to malaria and use of existing control tools
Measured: 18 months
Air sampling
Quantification of the temporal changes in concentration of transfluthrin present in the air over the duration of its use and the impact of indoor temperature on the concentration
Measured: 18 months
Safety of intervention
Safety of intervention through monitoring of adverse events (AEs) and serious adverse events (SAEs)
Measured: 18 months
Acceptability survey
Acceptability of Mossie-GO in these communities
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start5 Jun 2024
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (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 MalariaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomised placebo-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 5,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Africa Power Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Malaria Consortium, ARCTECH INNOVATION LIMITED
- Responsible party
- Sponsor
- Investigators
- Robert Jones, PhD, Principal investigator, Arctech InnovationJane Achan, PhD, Principal investigator, Malaria Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232954
- Sponsor's protocol ID
- 1577
- Acronym
- Mossie-GO
- Status last verified
- Jun 2024
- First submitted
- 4 Jan 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dennehy J, Dyall W, Jenkins A, Bradley J, Sserwanga A, Kigozi R, Bwanika JB, Nuwa A, Mawejje H, Turner MA, Wallace R, Lyle FGA, Hiscox A, Livesey AK, Logan JG, Achan J, Jones RT. Evaluation of the protective efficacy of a transfluthrin-based spatial repellent product to reduce malaria prevalence in Uganda: study protocol for a cluster-randomised double-blinded control trial-the Mossie-GO trial. Trials. 2026 Feb 3;27(1):189. doi: 10.1186/s13063-025-09365-w.
PubMed 41634736
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Protective Efficacy of a Spatial Repellent to Reduce Malaria Prevalence in Children ≤ 5 Years of Age in Uganda: Study Protocol for a Cluster-randomized Double-blinded Control Trial: The Mossie-GO Trial
- ClinicalTrials.gov ID
- NCT06232954
- Acronym / sponsor ID
- Mossie-GO / 1577
- Conditions
- Malaria, Mosquito-Borne Disease
- Keywords
- malaria, spatial repellent, vector control, transfluthrin, randomised control trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,600 participants (estimated)
- Lead sponsor
- Africa Power LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Malaria Consortium, ARCTECH INNOVATION LIMITED
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 31 Jan 2024 (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 cluster-randomized double-blinded control trial will be conducted in Uganda to demonstrate and quantify the protective efficacy (PE) of Mossie-GO, an active spatial repellent system disseminating transfluthrin, in reducing the prevalence of malaria in children ≤ 5 years of age, as determined by RDT positivity and confirmed by microscopy. The study's secondary objective is to measure the diversionary impact of the intervention on locally unprotected individuals and impact of the intervention on entomological correlates of transmission including vector densities, host seeking behaviour and insecticide resistance. This will be conducted using Centre of Disease Control (CDC) light traps in households, human landing catches and World Health Organisation (WHO) tube tests. Further data collection include household behavioural surveys, air sampling to quantify concentration of transfluthrin present in air, acceptability surveys and intervention safety monitoring.
Recruited households will be monitored across baseline data collection and followed up for 2 disease transmission seasons, for up to 18 months. The devices will be distributed to all consented eligible households in the two study arms: intervention and control. Intervention arm devices will be provided with transfluthrin treated discs and refill transfluthrin discs at frequent enough intervals to provide sustained protection. Households in the control arm will receive blank discs with no active ingredient. Households will be asked to continue using other malaria prevention practices, such as the use of bed nets, as recommended by national policy.
Detailed description
The impact of Mossie-GO on malaria cases will be determined through a blinded cluster randomized trial in malaria endemic settings. The device will be distributed to all consented eligible households in the two study arms: intervention and control. Intervention arm devices will be provided with transfluthrin treated discs and refill transfluthrin discs at frequent enough intervals to provide sustained protection. Households in the control arm will receive blank discs with no active ingredient and refill blank discs to maintain study blinding.
The Mossie-GO repellent device is approximately 8 cm3 and can be fitted with repellent discs impregnated with transfluthrin and a carrier oil. These discs sit above a fan that is powered by a small motor charged by solar energy. The device is expected to both prevent bites and cause some mortality to mosquitoes when switched on for 8-12 hours overnight for up to 1 calendar month. The discs then need to be replaced. One Mossie-GO device will be provided per household, along with a solar cell unit that will be connected to the Mossie-GO unit and must be placed in direct sunlight to charge the Mossie-Go unit during the day, for use in the evening. Households will be asked to continue using other malaria prevention practices, such as bed nets, as recommended by national policy.
