Malaria,FalciparumPhase 2NECTAR4NCT05550909
Gametocytocidal and Transmission-blocking Efficacy of ASAQ and ALAQ With or Without PQ in Mali
A Phase 2 study testing Artesunate-amodiaquine combination, Primaquine Phosphate and Artemether-lumefantrine in people with Malaria,Falciparum, run by London School of Hygiene and Tropical Medicine at 1 site in Mali.
Trial summary
The purpose of this study is to compare the gametocytocidal and transmission reducing activity of artesunate-amodiaquine (ASAQ) and artemether-lumefantrine-amodiaquine (ALAQ) with and without a single dose of 0.25mg/kg primaquine (PQ). Read more about this study
- Who is it for?
- Ages 10 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum
- What is being tested?
- Artesunate-amodiaquine combination, Primaquine Phosphate and Artemether-lumefantrine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMali
- Study dates
- 17 Oct 2022to 26 Jan 2023
- Phase
- Phase 2
- 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 10 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age ≥ 10 years and ≤ 50 years
- Absence of symptomatic falciparum malaria, defined by fever on enrolment
- Presence of P. falciparum gametocytes on thick blood film at a density >16 gametocytes/µL (i.e. ≥ gametocytes recorded in the thick film against 500 white blood cells)
- Absence of other non-P. falciparum species on blood film
- Haemoglobin ≥ 10 g/dL
- Individuals weighing < = 80 kg
- No evidence of acute severe or chronic disease
- Written, informed consent
Who cannot join
- Women who are pregnant or lactating (tested at baseline). Urine and/or serum pregnancy testing (β-hCG) will be used.
- Detection of a non-P. falciparum species by microscopy
- Previous reaction to study drugs / known allergy to study drugs, such as sudden high fevers, shaking or severe sore throat or ulcers in the mouth during treatment with Amodiaquine
- Current eye disease with retinal damage
- Signs of severe malaria, including hyperparasitaemia (defined as asexual parasitaemia > 100,000 parasites / µL)
- Signs of acute or chronic illness, including hepatitis
Show all 16Show fewer
- The use of other medication (except for paracetamol and/or aspirin), including antacids, other medicines used to treat malaria, abnormal heart rhythm, depression or mental illness or HIV/AIDS, and medicines that have antibiotic/antifungal properties
- Use of antimalarial drugs over the past 7 days (as reported by the participant)
- Clinically significant illness (intercurrent illness e.g., pneumonia, pre-existing condition e.g., renal disease or HIV/AIDS, malignancy or conditions that may affect absorption of study medication e.g., severe diarrhoea or any signs of malnutrition as defined clinically)
- Signs of hepatic injury (such as nausea and/or abdominal pain associated with jaundice) or known severe liver disease (i.e., decompensated cirrhosis, Child Pugh stage B or C)
- Signs, symptoms or known renal impairment
- Clinically significant abnormal laboratory values as determined by history, physical examination, or routine blood chemistries and haematology values (laboratory guideline values for exclusion are haemoglobin < 10 g/dL, platelets < 50,000/μl, White Blood Cell count (WBC) < 2000/μl, serum creatinine >2.0mg/dL, or ALT more than 3 times the upper limit of normal for age.
- Blood transfusion in the last 90 days.
- Known Electrocardiogram (ECG) corrected QT interval of more than 450 ms
- Documented or self-reported history of cardiac conduction problems
- Documented or self-reported history of epileptic seizures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Five-arm Trial Comparing Artesunate-amodiaquine and Artemether-lumefantrine-amodiaquine With or Without Single-dose Primaquine to Reduce P. Falciparum Transmission in Mali
The purpose of this study is to compare the gametocytocidal and transmission reducing activity of artesunate-amodiaquine (ASAQ) and artemether-lumefantrine-amodiaquine (ALAQ) with and without a single dose of 0.25mg/kg primaquine (PQ). Outcome measures will include infectivity to mosquitoes at 2, 7 and 14 days after treatment, gametocyte density throughout follow-up, and safety measures including haemoglobin density and the frequency of adverse events.
