Neuropathy, DiabeticMEDONNCT04078516
Methods of Early Detection and Grading Of Diabetic Peripheral Neuropathy (MEDON)
An observational study of Neuropathy, Diabetic and Neuropathy, Painful, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
MEDON aims to examine new methods for early detection and grading of diabetic peripheral neuropathy focusing on both small- and large nerve fibers. Furthermore, MEDON aims to describe differences between people with classic diabetic peripheral neuropathy and those with painful diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropathy, Diabetic, Neuropathy, Painful
- What is being tested?
- Perception Threshold Tracking (PTT), Axon-flair mediated respons and Heart rate variability
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Aug 2019to 31 Aug 2021
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population include four well-defined groups of subjects: 1. Patients with Type 1 diabetes and painful diabetic peripheral neuropathy (DPN). 2. Patients with Type 1 diabetes and non-painful diabetic peripheral neuropathy (DPN) 3. Patients with Type 1 diabetes and without diabetic peripheral neuropathy (VPT<15) (DPN). 4. Healthy control subjects matched for age, BMI, and gender. Diabetes duration, HbA1c, insulin use, ethnicity, and co-morbidities will be matched between group 1, 2 and 3 to best ability.
Who may be able to join
- Men and women minimum 18 years of age and maximum 75 years of age
- Signed informed consent form
- Diagnosed with diabetes type I (for group 1-3)
- Diagnosed with DPN defined as a threshold above 25-volt biothesiometry or absent feeling on the big toe using 10g-monofilament. (for group 1-2)
- Answered questionnaire: PainDETECT
- Nothing abnormal on initial tests (group 4)
- Accepted initial screening blood samples
- MRI-compatible participant
Who cannot join
- 1. Current or previous alcohol- or drug abuse 2. Abnormal screening blood samples 3. Not being able to understand Danish written and/or verbally 4. Not being able to corporate to examination (e.g. not being able to speak, suffering from senile dementia etc.) 5. Previous chemotherapy or intake of experimental medicine 6. Active HSV- or VZV-infection or known HIV 7. Known severe skin disease 8. Known neural damage or disease in the neural system (e.g. MS, Guillain-Barre etc.) 9. Critical limb ischemia defined as in current clinical consensus 10. Allergy or intolerance to histamine or inability to make do without for one day 11. Pregnancy 12. Active cancer-disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perception Threshold Tracking(PTT): A Novel Method for Early Detection and Grading of Diabetic Peripheral Neuropathy
MEDON aims to examine new methods for early detection and grading of diabetic peripheral neuropathy focusing on both small- and large nerve fibers. Furthermore, MEDON aims to describe differences between people with classic diabetic peripheral neuropathy and those with painful diabetic neuropathy.
- Conditions
- Neuropathy, Diabetic, Neuropathy, Painful
- Being tested
- Perception Threshold Tracking (PTT), Axon-flair mediated respons, Heart rate variability, Quantitative Sensory Testing (QST), Peripheral blood pressure and transcutaneous oxygen tension
- Keywords
- diabetes, neuropathy, early detection, small nerve fibers
- Medical subject headings
- Diabetic Neuropathies, Neuropathy, Painful, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perception Threshold Tracking (PTT)Diagnostic test
low-current electrical stimulation of both large- and small nerve fibers.
Axon-flair mediated responsDiagnostic test
Also called Laser-doppler
Laser-doppler examination of small blood vessels in the peripheral skin.
Heart rate variabilityDiagnostic test
Also called Vagus TM
4 measurements of heart rate.
Quantitative Sensory Testing (QST)Diagnostic test
Also called German Research Network on Neuropathic Pain (DFNS) standard protocol
Seven tests measuring 13 parameters including heat- and cold-detection and pain thresholds, mechanical pain treshold, mechanical detection threshold, pressure pain treshold and vibration threshold.
Peripheral blood pressure and transcutaneous oxygen tensionDiagnostic test
Also called Perimed 6000
Ankle/brachial index, toe/brachial index, TcpO2.