At baseline, Mossie-GO will be distributed at the household level and should be placed in the room of the participant enrolled into the study (child ≤ 5 years of age) while they are sleeping. At the same time a baseline survey will be conducted and children ≤ 5 years of age will be tested for malaria using RDTs and microscopy, to determine baseline malaria prevalence. At this time, household surveys will also be conducted to classify housing structure and collect other variables which may impact the efficacy of the intervention. Following this period, sample size estimates may be adjusted based on malaria prevalence. All recruited households will be monitored at 6-monthly intervals and malaria testing will be done among children ≤ 5 years of age with RDTs and microscopy over a period of up to 18 months. Indoor light traps will be installed in selected households for approximately 3-4 nights in the 6 month intervals and run from 6pm to 7 am to collect mosquitoes indoors, and human landing catches will be conducted. Air sampling will also be conducted alongside mosquito collections to quantify the concentrations of transfluthrin in the air and to help inform entomological and epidemiological outcomes. An acceptability survey will also be conducted at the final data collection time point
The unit of randomization is a cluster, which is defined as a discrete village or area containing a minimum of 100 households. Clusters will be divided into core and buffer zones. Twenty eight clusters will be identified per study arm (treatment and control), thus fifty six clusters will be selected in total. Households within the core zone of clusters will receive the Mossie-GO device (intervention or control). Households within the buffer zones will not receive the Mossie-GO. While all households within the core zone of the cluster are receiving the device, they will not all be sampled for the evaluation of the primary objective (PE). Only a total of 100 eligible, consenting households will be sampled within the core zones. Household surveys will also be conducted in these 100 households. For the evaluation of the secondary outcomes, a subset of houses will be selected. Diversionary impact: 100 households in buffer zone; entomological sampling: 10% of households in core zone; air sampling 1 household every 500m in core zone.
The primary outcome (PE) will be compared between arms using logistic regression with a random effect for study cluster and adverse event data will be collected and summarised.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Cluster-randomised placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Mossie-Go containing treated transfluthrin discAll recruited households within the intervention arm will receive the Mossie-Go device containing transfluthrin treated discs and will be provided with refill transfluthrin discs at monthly intervals to provide sustained protection. |
| Control | Placebo comparator | Device: Mossie-Go containing untreated blank discAll recruited households within the control arm will receive the Mossie-Go device containing untreated blank discs and will be provided with refill untreated blank discs at monthly intervals. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Number of households > 100
- Presence of a child ≤ 5 years of age at point of enrolment in the study
- Adult head of household agrees to receiving and using the device as per manual instructions
- Adult head of household agrees to data collection visits and household surveys
- Children within household sleeps in cluster > 90% of nights during any given month
Key exclusion criteria (13 listed)
- Number of households < 100
- Presence of a child > 5 years of age at point of enrolment in the study
- Adult head of household does not agree to data collection visits and household surveys
- Children within household sleeps in cluster < 90% of nights during any given month
- Households where study personnel identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile).
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 |
|---|---|---|
| Mossie-Go containing treated transfluthrin discThe Mossie-GO repellent device is approximately 8 cm3 and can be fitted with repellent discs impregnated with transfluthrin and a carrier oil. These discs sit above a fan that is powered by a small motor charged by solar energy. The device is expected to both prevent bites and cause some mortality to mosquitoes when switched on for 8-12 hours overnight for up to 1 calendar month. The discs then need to be replaced. | Device | Intervention |
| Mossie-Go containing untreated blank discThe Mossie-GO repellent device is approximately 8 cm3 and can be fitted with a blank untreated disc. These discs sit above a fan that is powered by a small motor charged by solar energy. The device containing the untreated disc is not expected to prevent mosquito bites. The discs will still be replaced monthly for blinding purposes. | Device | Control |
Primary outcome
Malaria prevalence
Time frame: 18 months
Malaria prevalence among children ≤ 5 years of age as determined by Rapid Diagnostic Test (RDT) positivity and confirmed by microscopy.
6 secondary outcomes
Assessment of the diversionary effect of spatial repellent in the buffer zone using RDT and microscopy
Time frame: 18 months
Entomological correlates of transmission
Time frame: 18 months
Household surveys
Time frame: 18 months
Air sampling
Time frame: 18 months
Safety of intervention
Time frame: 18 months
Acceptability survey
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Derived from this study: PubMed 41634736Dennehy J, Dyall W, Jenkins A, Bradley J, Sserwanga A, Kigozi R, Bwanika JB, Nuwa A, Mawejje H, Turner MA, Wallace R, Lyle FGA, Hiscox A, Livesey AK, Logan JG, Achan J, Jones RT. Evaluation of the protective efficacy of a transfluthrin-based spatial repellent product to reduce malaria prevalence in Uganda: study protocol for a cluster-randomised double-blinded control trial-the Mossie-GO trial. Trials. 2026 Feb 3;27(1):189. doi: 10.1186/s13063-025-09365-w.
- Individual participant dataSharing planned: No
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
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.
Jane Achan, PhD contact
Robert Jones, PhD principal investigator
Arctech Innovation
Jane Achan, PhD principal investigator
Malaria Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mossie-Go containing treated transfluthrin disc and Mossie-Go containing untreated blank disc in people with Malaria and Mosquito-Borne Disease, run by Africa Power Limited at 1 site in Uganda.
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 13 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 21 Jun 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 Uganda. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Jones, PhD (+447745845880, robert.jones@arctechinnovation.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malaria prevalence (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06232954, 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 21 Jun 2024.