Guillain-Barre SyndromeNCT06300359
Prognostic Indicators of Gullian-Barre Syndrome
An observational study of Guillain-Barre Syndrome, run by Assiut University.
Trial summary
Prognostic indicators of Gullian-Barre syndrome and the predictive factors associated with worse prognosis in the Guillain-Barré syndrome (GBS), which can be helpful to fully evaluate the disease progression and provide proper treatments. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Guillain-Barre Syndrome
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Jun 2025
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children with GBS, presenting with weakness, diagnosed on clinical and/or electrophysiological grounds, were enrolled. The enrolled children underwent a detailed clinical-assessment followed by nerve conduction studies.
Who may be able to join
- Patients 2 - 18 years old with guillian barrie syndrome admitted at Assiut university children hospital.
- Acceptance to participate in this study .
Who cannot join
- Patients aged less than 2 years and more than 18 years old . Children or Parents who refused to participate in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prognostic Indicators of Gullian-Barre Syndrome at Assiut University Children Hospital
Prognostic indicators of Gullian-Barre syndrome and the predictive factors associated with worse prognosis in the Guillain-Barré syndrome (GBS), which can be helpful to fully evaluate the disease progression and provide proper treatments.
Read the detailed description
Guillain Barre Syndrome (GBS) is an autoimmune disorder with post-infectious polyneuropathy involving motor, sensory and sometimes the autonomic nerves. With the eradication of wild polio virus infection, GBS has become the most common cause of acute flaccid paralysis in both the developed and developing countries.GBS occurs throughout the world with a median annual incidence of 1.3 cases per population of 100 000.
GBS is characterized by ascending paralysis (lower limb numbness, paraesthesia or pain followed by weakness which ascends symmetrically and gradually progresses over a period of 1 to 28 days with maximum severity of weakness by four weeks after the onset). Bulbar involvement is seen in 50% cases and autonomic disturbances are seen in about 20%. Since there may be mortality related to acute complications of respiratory muscle paralysis and morbidity related to the long duration of the paralysis.
It can be classified electrophysiologically into demyelinating and axonal subtypes. Acute inflammatory demyelinating polyneuropathy (AIDP) is the demyelinating subtype, while acute motor axonal (AMAN) and acute motor-sensory axonal neuropathy (AMSAN) are the axonal subtypes. It is difficult to differentiate between them clinically and nerve conduction studies (NCS) can play an important role. Determining the electrophysiological subtype is useful as it can give insights into the underlying pathophysiology. This has both therapeutic and prognostic significance. Various electrodiagnostic criteria sets have been proposed to differentiate between the demyelinating and axonal subtypes.
GBS typically occurs after an infectious disease (Two-thirds of patients report symptoms of a respiratory or gastrointestinal tract infection before the onset of GBS. In about half of patients with GBS, a specific type of preceding infection can be identified and Campylobacter jejuni is responsible for at least one-third of these infections. Other pathogens that cause antecedent infections related to GBS are cytomegalovirus, Epstein- Barr virus, Mycoplasma pneumonia, Haemophilus influenzae, and influenza A virus) in which the immune response generates antibodies that crossreact with gangliosides at nerve membranes. This autoimmune response results in nerve damage or functional blockade of nerve conduction. The type of preceding infection and the specificity of the antiganglioside antibodies largely determine the subtype and clinical course of GBS.
The chance of recovery was significantly affected by age, antecedent gastroenteritis, disability, electrophysiological signs of axonopathy, latency to nadir and duration of active disease.The main treatments did not seem to affect the chance of recovery.
Acute motor axon neuropathy, diabetes, high blood pressure, uroschesis, high body temperature, ventilator support,consciousness disorder, absence of upper respiratory tract preceding infection, hyperglycemia, hyponatremia,hypoalbuminemia, high leukocyte count, hyperfibrinogenemia, abnormal hepatic and renal function were demonstrated as poor prognostic factors.
Dysautonomic syndrome, cardiac arrest and respiratory failure were the leading causes of death.
Paralysis of respiratory muscles is a dreaded complication that occurs in one-fourth of the subjects. Respiratory weakness occurs due to the involvement of both inspiratory and expiratory muscles. Diaphragmatic weakness occurs due to phrenic nerve demyelination. Careful and close monitoring is mandatory to identify patients at high risk for respiratory failure, and triage them to the Intensive Care Unit (ICU) and mechanical ventilation.