Magnetic Resonance Imaging (MRI)Diagnostic test
MRI-scans of peripheral nerves and the central nervous system. Blood oxygen level dependent (BOLD) MRI.
QuestionnairesDiagnostic test
Also called PainDETECT, Douleur Neuropathique 4
Questionnaires for detecting painful neuropathy
Corneal Confocal Microscopy /CCM)Diagnostic test
Confocal microscopy of the cornea measuring NBD, NFD, NFL
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes and painful neuropathy | No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied. Receives: Diagnostic Test: Perception Threshold Tracking (PTT); Diagnostic Test: Axon-flair mediated respons; Diagnostic Test: Heart rate variability; Diagnostic Test: Quantitative Sensory Testing (QST); Diagnostic Test: Peripheral blood pressure and transcutaneous oxygen tension; Diagnostic Test: Magnetic Resonance Imaging (MRI); Diagnostic Test: Questionnaires; Diagnostic Test: Corneal Confocal Microscopy /CCM) | |
| Type 1 diabetes and non-painful neuropathy | No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied. Receives: Diagnostic Test: Perception Threshold Tracking (PTT); Diagnostic Test: Axon-flair mediated respons; Diagnostic Test: Heart rate variability; Diagnostic Test: Quantitative Sensory Testing (QST); Diagnostic Test: Peripheral blood pressure and transcutaneous oxygen tension; Diagnostic Test: Magnetic Resonance Imaging (MRI); Diagnostic Test: Questionnaires; Diagnostic Test: Corneal Confocal Microscopy /CCM) | |
| Type 1 diabetes and no neuropathy | No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied. Receives: Diagnostic Test: Perception Threshold Tracking (PTT); Diagnostic Test: Axon-flair mediated respons; Diagnostic Test: Heart rate variability; Diagnostic Test: Quantitative Sensory Testing (QST); Diagnostic Test: Peripheral blood pressure and transcutaneous oxygen tension; Diagnostic Test: Magnetic Resonance Imaging (MRI); Diagnostic Test: Questionnaires; Diagnostic Test: Corneal Confocal Microscopy /CCM) | |
| Matched controls without diabetes | No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied. Receives: Diagnostic Test: Perception Threshold Tracking (PTT); Diagnostic Test: Axon-flair mediated respons; Diagnostic Test: Heart rate variability; Diagnostic Test: Quantitative Sensory Testing (QST); Diagnostic Test: Peripheral blood pressure and transcutaneous oxygen tension; Diagnostic Test: Magnetic Resonance Imaging (MRI); Diagnostic Test: Questionnaires; Diagnostic Test: Corneal Confocal Microscopy /CCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value of CCM, PTT, AF and MRI
Using Quantitative Sensory Testing (small fibers) and conventional nerve conduction studies (large fibers) as golden standards, we will determine the prognostic value of:
Perception Threshold Tracking Corneal Confocal Microscopy Axon-flair mediated response MRI-scans in detecting neuropathy. Sensitivity and specificity will be reported.
OBS! Tests will be tested in the initial groups and AFTER a group re-arrangement based on results from QST and NCS.
Measured: End of study (when all patients have completed all sessions. Latest 31. december 2021)
Secondary outcomes (1)
Validation of PainDETECT in diabetes
Correlation between PainDETECT and DN4 will be reported.
Measured: End of study / end of inclusion (when all patients have completed the screening session. Latest 31. november 2021)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start12 Aug 2019
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neuropathy, DiabeticStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Principal investigator, Niels Ejskjær, Aalborg University Hospital
- Investigators
- Niels Ejskjær, Professor, Principal investigator, Steno Diabtes Center North Denmark, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078516
- Sponsor's protocol ID
- N-20190003
- Acronym
- MEDON
- Status last verified
- Nov 2021
- First submitted
- 28 Aug 2019
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with collaborating department: Department of Radiology with the purpose of analyzing the data and comparing it to their MRI scans. Data will be shared with Aalborg University with the purpose of analyzing data.