Read the detailed description
Full protocol available on request
- Conditions
- Malaria,Falciparum
- Being tested
- Artesunate-amodiaquine combination, Primaquine Phosphate, Artemether-lumefantrine, Amodiaquine
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate-amodiaquine combinationDrug
Also called Camoquin
Tablets containing 50mg/135 mg or 100mg/270 mg of artesunate/amodiaquine will be administered according to weight as per manufacturer guidelines
Primaquine PhosphateDrug
Also called Primaquine
The single dose of 0.25mg/kg PQ will be administered in an aqueous solution, according to a standard operating procedure (SOP) provided by the manufacturer.
Artemether-lumefantrineDrug
Also called Coartem
Tablets containing 20 mg artemether and 120 mg lumefantrine will be administered according to weight as per manufacturer guidelines
AmodiaquineDrug
Tablets containing 153 mg of amodiaquine will be administered according to weight, aiming for a dosage of approximately 10 mg (7.7-15.3mg)/kg/day, given once or twice daily (together with artemether-lumefantrine) for three days.
| Study group | Role | What they receive |
|---|---|---|
| artesunate-amodiaquine (ASAQ) | Active comparator | Subjects will receive artesunate-amodiaquine (ASAQ) daily for 3 days. Receives: Drug: Artesunate-amodiaquine combination |
| ASAQ with 0.25mg/kg primaquine (PQ) | Experimental | Subjects will receive artesunate-amodiaquine (ASAQ) daily for 3 days and a single dose of 0.25mg/kg primaquine (PQ) on the first day of ASAQ treatment. Receives: Drug: Artesunate-amodiaquine combination; Drug: Primaquine Phosphate |
| Artemether-Lumefantrine (AL) | Active comparator | Subjects will receive artemether-lumefantrine (AL) twice daily for 3 days. Receives: Drug: Artemether-lumefantrine |
| Artemether-Lumefantrine-Amodiaquine (ALAQ) | Experimental | Subjects will receive artemether-lumefantrine (AL) and amodiaquine (AQ) twice daily for 3 days. Receives: Drug: Artemether-lumefantrine; Drug: Amodiaquine |
| Artemether-Lumefantrine-Amodiaquine (ALAQ) with 0.25 mg/kg primaquine (PQ) | Experimental | Subjects will receive artemether-lumefantrine (AL) and amodiaquine (AQ) twice daily for 3 days and a single dose of 0.25mg/kg primaquine (PQ) on the first day of ALAQ treatment. Receives: Drug: Primaquine Phosphate; Drug: Artemether-lumefantrine; Drug: Amodiaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mosquito infection rate assessed through membrane feeding assays
Within person percent change (presented as percent reduction) in mosquito infection rate in infectious individuals from baseline (day 0, pre-treatment) to day 2 post treatment in the ASAQ, ASAQ-PQ, AL, ALAQ and ALAQ-PQ arms.
Measured: 2 days (days 0 and 2): 3 day span
Secondary outcomes (13)
Change in mosquito infection rate assessed through membrane feeding assays (all timepoints)
Within person percent change (presented as percent reduction) in mosquito infection rate from baseline to all feeding time-points, with comparison within and between arms.
Measured: 6 days (day 0, day 2, day 7, day 14, day 21, day 28): 28 day span
Mosquito infection rate assessed through membrane feeding assays
Mosquito infection rate at all feeding time-points, with comparison within treatment arms compared to baseline, and between arms.
Measured: 6 days (day 0, day 2, day 7, day 14, day 21, day 28): 28 day span
Human infectivity to locally reared mosquitoes assessed through membrane feeding assays
Infectivity to mosquitoes at all feeding time-points, with comparison within treatment arms compared to baseline, and between arms.
Measured: 6 days (day 0, day 2, day 7, day 14, day 21, day 28): 28 day span
Mosquito infection density assessed through membrane feeding assays
Oocyst intensity (in all/all infected mosquitoes) at all feeding time-points, with comparison within treatment arms compared to baseline, and between arms.
Measured: 6 days (day 0, day 2, day 7, day 14, day 21, day 28): 28 day span
Gametocyte infectivity
Infectiousness to mosquitoes for a given gametocyte density (measured as mosquito infection rate/gametocyte) at all feeding time-points, with comparison within treatment arms compared to baseline, and between arms.