The diagnosis was based mostly on clinical judgement and was confirmed by autopsy only in a few instances. In the presence of suggestive findings the complementary test as demyelinising changes in the nerve conduction studies (NCS) or albuminocytological dissociation in the cerebrospinal fluid (CSF), help to confirm the diagnosis.
- Consider specific treatment with IVIg or PE:
- IVIg is usually the first- line therapy for children with GBS. Although some paediatric centres administer IVIg as 2 g/kg (body weight) over 2 days, rather than the standard adult regimen of 2 g/kg (body weight) over 5 days.
- plasma exchange can be difficult to perform in young children, and care should be taken in patients with autonomic cardiovascular instability because of the large volume shifts involved in the plasma exchange procedure.
- Indications to start IVIg or PE: Severely affected patients (inability to walk unaided, GBS disability scale ≥3). Unknown whether IVIg is effective: Mildly affected patients (GBS disability scale ≤2) or MFS patients .
- Indications for re-treatment with IVIg:
- Secondary deterioration after initial improvement or stabilisation (treatment-related fluctuation): treat with 0·4 g/kg for 5 days.
- No proven effect of re-treatment with IVIg in patients who continue to worsen.
- Steroids :
Oral steroids or intravenous methylprednisolone (500 mg daily for 5 consecutive days) alone are not beneficial in GBS. The combination of IVIg and intravenous methylprednisolone was not more effective than IVIg alone.
-Give good general care: Monitor progression and prevent and manage potentially fatal complications.
- Indication for admission to an intensive care unit:
- Rapid progressive severe weakness often with impaired respiration (vital capacity <20 mL/kg).
- Need for artifi cial ventilation Insufficient.
- swallowing with high chance of pulmonary infection.
- Severe autonomic dysfunction.
- Physiotherapy and Rehabilitation.
- Conditions
- Guillain-Barre Syndrome
- Keywords
- Prognostic indicators
- Medical subject headings
- Guillain-Barre Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic indicators of Gullian-Barre syndrome
The predictive factors with worse prognosis
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Guillain-Barre SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Abdelhakem Sayed Amin, Assiut University
- Investigators
- Amira A Sayed Amin, Resident, Principal investigator, Assiut UniversityGamal A Abdelaal Asker, Professor, Study director, Assiut UniversityAzhar A Mohammed Mohammed, Lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300359
- Sponsor's protocol ID
- Prognostic indicators of GBS
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van den Berg B, Walgaard C, Drenthen J, Fokke C, Jacobs BC, van Doorn PA. Guillain-Barre syndrome: pathogenesis, diagnosis, treatment and prognosis. Nat Rev Neurol. 2014 Aug;10(8):469-82. doi: 10.1038/nrneurol.2014.121. Epub 2014 Jul 15.
PubMed 25023340The prognosis and main prognostic indicators of Guillain-Barre syndrome. A multicentre prospective study of 297 patients. The Italian Guillain-Barre Study Group. Brain. 1996 Dec;119 ( Pt 6):2053-61.
PubMed 9010009van Doorn PA, Ruts L, Jacobs BC. Clinical features, pathogenesis, and treatment of Guillain-Barre syndrome. Lancet Neurol. 2008 Oct;7(10):939-50. doi: 10.1016/S1474-4422(08)70215-1.
PubMed 18848313Gonzalez-Suarez I, Sanz-Gallego I, Rodriguez de Rivera FJ, Arpa J. Guillain-Barre syndrome: natural history and prognostic factors: a retrospective review of 106 cases. BMC Neurol. 2013 Jul 22;13:95. doi: 10.1186/1471-2377-13-95.
PubMed 23876199Kuwabara S. Guillain-Barre syndrome: epidemiology, pathophysiology and management. Drugs. 2004;64(6):597-610. doi: 10.2165/00003495-200464060-00003.
PubMed 15018590Leonhard SE, Mandarakas MR, Gondim FAA, Bateman K, Ferreira MLB, Cornblath DR, van Doorn PA, Dourado ME, Hughes RAC, Islam B, Kusunoki S, Pardo CA, Reisin R, Sejvar JJ, Shahrizaila N, Soares C, Umapathi T, Wang Y, Yiu EM, Willison HJ, Jacobs BC. Diagnosis and management of Guillain-Barre syndrome in ten steps. Nat Rev Neurol. 2019 Nov;15(11):671-683. doi: 10.1038/s41582-019-0250-9. Epub 2019 Sep 20.
