Osteogenesis ImperfectaAVOINCT05419960
Audio-vestibular Evaluation of Children and Young Adults With Osteogenesis Imperfecta
An observational study of Osteogenesis Imperfecta, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim is to determine whether vestibular deficits are present in OI, then to establish whether a correlation exists between genetic type, severity of OI and audiovestibular phenotype. OI patients aged 12 to 20 years will undergo an audiometric, immittance, and vestibular assessment. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Osteogenesis Imperfecta
- What is being tested?
- Vestibular Assessment, Petrous bone Computed Tomography (CT) and Magnetic Resonance Imaging (MRI)
- Type of treatment
- Injection or infusion
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 22 Dec 2022to 22 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents and young adults with a diagnosis of Osteogenesis Imperfecta of any type and followed by a physician at the Centre de Référence des Maladies Rares des maladies osseuses constitutionnelles (CRMR OI) of Hôpital Necker-Enfants malades.
Who may be able to join
- Patients between the ages of 12-20 years at the time of inclusion
- Diagnosis of Osteogenesis Imperfecta of any type
- Currently followed by a physician at the CRMR OI
- Information and non-opposition of major patients, holders of parental authority and minor patients to participate in the study
Who cannot join
- Patients with hearing loss of alternate origin e.g. Cochlear nerve deficiency, atresia, etc.
- Neurological or developmental deficits limiting participation
- Cervico-occipital instability e.g. Chiari's malformation
- Limitations in mobility of the spine e.g. scoliosis, spinal fractural fusion
- Ophthalmologic pathologies e.g. strabism or severe refraction disorder
- Patients under AME (State Medical Aid)
- Protected adult patients, adults unable to express their consent, pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Necker-Enfants Malades
Paris, 75015
Natalie Loundon, MD, PhD, 1 71 39 67 82 ext. +33, natalie.loundon@aphp.fr
Geneviève BAUJAT, MD
About this study
The aim is to determine whether vestibular deficits are present in OI, then to establish whether a correlation exists between genetic type, severity of OI and audiovestibular phenotype. OI patients aged 12 to 20 years will undergo an audiometric, immittance, and vestibular assessment. When hearing loss is conductive or mixed or in cases where vestibular deficits are identified, a CT scan without injection will be performed. In case of sensorineural hearing loss or abnormal CT results, an MRI will be performed.
Read the detailed description
Osteogenesis Imperfecta (OI), or Lobstein's disease, is a form of congenital osteoporosis, with a prevalence between 1/10,000 and 1/20,000 in France. As of 1979, four phenotypes have been described according to severity: moderate (type I), lethal (type II), severe (type III), and moderate-to-severe (type IV). OI exhibits phenotypic and genotypic variability, however, to date no correlations have been established between specific mutations and clinical presentation.
There is a well-established association between OI and hearing loss, however, the reported prevalence of hearing loss varies between 2% to 94.1%.
In patients with OI, Computed Tomography (CT) has revealed bone demineralization that progresses with age.
The extent of the hypodense areas on the CT corresponds to the type of hearing loss: conductive hearing loss is associated with lesions of the fissula ante fenestram and round and oval windows while mixed hearing loss is associated with additional retrofenestral lesions. Severity of hearing loss is positively correlated with OI-related bone damage in the petrous bone. Magnetic Resonance Imaging (MRI) has also revealed in the pericochlear lesions with soft tissue hypersignal and enhancement on contrast medium injection in the otic capsule. Bone demineralization has also been linked to vestibular deficits, and some studies have reported correlations between Osteogenesis Imperfecta and vestibular deficits in adult patients, however, this relationship is less clear.