Measured: 6 days (day 0, day 2, day 7, day 14, day 21, day 28): 28 day span
Asexual/sexual stage parasite prevalence
Male and female gametocyte prevalence at all time-points, determined by microscopy or molecular assays, with comparison within treatment arms compared to baseline, and between arms.
Asexual and total parasite prevalence at all time-points, determined by microscopy or molecular assays, with comparison within treatment arms compared to baseline, and between arms.
Measured: 6 days (day 0, day 2, day 7, day 14, day 21, day 28): 28 day span
Asexual/sexual stage parasite density
Male and female gametocyte density at all time-points, determined by microscopy or molecular assays, with comparison within treatment arms compared to baseline, and between arms.
Asexual and total parasite density at all time-points, determined by microscopy or molecular assays, with comparison within treatment arms compared to baseline, and between arms.
Measured: 6 days (day 0, day 2, day 7, day 14, day 21, day 28): 28 day span
Sexual stage parasite sex ratio
Male and female gametocyte sex ratio (proportion male) at all time-points, determined by microscopy or molecular assays, with comparison within treatment arms compared to baseline, and between arms.
Measured: 6 days (day 0, day 2, day 7, day 14, day 21, day 28): 28 day span
Sexual stage parasite circulation time
Gametocyte circulation time (cumulative), determined by microscopy or molecular assays, compared within and between treatment arms.
Measured: 6 days (day 0, day 2, day 7, day 14, day 21, day 28): 28 day span
Sexual stage parasite area under the curve (AUC)
Gametocyte area under the curve (cumulative), determined by microscopy or molecular assays, compared within and between treatment arms.
Measured: 6 days (day 0, day 2, day 7, day 14, day 21, day 28): 28 day span
Haemoglobin density
Haemoglobin density (g/dL) at all time-points, with comparison within treatment arms compared to baseline, and between arms.
Measured: 7 days (day 0, day 1, day 2, day 7, day 14, day 21, day 28): 28 day span
Change in haemoglobin density
Within person percent change (presented as percent reduction) in haemoglobin density (g/dL) from baseline to all time-points, with comparison within and between arms.
Measured: 7 days (day 0, day 1, day 2, day 7, day 14, day 21, day 28): 28 day span
Incidence of adverse events
The frequency and prevalence of adverse events (all AE's, treatment related AE's, and haematological AE's) observed up to and including day 2, 7, and 14 post-treatment, and at all timepoints.
Measured: 7 days (day 0, day 1, day 2, day 7, day 14, day 21, day 28): 28 day span
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start17 Oct 2022
- Primary completion30 Dec 2022
- Study completion26 Jan 2023
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 Malaria,FalciparumStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alassane Dicko, Principal investigator, Malaria Research and Training Center, Bamako, Mali
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550909
- Sponsor's protocol ID
- 28041
- Acronym
- NECTAR4
- Status last verified
- Nov 2022
- First submitted
- 15 Sep 2022
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised individual participant data may be shared on a digital repository or upon reasonable request.
Publications
Mahamar A, Vanheer LN, Smit MJ, Sanogo K, Sinaba Y, Niambele SM, Diallo M, Dicko OM, Diarra RS, Maguiraga SO, Youssouf A, Sacko A, Keita S, Samake S, Dembele A, Teelen K, Dicko Y, Traore SF, Dondorp A, Drakeley C, Stone W, Dicko A. Artemether-lumefantrine-amodiaquine or artesunate-amodiaquine combined with single low-dose primaquine to reduce Plasmodium falciparum malaria transmission in Ouelessebougou, Mali: a five-arm, phase 2, single-blind, randomised controlled trial. Lancet Microbe. 2025 Feb;6(2):100966. doi: 10.1016/j.lanmic.2024.100966. Epub 2024 Dec 17.
PubMed 39701119
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Five-arm Trial Comparing Artesunate-amodiaquine and Artemether-lumefantrine-amodiaquine With or Without Single-dose Primaquine to Reduce P. Falciparum Transmission in Mali
- ClinicalTrials.gov ID
- NCT05550909
- Acronym / sponsor ID
- NECTAR4 / 28041
- Conditions
- Malaria,Falciparum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 22 Sep 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.