PubMed 31541214Mani AM, Prabhakar AT, Alexander PT, Nair A, Vijayaraghavan A, Shaikh A, Benjamin R, Sivadasan A, Mathew V, Aaron S, Alexander M. Utility of Serial Nerve Conduction Studies in the Electrodiagnosis of Guillain-Barre Syndrome. Neurol India. 2021 Mar-Apr;69(2):369-375. doi: 10.4103/0028-3886.314529.
PubMed 33904455Nagappa M, Netto AB, Taly AB, Kulkarni GB, Umamaheshwara Rao GS, Periyavan S, Rao S. Electrophysiological observations in critically ill Guillain-Barre syndrome. Neurol India. 2016 Sep-Oct;64(5):914-20. doi: 10.4103/0028-3886.190271.
PubMed 27625229Rangan RS, Tullu MS, Deshmukh CT, Mondkar SA, Agrawal M. Clinical Profile and Outcome of Guillain-Barre Syndrome in Pediatric Patients Admitted to a Tertiary Care Centre: A Retrospective Study. Neurol India. 2021 Jan-Feb;69(1):81-84. doi: 10.4103/0028-3886.310112.
PubMed 33642275Zhang Y, Zhao Y, Wang Y. Prognostic factors of Guillain-Barre syndrome: a 111-case retrospective review. Chin Neurosurg J. 2018 Jun 18;4:14. doi: 10.1186/s41016-018-0122-y. eCollection 2018.
PubMed 32922875Kleyweg RP, van der Meche FG, Schmitz PI. Interobserver agreement in the assessment of muscle strength and functional abilities in Guillain-Barre syndrome. Muscle Nerve. 1991 Nov;14(11):1103-9. doi: 10.1002/mus.880141111.
PubMed 1745285Fleiss JL, Tytun A, Ury HK. A simple approximation for calculating sample sizes for comparing independent proportions. Biometrics. 1980 Jun;36(2):343-6.
PubMed 26625475
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Indicators of Gullian-Barre Syndrome at Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT06300359
- Acronym / sponsor ID
- Prognostic indicators of GBS
- Conditions
- Guillain-Barre Syndrome
- Keywords
- Prognostic indicators
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 8 Mar 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.
Prognostic indicators of Gullian-Barre syndrome and the predictive factors associated with worse prognosis in the Guillain-Barré syndrome (GBS), which can be helpful to fully evaluate the disease progression and provide proper treatments.
Detailed description
Guillain Barre Syndrome (GBS) is an autoimmune disorder with post-infectious polyneuropathy involving motor, sensory and sometimes the autonomic nerves. With the eradication of wild polio virus infection, GBS has become the most common cause of acute flaccid paralysis in both the developed and developing countries.GBS occurs throughout the world with a median annual incidence of 1.3 cases per population of 100 000.
GBS is characterized by ascending paralysis (lower limb numbness, paraesthesia or pain followed by weakness which ascends symmetrically and gradually progresses over a period of 1 to 28 days with maximum severity of weakness by four weeks after the onset). Bulbar involvement is seen in 50% cases and autonomic disturbances are seen in about 20%. Since there may be mortality related to acute complications of respiratory muscle paralysis and morbidity related to the long duration of the paralysis.
It can be classified electrophysiologically into demyelinating and axonal subtypes. Acute inflammatory demyelinating polyneuropathy (AIDP) is the demyelinating subtype, while acute motor axonal (AMAN) and acute motor-sensory axonal neuropathy (AMSAN) are the axonal subtypes. It is difficult to differentiate between them clinically and nerve conduction studies (NCS) can play an important role. Determining the electrophysiological subtype is useful as it can give insights into the underlying pathophysiology. This has both therapeutic and prognostic significance. Various electrodiagnostic criteria sets have been proposed to differentiate between the demyelinating and axonal subtypes.