The aim of the study is to determine whether vestibular deficits are also present in OI. Furthermore, the study will aim to establish whether a correlation exists between genetic type, severity of OI and audiovestibular phenotype. OI patients aged 12 to 20 years will be recruited and an audiometric, immittance, and vestibular assessment (videonystagmography, video Head Impulse Test (vHIT), vestibular evoked muscular potentials (cVEMP)) will be performed during their annual visit to the Centre de Référence des Maladies Rares des maladies osseuses constitutionnelles (henceforth CRMR OI) of Hôpital Necker-Enfants malades, Paris, France. When hearing loss is conductive, or mixed or in cases where vestibular deficits are identified, a CT scan without injection will be performed for the care. In case of sensorineural hearing loss, or abnormal CT results, an MRI will be proposed for the care. The investigation team will try to establish if there is a significant association between OI and vestibular deficit, and if so, whether the degree of vestibular impairment is correlated to radiological findings with respect to bone abnormalities, as well as the type and severity of the deafness.
- Conditions
- Osteogenesis Imperfecta
- Being tested
- Vestibular Assessment, Petrous bone Computed Tomography (CT), Magnetic Resonance Imaging (MRI)
- Keywords
- Osteogenesis imperfecta, Vestibular deficits, Correlation between vestibular impairment and radiological findings, Bone abnormalities, Severity of the deafness
- Medical subject headings
- Osteogenesis Imperfecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular AssessmentDiagnostic test
During the usual hearing assessment (immittance testing and pure-tone and speech audiometry) carried out by patients, a vestibular assessment will be done for the study to detect vestibular disorders:
- Videonystagmography (VNG) Is the study of eye movement with the help of infrared googles.
- Subjective Visual Vertical (SVV) The patient is asked to orient a line on the vertical axis.
- Video Head Impulse Test (vHIT)
- Cervical and Ocular Vestibular Evoked Myogenic Potential (cVEMP and oVEMP)
Petrous bone Computed Tomography (CT)Diagnostic test
For patients diagnosed with hearing loss, whether conductive, mixed, and/or a vestibular deficit, a CT scan (without injection) will be proposed for their care.
Petrous bone Computed Tomography (CT) is an imaging technique used as the standard method of evaluation of the boney structures in the ear.
Magnetic Resonance Imaging (MRI)Diagnostic test
Patients that have done a CT and for who CT results was abnormal, will additionally require an MRI for their standard care.
Magnetic Resonance Imaging (MRI) is an imaging technique used as the standard method of evaluation of the cochlear, retrocochlear and central and peripheral nervous system. An injection of Gadolinium contrast media will be used to enhance certain recordings.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients between the ages of 12-20 years with a diagnosis of Osteogenesis Imperfecta of any type and followed by a physician at the Centre de Référence des Maladies Rares des maladies osseuses constitutionnelles (CRMR OI) of Hôpital Necker-Enfants malades. Receives: Diagnostic Test: Vestibular Assessment; Diagnostic Test: Petrous bone Computed Tomography (CT); Diagnostic Test: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Vestibular Function
Is evaluated by videonystagmography (VNG). The purpose of this test battery is to separate the vestibular disorders from disorders of the central neural system.
Clinical norms will be applied to determine whether the exam is either within normal limits or abnormal.
Research of eventual vestibular disorder to determine if vestibular disorders can be linked to Osteogenesis Imperfecta.
Measured: 24 months
Subjective Visual Vertical (SVV)
Utricular Function Research of eventual vestibular disorder to determine if vestibular disorders can be linked to Osteogenesis Imperfecta.
The patient is asked to orient a line on the vertical axis. An angle of 3 degrees from the vertical indicates an otolithic utricular disorder.
Clinical norms will be applied to determine whether the exam is either within normal limits or abnormal.
Measured: 24 months
Ocular Vestibular Evoked Myogenic Potential (oVEMP)
Utricular Function Research of eventual vestibular disorder to determine if vestibular disorders can be linked to Osteogenesis Imperfecta.
The oVEMP assesses utricular function and reflects the function of the vestibular nuclei and the crossed vestibulo-ocular reflex (VOR) pathways, mostly contained in the medial longitudinal fasciculus (MLF).
Clinical norms will be applied to determine whether the exam is either within normal limits or abnormal.
Measured: 24 months
Semi-circular canal function
Video Head Impulse Test (vHIT). The vHIT assesses the vestibular ocular reflex linked to the semi-circular canal function when stimulated at a high frequency.
Clinical norms will be applied to determine whether the exam is either within normal limits or abnormal.