The purpose of this study is to compare the gametocytocidal and transmission reducing activity of artesunate-amodiaquine (ASAQ) and artemether-lumefantrine-amodiaquine (ALAQ) with and without a single dose of 0.25mg/kg primaquine (PQ). Outcome measures will include infectivity to mosquitoes at 2, 7 and 14 days after treatment, gametocyte density throughout follow-up, and safety measures including haemoglobin density and the frequency of adverse events.
Detailed description
Full protocol available on request
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| artesunate-amodiaquine (ASAQ) | Active comparator | Drug: Artesunate-amodiaquine combinationSubjects will receive artesunate-amodiaquine (ASAQ) daily for 3 days. |
| ASAQ with 0.25mg/kg primaquine (PQ) | Experimental | Drug: Artesunate-amodiaquine combination, Drug: Primaquine PhosphateSubjects will receive artesunate-amodiaquine (ASAQ) daily for 3 days and a single dose of 0.25mg/kg primaquine (PQ) on the first day of ASAQ treatment. |
| Artemether-Lumefantrine (AL) | Active comparator | Drug: Artemether-lumefantrineSubjects will receive artemether-lumefantrine (AL) twice daily for 3 days. |
| Artemether-Lumefantrine-Amodiaquine (ALAQ) | Experimental | Drug: Artemether-lumefantrine, Drug: AmodiaquineSubjects will receive artemether-lumefantrine (AL) and amodiaquine (AQ) twice daily for 3 days. |
| Artemether-Lumefantrine-Amodiaquine (ALAQ) with 0.25 mg/kg primaquine (PQ) | Experimental | Drug: Primaquine Phosphate, Drug: Artemether-lumefantrine, Drug: AmodiaquineSubjects will receive artemether-lumefantrine (AL) and amodiaquine (AQ) twice daily for 3 days and a single dose of 0.25mg/kg primaquine (PQ) on the first day of ALAQ treatment. |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age ≥ 10 years and ≤ 50 years
- Absence of symptomatic falciparum malaria, defined by fever on enrolment
- Presence of P. falciparum gametocytes on thick blood film at a density >16 gametocytes/µL (i.e. ≥ gametocytes recorded in the thick film against 500 white blood cells)
- Absence of other non-P. falciparum species on blood film
- Haemoglobin ≥ 10 g/dL
Key exclusion criteria (16 listed)
- Women who are pregnant or lactating (tested at baseline). Urine and/or serum pregnancy testing (β-hCG) will be used.
- Detection of a non-P. falciparum species by microscopy
- Previous reaction to study drugs / known allergy to study drugs, such as sudden high fevers, shaking or severe sore throat or ulcers in the mouth during treatment with Amodiaquine
- Current eye disease with retinal damage
- Signs of severe malaria, including hyperparasitaemia (defined as asexual parasitaemia > 100,000 parasites / µL)
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 |
|---|---|---|
| Artesunate-amodiaquine combinationAlso: CamoquinTablets containing 50mg/135 mg or 100mg/270 mg of artesunate/amodiaquine will be administered according to weight as per manufacturer guidelines | Drug | ASAQ with 0.25mg/kg primaquine (PQ), artesunate-amodiaquine (ASAQ) |
| Primaquine PhosphateAlso: PrimaquineThe single dose of 0.25mg/kg PQ will be administered in an aqueous solution, according to a standard operating procedure (SOP) provided by the manufacturer. | Drug | ASAQ with 0.25mg/kg primaquine (PQ), Artemether-Lumefantrine-Amodiaquine (ALAQ) with 0.25 mg/kg primaquine (PQ) |
| Artemether-lumefantrineAlso: CoartemTablets containing 20 mg artemether and 120 mg lumefantrine will be administered according to weight as per manufacturer guidelines | Drug | Artemether-Lumefantrine (AL), Artemether-Lumefantrine-Amodiaquine (ALAQ), Artemether-Lumefantrine-Amodiaquine (ALAQ) with 0.25 mg/kg primaquine (PQ) |
| AmodiaquineTablets containing 153 mg of amodiaquine will be administered according to weight, aiming for a dosage of approximately 10 mg (7.7-15.3mg)/kg/day, given once or twice daily (together with artemether-lumefantrine) for three days. | Drug | Artemether-Lumefantrine-Amodiaquine (ALAQ), Artemether-Lumefantrine-Amodiaquine (ALAQ) with 0.25 mg/kg primaquine (PQ) |
Primary outcome
Change in mosquito infection rate assessed through membrane feeding assays
Time frame: 2 days (days 0 and 2): 3 day span
Within person percent change (presented as percent reduction) in mosquito infection rate in infectious individuals from baseline (day 0, pre-treatment) to day 2 post treatment in the ASAQ, ASAQ-PQ, AL, ALAQ and ALAQ-PQ arms.