GBS typically occurs after an infectious disease (Two-thirds of patients report symptoms of a respiratory or gastrointestinal tract infection before the onset of GBS. In about half of patients with GBS, a specific type of preceding infection can be identified and Campylobacter jejuni is responsible for at least one-third of these infections. Other pathogens that cause antecedent infections related to GBS are cytomegalovirus, Epstein- Barr virus, Mycoplasma pneumonia, Haemophilus influenzae, and influenza A virus) in which the immune response generates antibodies that crossreact with gangliosides at nerve membranes. This autoimmune response results in nerve damage or functional blockade of nerve conduction. The type of preceding infection and the specificity of the antiganglioside antibodies largely determine the subtype and clinical course of GBS.
The chance of recovery was significantly affected by age, antecedent gastroenteritis, disability, electrophysiological signs of axonopathy, latency to nadir and duration of active disease.The main treatments did not seem to affect the chance of recovery.
Acute motor axon neuropathy, diabetes, high blood pressure, uroschesis, high body temperature, ventilator support,consciousness disorder, absence of upper respiratory tract preceding infection, hyperglycemia, hyponatremia,hypoalbuminemia, high leukocyte count, hyperfibrinogenemia, abnormal hepatic and renal function were demonstrated as poor prognostic factors.
Dysautonomic syndrome, cardiac arrest and respiratory failure were the leading causes of death.
Paralysis of respiratory muscles is a dreaded complication that occurs in one-fourth of the subjects. Respiratory weakness occurs due to the involvement of both inspiratory and expiratory muscles. Diaphragmatic weakness occurs due to phrenic nerve demyelination. Careful and close monitoring is mandatory to identify patients at high risk for respiratory failure, and triage them to the Intensive Care Unit (ICU) and mechanical ventilation.
The diagnosis was based mostly on clinical judgement and was confirmed by autopsy only in a few instances. In the presence of suggestive findings the complementary test as demyelinising changes in the nerve conduction studies (NCS) or albuminocytological dissociation in the cerebrospinal fluid (CSF), help to confirm the diagnosis.
- Consider specific treatment with IVIg or PE:
- IVIg is usually the first- line therapy for children with GBS. Although some paediatric centres administer IVIg as 2 g/kg (body weight) over 2 days, rather than the standard adult regimen of 2 g/kg (body weight) over 5 days.
- plasma exchange can be difficult to perform in young children, and care should be taken in patients with autonomic cardiovascular instability because of the large volume shifts involved in the plasma exchange procedure.
- Indications to start IVIg or PE: Severely affected patients (inability to walk unaided, GBS disability scale ≥3). Unknown whether IVIg is effective: Mildly affected patients (GBS disability scale ≤2) or MFS patients .
- Indications for re-treatment with IVIg:
- Secondary deterioration after initial improvement or stabilisation (treatment-related fluctuation): treat with 0·4 g/kg for 5 days.
- No proven effect of re-treatment with IVIg in patients who continue to worsen.
- Steroids :
Oral steroids or intravenous methylprednisolone (500 mg daily for 5 consecutive days) alone are not beneficial in GBS. The combination of IVIg and intravenous methylprednisolone was not more effective than IVIg alone.
-Give good general care: Monitor progression and prevent and manage potentially fatal complications.
- Indication for admission to an intensive care unit:
- Rapid progressive severe weakness often with impaired respiration (vital capacity <20 mL/kg).
- Need for artifi cial ventilation Insufficient.
- swallowing with high chance of pulmonary infection.
- Severe autonomic dysfunction.
- Physiotherapy and Rehabilitation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children with GBS, presenting with weakness, diagnosed on clinical and/or electrophysiological grounds, were enrolled. The enrolled children underwent a detailed clinical-assessment followed by nerve conduction studies.
Key inclusion criteria (2 listed)
- Patients 2 - 18 years old with guillian barrie syndrome admitted at Assiut university children hospital.
- Acceptance to participate in this study .
Key exclusion criteria (1 listed)
- Patients aged less than 2 years and more than 18 years old . Children or Parents who refused to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prognostic indicators of Gullian-Barre syndrome
Time frame: Baseline
The predictive factors with worse prognosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 25023340van den Berg B, Walgaard C, Drenthen J, Fokke C, Jacobs BC, van Doorn PA. Guillain-Barre syndrome: pathogenesis, diagnosis, treatment and prognosis. Nat Rev Neurol. 2014 Aug;10(8):469-82. doi: 10.1038/nrneurol.2014.121. Epub 2014 Jul 15.