Research of eventual vestibular disorder to determine if vestibular disorders can be linked to Osteogenesis Imperfecta.
Measured: 24 months
Cervical Vestibular Evoked Myogenic Potential (cVEMP)
Saccular Function Research of eventual vestibular disorder to determine if vestibular disorders can be linked to Osteogenesis Imperfecta.
The cVEMP assesses the saccular function via the saccular cervical reflex (sternocleidomastoid muscle's activation secondary to saccular auditory stimulation).
Clinical norms will be applied to determine whether the exam is either within normal limits or abnormal.
The otolith organs are comprised of the vestibular saccule and utricule. The cVEMP assesses the saccular function via the saccular cervical reflex (sternocleidomastoid muscle's activation secondary to saccular auditory stimulation).
Clinical norms will be applied to determine whether the exam is either within normal limits or abnormal.
Research of eventual vestibular disorder to determine if vestibular disorders can be linked to Osteogenesis Imperfecta.
Measured: 24 months
Secondary outcomes (6)
Immittance testing
Audiological phenotype Immittance testing can indicate whether middle ear structures are in tact
- Middle ear pressure and compliance of the tympanic membrane
- Ipsilateral acoustic reflex thresholds
Measured: 24 months
Pure-tone audiometry
Audiometry performance Pure tone audiometry is used to establish the type and degree of hearing loss. This measure is important to characterize the audiological phenotype. Hearing thresholds established in air and bone conduction between 250-8000Hz in each ear.
Pure tone audiometry assessed as normal or abnormal Audiometry is considered abnormal if any threshold is greater than or equal to 25 dB HL.
Measured: 24 months
Speech Audiometry
Audiometry performance Speech audiometry is used to establish the lowest intensity level in dB at which the patient can comprehend 50% of speech. This measure is important to confirm reliability of the pure tone audiometry, and to confirm that speech is both audible and intelligible.
Speech audiometry assessed as normal or abnormal.
Measured: 24 months
Severity of OI
OI medical diagnosis. The OI diagnosis is clinical, based on the following signs: ligament laxity, bluish discoloration of the sclera, hearing loss, vascular tissue abnormalities, hemostatic disorder, elevated basal metabolic rate, renal disorder, neurological disorder, history family.
Depending on symptom severity, OI patient's diagnosis will be classified into on of four phenotypes : moderate (type I), lethal (type II), severe (type III), and moderate-to-severe (type IV).
Measured: 24 months
Petrous bone Computed Tomography (CT)
CT is used to evaluate the presence and localization of petrous bone anomalies, for patients with conductive or mixed hearing loss and/or vestibular deficits.
Measured: 24 months
Magnetic Resonance Imaging (MRI)
MRI is used to evaluate the presence and characteristics of anomalies of inner ear soft tissues, for patients with sensorineural hearing loss and for patients with abnormal CT scan results.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start22 Dec 2022
- Primary completion22 Dec 2027 (estimated)
- Study completion22 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteogenesis ImperfectaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Natalie Loundon, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisMarine Parodi, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419960
- Sponsor's protocol ID
- APHP220305
- Other IDs
- 2022-A00375-38
- Acronym
- AVOI
- Status last verified
- Sep 2025
- First submitted
- 12 May 2022
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audio-vestibular Evaluation of Children and Young Adults With Osteogenesis Imperfecta
- ClinicalTrials.gov ID
- NCT05419960
- Acronym / sponsor ID
- AVOI / APHP220305
- Conditions
- Osteogenesis Imperfecta
- Keywords
- Osteogenesis imperfecta, Vestibular deficits, Correlation between vestibular impairment and radiological findings, Bone abnormalities, Severity of the deafness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 22 Dec 2027 (estimated)
- Study completion
- 22 Dec 2027 (estimated)
- First posted
- 15 Jun 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 aim is to determine whether vestibular deficits are present in OI, then to establish whether a correlation exists between genetic type, severity of OI and audiovestibular phenotype. OI patients aged 12 to 20 years will undergo an audiometric, immittance, and vestibular assessment. When hearing loss is conductive or mixed or in cases where vestibular deficits are identified, a CT scan without injection will be performed. In case of sensorineural hearing loss or abnormal CT results, an MRI will be performed.