Publications
Moussa F, Taleb S, Borbjerg MK, Croosu SS, Morch CD, Frokjaer JB, Hansen TM, Ejskjaer N, Roikjer J. Corneal Immune Cells and Their Relation to Diabetic Peripheral Neuropathy and Neuropathic Pain. Muscle Nerve. 2026 Jan;73(1):72-78. doi: 10.1002/mus.70061. Epub 2025 Nov 17.
PubMed 41246983Hostrup SN, Lind HP, Croosu SS, Roikjer J, Morch CD, Ejskjaer N, Ostergaard LR, Hansen TM, Frokjaer JB. Multimodal MRI analysis selecting key brain features for machine learning based classification of diabetic neuropathic pain and phenotypes. J Neurol Sci. 2025 Nov 15;478:123701. doi: 10.1016/j.jns.2025.123701. Epub 2025 Sep 15.
PubMed 40987057Roikjer J, Croosu SS, Sejergaard BF, Hansen TM, Frokjaer JB, Sondergaard CB, Petropoulos IN, Malik RA, Nielsen E, Morch CD, Ejskjaer N. Diagnostic Accuracy of Perception Threshold Tracking in the Detection of Small Fiber Damage in Type 1 Diabetes. J Diabetes Sci Technol. 2024 Sep;18(5):1157-1164. doi: 10.1177/19322968231157431. Epub 2023 Feb 24.
PubMed 36825610Roikjer J, Croosu SS, Frokjaer JB, Hansen TM, Arendt-Nielsen L, Ejskjaer N, Morch CD. Perception threshold tracking: validating a novel method for assessing function of large and small sensory nerve fibers in diabetic peripheral neuropathy with and without pain. Pain. 2023 Apr 1;164(4):886-894. doi: 10.1097/j.pain.0000000000002780. Epub 2022 Sep 19.
PubMed 36130086
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception Threshold Tracking(PTT): A Novel Method for Early Detection and Grading of Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT04078516
- Acronym / sponsor ID
- MEDON / N-20190003
- Conditions
- Neuropathy, Diabetic, Neuropathy, Painful
- Keywords
- diabetes, neuropathy, early detection, small nerve fibers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 6 Sep 2019 (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.
MEDON aims to examine new methods for early detection and grading of diabetic peripheral neuropathy focusing on both small- and large nerve fibers. Furthermore, MEDON aims to describe differences between people with classic diabetic peripheral neuropathy and those with painful diabetic neuropathy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes and painful neuropathy | – | Diagnostic Test: Perception Threshold Tracking (PTT), Diagnostic Test: Axon-flair mediated respons, Diagnostic Test: Heart rate variability, Diagnostic Test: Quantitative Sensory Testing (QST), Diagnostic Test: Peripheral blood pressure and transcutaneous oxygen tension, Diagnostic Test: Magnetic Resonance Imaging (MRI), Diagnostic Test: Questionnaires, Diagnostic Test: Corneal Confocal Microscopy /CCM)No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied. |
| Type 1 diabetes and non-painful neuropathy | – | Diagnostic Test: Perception Threshold Tracking (PTT), Diagnostic Test: Axon-flair mediated respons, Diagnostic Test: Heart rate variability, Diagnostic Test: Quantitative Sensory Testing (QST), Diagnostic Test: Peripheral blood pressure and transcutaneous oxygen tension, Diagnostic Test: Magnetic Resonance Imaging (MRI), Diagnostic Test: Questionnaires, Diagnostic Test: Corneal Confocal Microscopy /CCM)No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied. |
| Type 1 diabetes and no neuropathy | – | Diagnostic Test: Perception Threshold Tracking (PTT), Diagnostic Test: Axon-flair mediated respons, Diagnostic Test: Heart rate variability, Diagnostic Test: Quantitative Sensory Testing (QST), Diagnostic Test: Peripheral blood pressure and transcutaneous oxygen tension, Diagnostic Test: Magnetic Resonance Imaging (MRI), Diagnostic Test: Questionnaires, Diagnostic Test: Corneal Confocal Microscopy /CCM)No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied. |
| Matched controls without diabetes | – | Diagnostic Test: Perception Threshold Tracking (PTT), Diagnostic Test: Axon-flair mediated respons, Diagnostic Test: Heart rate variability, Diagnostic Test: Quantitative Sensory Testing (QST), Diagnostic Test: Peripheral blood pressure and transcutaneous oxygen tension, Diagnostic Test: Magnetic Resonance Imaging (MRI), Diagnostic Test: Questionnaires, Diagnostic Test: Corneal Confocal Microscopy /CCM)No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population include four well-defined groups of subjects: 1. Patients with Type 1 diabetes and painful diabetic peripheral neuropathy (DPN). 2. Patients with Type 1 diabetes and non-painful diabetic peripheral neuropathy (DPN) 3. Patients with Type 1 diabetes and without diabetic peripheral neuropathy (VPT<15) (DPN). 4. Healthy control subjects matched for age, BMI, and gender. Diabetes duration, HbA1c, insulin use, ethnicity, and co-morbidities will be matched between group 1, 2 and 3 to best ability.