- Background: PubMed 9010009The prognosis and main prognostic indicators of Guillain-Barre syndrome. A multicentre prospective study of 297 patients. The Italian Guillain-Barre Study Group. Brain. 1996 Dec;119 ( Pt 6):2053-61.
- Background: PubMed 18848313van Doorn PA, Ruts L, Jacobs BC. Clinical features, pathogenesis, and treatment of Guillain-Barre syndrome. Lancet Neurol. 2008 Oct;7(10):939-50. doi: 10.1016/S1474-4422(08)70215-1.
- Background: PubMed 23876199Gonzalez-Suarez I, Sanz-Gallego I, Rodriguez de Rivera FJ, Arpa J. Guillain-Barre syndrome: natural history and prognostic factors: a retrospective review of 106 cases. BMC Neurol. 2013 Jul 22;13:95. doi: 10.1186/1471-2377-13-95.
- Background: PubMed 15018590Kuwabara S. Guillain-Barre syndrome: epidemiology, pathophysiology and management. Drugs. 2004;64(6):597-610. doi: 10.2165/00003495-200464060-00003.
- Background: PubMed 31541214Leonhard SE, Mandarakas MR, Gondim FAA, Bateman K, Ferreira MLB, Cornblath DR, van Doorn PA, Dourado ME, Hughes RAC, Islam B, Kusunoki S, Pardo CA, Reisin R, Sejvar JJ, Shahrizaila N, Soares C, Umapathi T, Wang Y, Yiu EM, Willison HJ, Jacobs BC. Diagnosis and management of Guillain-Barre syndrome in ten steps. Nat Rev Neurol. 2019 Nov;15(11):671-683. doi: 10.1038/s41582-019-0250-9. Epub 2019 Sep 20.
- Background: PubMed 33904455Mani AM, Prabhakar AT, Alexander PT, Nair A, Vijayaraghavan A, Shaikh A, Benjamin R, Sivadasan A, Mathew V, Aaron S, Alexander M. Utility of Serial Nerve Conduction Studies in the Electrodiagnosis of Guillain-Barre Syndrome. Neurol India. 2021 Mar-Apr;69(2):369-375. doi: 10.4103/0028-3886.314529.
- Background: PubMed 27625229Nagappa M, Netto AB, Taly AB, Kulkarni GB, Umamaheshwara Rao GS, Periyavan S, Rao S. Electrophysiological observations in critically ill Guillain-Barre syndrome. Neurol India. 2016 Sep-Oct;64(5):914-20. doi: 10.4103/0028-3886.190271.
- Background: PubMed 33642275Rangan RS, Tullu MS, Deshmukh CT, Mondkar SA, Agrawal M. Clinical Profile and Outcome of Guillain-Barre Syndrome in Pediatric Patients Admitted to a Tertiary Care Centre: A Retrospective Study. Neurol India. 2021 Jan-Feb;69(1):81-84. doi: 10.4103/0028-3886.310112.
- Background: PubMed 32922875Zhang Y, Zhao Y, Wang Y. Prognostic factors of Guillain-Barre syndrome: a 111-case retrospective review. Chin Neurosurg J. 2018 Jun 18;4:14. doi: 10.1186/s41016-018-0122-y. eCollection 2018.
- Background: PubMed 1745285Kleyweg RP, van der Meche FG, Schmitz PI. Interobserver agreement in the assessment of muscle strength and functional abilities in Guillain-Barre syndrome. Muscle Nerve. 1991 Nov;14(11):1103-9. doi: 10.1002/mus.880141111.
- Background: PubMed 26625475Fleiss JL, Tytun A, Ury HK. A simple approximation for calculating sample sizes for comparing independent proportions. Biometrics. 1980 Jun;36(2):343-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amira A Sayed Amin, Resident principal investigator
Assiut University
Gamal A Abdelaal Asker, Professor study director
Assiut University
Azhar A Mohammed Mohammed, Lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Guillain-Barre Syndrome, run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira A Sayed, Resident (+201118695191, amira.abdelhakem97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic indicators of Gullian-Barre syndrome (time frame: Baseline). 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 NCT06300359, which also lists 12 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 15 Mar 2024.