Detailed description
Osteogenesis Imperfecta (OI), or Lobstein's disease, is a form of congenital osteoporosis, with a prevalence between 1/10,000 and 1/20,000 in France. As of 1979, four phenotypes have been described according to severity: moderate (type I), lethal (type II), severe (type III), and moderate-to-severe (type IV). OI exhibits phenotypic and genotypic variability, however, to date no correlations have been established between specific mutations and clinical presentation.
There is a well-established association between OI and hearing loss, however, the reported prevalence of hearing loss varies between 2% to 94.1%.
In patients with OI, Computed Tomography (CT) has revealed bone demineralization that progresses with age.
The extent of the hypodense areas on the CT corresponds to the type of hearing loss: conductive hearing loss is associated with lesions of the fissula ante fenestram and round and oval windows while mixed hearing loss is associated with additional retrofenestral lesions. Severity of hearing loss is positively correlated with OI-related bone damage in the petrous bone. Magnetic Resonance Imaging (MRI) has also revealed in the pericochlear lesions with soft tissue hypersignal and enhancement on contrast medium injection in the otic capsule. Bone demineralization has also been linked to vestibular deficits, and some studies have reported correlations between Osteogenesis Imperfecta and vestibular deficits in adult patients, however, this relationship is less clear.
The aim of the study is to determine whether vestibular deficits are also present in OI. Furthermore, the study will aim to establish whether a correlation exists between genetic type, severity of OI and audiovestibular phenotype. OI patients aged 12 to 20 years will be recruited and an audiometric, immittance, and vestibular assessment (videonystagmography, video Head Impulse Test (vHIT), vestibular evoked muscular potentials (cVEMP)) will be performed during their annual visit to the Centre de Référence des Maladies Rares des maladies osseuses constitutionnelles (henceforth CRMR OI) of Hôpital Necker-Enfants malades, Paris, France. When hearing loss is conductive, or mixed or in cases where vestibular deficits are identified, a CT scan without injection will be performed for the care. In case of sensorineural hearing loss, or abnormal CT results, an MRI will be proposed for the care. The investigation team will try to establish if there is a significant association between OI and vestibular deficit, and if so, whether the degree of vestibular impairment is correlated to radiological findings with respect to bone abnormalities, as well as the type and severity of the deafness.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Vestibular Assessment, Diagnostic Test: Petrous bone Computed Tomography (CT), Diagnostic Test: Magnetic Resonance Imaging (MRI)Patients between the ages of 12-20 years with a diagnosis of Osteogenesis Imperfecta of any type and followed by a physician at the Centre de Référence des Maladies Rares des maladies osseuses constitutionnelles (CRMR OI) of Hôpital Necker-Enfants malades. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents and young adults with a diagnosis of Osteogenesis Imperfecta of any type and followed by a physician at the Centre de Référence des Maladies Rares des maladies osseuses constitutionnelles (CRMR OI) of Hôpital Necker-Enfants malades.
Key inclusion criteria (4 listed)
- Patients between the ages of 12-20 years at the time of inclusion
- Diagnosis of Osteogenesis Imperfecta of any type
- Currently followed by a physician at the CRMR OI
- Information and non-opposition of major patients, holders of parental authority and minor patients to participate in the study
Key exclusion criteria (7 listed)
- Patients with hearing loss of alternate origin e.g. Cochlear nerve deficiency, atresia, etc.