Key inclusion criteria (8 listed)
- Men and women minimum 18 years of age and maximum 75 years of age
- Signed informed consent form
- Diagnosed with diabetes type I (for group 1-3)
- Diagnosed with DPN defined as a threshold above 25-volt biothesiometry or absent feeling on the big toe using 10g-monofilament. (for group 1-2)
- Answered questionnaire: PainDETECT
Key exclusion criteria (1 listed)
- 1. Current or previous alcohol- or drug abuse 2. Abnormal screening blood samples 3. Not being able to understand Danish written and/or verbally 4. Not being able to corporate to examination (e.g. not being able to speak, suffering from senile dementia etc.) 5. Previous chemotherapy or intake of experimental medicine 6. Active HSV- or VZV-infection or known HIV 7. Known severe skin disease 8. Known neural damage or disease in the neural system (e.g. MS, Guillain-Barre etc.) 9. Critical limb ischemia defined as in current clinical consensus 10. Allergy or intolerance to histamine or inability to make do without for one day 11. Pregnancy 12. Active cancer-disease
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 |
|---|---|---|
| Perception Threshold Tracking (PTT)low-current electrical stimulation of both large- and small nerve fibers. | Diagnostic test | Matched controls without diabetes, Type 1 diabetes and no neuropathy, Type 1 diabetes and non-painful neuropathy, Type 1 diabetes and painful neuropathy |
| Axon-flair mediated responsAlso: Laser-dopplerLaser-doppler examination of small blood vessels in the peripheral skin. | Diagnostic test | Matched controls without diabetes, Type 1 diabetes and no neuropathy, Type 1 diabetes and non-painful neuropathy, Type 1 diabetes and painful neuropathy |
| Heart rate variabilityAlso: Vagus TM4 measurements of heart rate. | Diagnostic test | Matched controls without diabetes, Type 1 diabetes and no neuropathy, Type 1 diabetes and non-painful neuropathy, Type 1 diabetes and painful neuropathy |
| Quantitative Sensory Testing (QST)Also: German Research Network on Neuropathic Pain (DFNS) standard protocolSeven tests measuring 13 parameters including heat- and cold-detection and pain thresholds, mechanical pain treshold, mechanical detection threshold, pressure pain treshold and vibration threshold. | Diagnostic test | Matched controls without diabetes, Type 1 diabetes and no neuropathy, Type 1 diabetes and non-painful neuropathy, Type 1 diabetes and painful neuropathy |
| Peripheral blood pressure and transcutaneous oxygen tensionAlso: Perimed 6000Ankle/brachial index, toe/brachial index, TcpO2. | Diagnostic test | Matched controls without diabetes, Type 1 diabetes and no neuropathy, Type 1 diabetes and non-painful neuropathy, Type 1 diabetes and painful neuropathy |
| Magnetic Resonance Imaging (MRI)MRI-scans of peripheral nerves and the central nervous system. Blood oxygen level dependent (BOLD) MRI. | Diagnostic test | Matched controls without diabetes, Type 1 diabetes and no neuropathy, Type 1 diabetes and non-painful neuropathy, Type 1 diabetes and painful neuropathy |
| QuestionnairesAlso: PainDETECT, Douleur Neuropathique 4Questionnaires for detecting painful neuropathy | Diagnostic test | Matched controls without diabetes, Type 1 diabetes and no neuropathy, Type 1 diabetes and non-painful neuropathy, Type 1 diabetes and painful neuropathy |
| Corneal Confocal Microscopy /CCM)Confocal microscopy of the cornea measuring NBD, NFD, NFL | Diagnostic test | Matched controls without diabetes, Type 1 diabetes and no neuropathy, Type 1 diabetes and non-painful neuropathy, Type 1 diabetes and painful neuropathy |