13 secondary outcomes
Change in mosquito infection rate assessed through membrane feeding assays (all timepoints)
Time frame: 6 days (day 0, day 2, day 7, day 14, day 21, day 28): 28 day span
Mosquito infection rate assessed through membrane feeding assays
Time frame: 6 days (day 0, day 2, day 7, day 14, day 21, day 28): 28 day span
Human infectivity to locally reared mosquitoes assessed through membrane feeding assays
Time frame: 6 days (day 0, day 2, day 7, day 14, day 21, day 28): 28 day span
Mosquito infection density assessed through membrane feeding assays
Time frame: 6 days (day 0, day 2, day 7, day 14, day 21, day 28): 28 day span
Gametocyte infectivity
Time frame: 6 days (day 0, day 2, day 7, day 14, day 21, day 28): 28 day span
Asexual/sexual stage parasite prevalence
Time frame: 6 days (day 0, day 2, day 7, day 14, day 21, day 28): 28 day span
Asexual/sexual stage parasite density
Time frame: 6 days (day 0, day 2, day 7, day 14, day 21, day 28): 28 day span
Sexual stage parasite sex ratio
Time frame: 6 days (day 0, day 2, day 7, day 14, day 21, day 28): 28 day span
Sexual stage parasite circulation time
Time frame: 6 days (day 0, day 2, day 7, day 14, day 21, day 28): 28 day span
Sexual stage parasite area under the curve (AUC)
Time frame: 6 days (day 0, day 2, day 7, day 14, day 21, day 28): 28 day span
Haemoglobin density
Time frame: 7 days (day 0, day 1, day 2, day 7, day 14, day 21, day 28): 28 day span
Change in haemoglobin density
Time frame: 7 days (day 0, day 1, day 2, day 7, day 14, day 21, day 28): 28 day span
Incidence of adverse events
Time frame: 7 days (day 0, day 1, day 2, day 7, day 14, day 21, day 28): 28 day span
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 1 Oct 2024.
- Derived from this study: PubMed 39701119Mahamar A, Vanheer LN, Smit MJ, Sanogo K, Sinaba Y, Niambele SM, Diallo M, Dicko OM, Diarra RS, Maguiraga SO, Youssouf A, Sacko A, Keita S, Samake S, Dembele A, Teelen K, Dicko Y, Traore SF, Dondorp A, Drakeley C, Stone W, Dicko A. Artemether-lumefantrine-amodiaquine or artesunate-amodiaquine combined with single low-dose primaquine to reduce Plasmodium falciparum malaria transmission in Ouelessebougou, Mali: a five-arm, phase 2, single-blind, randomised controlled trial. Lancet Microbe. 2025 Feb;6(2):100966. doi: 10.1016/j.lanmic.2024.100966. Epub 2024 Dec 17.
- Individual participant dataSharing planned: No. Anonymised individual participant data may be shared on a digital repository or upon reasonable request.
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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.
Alassane Dicko principal investigator
Malaria Research and Training Center, Bamako, Mali
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Artesunate-amodiaquine combination, Primaquine Phosphate and Artemether-lumefantrine in people with Malaria,Falciparum, run by London School of Hygiene and Tropical Medicine at 1 site in Mali.
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 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 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 Mali. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 mosquito infection rate assessed through membrane feeding assays (time frame: 2 days (days 0 and 2): 3 day span). 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 NCT05550909, 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 1 Oct 2024.