- Neurological or developmental deficits limiting participation
- Cervico-occipital instability e.g. Chiari's malformation
- Limitations in mobility of the spine e.g. scoliosis, spinal fractural fusion
- Ophthalmologic pathologies e.g. strabism or severe refraction disorder
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 |
|---|---|---|
| Vestibular AssessmentDuring the usual hearing assessment (immittance testing and pure-tone and speech audiometry) carried out by patients, a vestibular assessment will be done for the study to detect vestibular disorders: * Videonystagmography (VNG) Is the study of eye movement with the help of infrared googles. * Subjective Visual Vertical (SVV) The patient is asked to orient a line on the vertical axis. * Video Head Impulse Test (vHIT) * Cervical and Ocular Vestibular Evoked Myogenic Potential (cVEMP and oVEMP) | Diagnostic test | Patients |
| Petrous bone Computed Tomography (CT)For patients diagnosed with hearing loss, whether conductive, mixed, and/or a vestibular deficit, a CT scan (without injection) will be proposed for their care. Petrous bone Computed Tomography (CT) is an imaging technique used as the standard method of evaluation of the boney structures in the ear. | Diagnostic test | Patients |
| Magnetic Resonance Imaging (MRI)Patients that have done a CT and for who CT results was abnormal, will additionally require an MRI for their standard care. Magnetic Resonance Imaging (MRI) is an imaging technique used as the standard method of evaluation of the cochlear, retrocochlear and central and peripheral nervous system. An injection of Gadolinium contrast media will be used to enhance certain recordings. | Diagnostic test | Patients |
Primary outcome
Central Vestibular Function
Time frame: 24 months
Is evaluated by videonystagmography (VNG). The purpose of this test battery is to separate the vestibular disorders from disorders of the central neural system. Clinical norms will be applied to determine whether the exam is either within normal limits or abnormal. Research of eventual vestibular disorder to determine if vestibular disorders can be linked to Osteogenesis Imperfecta.
Subjective Visual Vertical (SVV)
Time frame: 24 months
Utricular Function Research of eventual vestibular disorder to determine if vestibular disorders can be linked to Osteogenesis Imperfecta. The patient is asked to orient a line on the vertical axis. An angle of 3 degrees from the vertical indicates an otolithic utricular disorder. Clinical norms will be applied to determine whether the exam is either within normal limits or abnormal.
Ocular Vestibular Evoked Myogenic Potential (oVEMP)
Time frame: 24 months
Utricular Function Research of eventual vestibular disorder to determine if vestibular disorders can be linked to Osteogenesis Imperfecta. The oVEMP assesses utricular function and reflects the function of the vestibular nuclei and the crossed vestibulo-ocular reflex (VOR) pathways, mostly contained in the medial longitudinal fasciculus (MLF). Clinical norms will be applied to determine whether the exam is either within normal limits or abnormal.
Semi-circular canal function
Time frame: 24 months
Video Head Impulse Test (vHIT). The vHIT assesses the vestibular ocular reflex linked to the semi-circular canal function when stimulated at a high frequency. Clinical norms will be applied to determine whether the exam is either within normal limits or abnormal. Research of eventual vestibular disorder to determine if vestibular disorders can be linked to Osteogenesis Imperfecta.
Cervical Vestibular Evoked Myogenic Potential (cVEMP)
Time frame: 24 months
Saccular Function Research of eventual vestibular disorder to determine if vestibular disorders can be linked to Osteogenesis Imperfecta. The cVEMP assesses the saccular function via the saccular cervical reflex (sternocleidomastoid muscle's activation secondary to saccular auditory stimulation). Clinical norms will be applied to determine whether the exam is either within normal limits or abnormal. The otolith organs are comprised of the vestibular saccule and utricule. The cVEMP assesses the saccular function via the saccular cervical reflex (sternocleidomastoid muscle's activation secondary to saccular auditory stimulation). Clinical norms will be applied to determine whether the exam is either within normal limits or abnormal. Research of eventual vestibular disorder to determine if vestibular disorders can be linked to Osteogenesis Imperfecta.
6 secondary outcomes
Immittance testing
Time frame: 24 months
Pure-tone audiometry
Time frame: 24 months
Speech Audiometry
Time frame: 24 months
Severity of OI
Time frame: 24 months
Petrous bone Computed Tomography (CT)
Time frame: 24 months
Magnetic Resonance Imaging (MRI)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- 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.
Natalie Loundon, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Marine Parodi, MD study director
Assistance Publique - Hôpitaux de Paris
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 Osteogenesis Imperfecta, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 12 Sep 2025. 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 France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalie Loundon, MD, PhD (1 71 39 67 82 ext. +33, natalie.loundon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Vestibular Function (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2025.