Primary outcome
Diagnostic value of CCM, PTT, AF and MRI
Time frame: End of study (when all patients have completed all sessions. Latest 31. december 2021)
Using Quantitative Sensory Testing (small fibers) and conventional nerve conduction studies (large fibers) as golden standards, we will determine the prognostic value of: Perception Threshold Tracking Corneal Confocal Microscopy Axon-flair mediated response MRI-scans in detecting neuropathy. Sensitivity and specificity will be reported. OBS! Tests will be tested in the initial groups and AFTER a group re-arrangement based on results from QST and NCS.
1 secondary outcome
Validation of PainDETECT in diabetes
Time frame: End of study / end of inclusion (when all patients have completed the screening session. Latest 31. november 2021)
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 2 Nov 2021.
- Derived from this study: PubMed 41246983Moussa F, Taleb S, Borbjerg MK, Croosu SS, Morch CD, Frokjaer JB, Hansen TM, Ejskjaer N, Roikjer J. Corneal Immune Cells and Their Relation to Diabetic Peripheral Neuropathy and Neuropathic Pain. Muscle Nerve. 2026 Jan;73(1):72-78. doi: 10.1002/mus.70061. Epub 2025 Nov 17.
- Derived from this study: PubMed 40987057Hostrup SN, Lind HP, Croosu SS, Roikjer J, Morch CD, Ejskjaer N, Ostergaard LR, Hansen TM, Frokjaer JB. Multimodal MRI analysis selecting key brain features for machine learning based classification of diabetic neuropathic pain and phenotypes. J Neurol Sci. 2025 Nov 15;478:123701. doi: 10.1016/j.jns.2025.123701. Epub 2025 Sep 15.
- Derived from this study: PubMed 36825610Roikjer J, Croosu SS, Sejergaard BF, Hansen TM, Frokjaer JB, Sondergaard CB, Petropoulos IN, Malik RA, Nielsen E, Morch CD, Ejskjaer N. Diagnostic Accuracy of Perception Threshold Tracking in the Detection of Small Fiber Damage in Type 1 Diabetes. J Diabetes Sci Technol. 2024 Sep;18(5):1157-1164. doi: 10.1177/19322968231157431. Epub 2023 Feb 24.
- Derived from this study: PubMed 36130086Roikjer J, Croosu SS, Frokjaer JB, Hansen TM, Arendt-Nielsen L, Ejskjaer N, Morch CD. Perception threshold tracking: validating a novel method for assessing function of large and small sensory nerve fibers in diabetic peripheral neuropathy with and without pain. Pain. 2023 Apr 1;164(4):886-894. doi: 10.1097/j.pain.0000000000002780. Epub 2022 Sep 19.
- Individual participant dataSharing planned: Yes. Data will be shared with collaborating department: Department of Radiology with the purpose of analyzing the data and comparing it to their MRI scans. Data will be shared with Aalborg University with the purpose of analyzing data.
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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.
Niels Ejskjær, Professor principal investigator
Steno Diabtes Center North Denmark, Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathy, Diabetic and Neuropathy, Painful, run by Aalborg University Hospital at 1 site in Denmark.
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 1 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 2 Nov 2021. 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 Denmark. 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?
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?
Diagnostic value of CCM, PTT, AF and MRI (time frame: End of study (when all patients have completed all sessions. Latest 31. december 2021)). 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 NCT04078516, which also lists 4 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 2 Nov 2021.