Multiple Sclerosis-Relapsing-RemittingNCT06381297
Speech in Noise Discrimination Skills in Multiple Sclerosis Patients.
A study testing Hearing test, Speech in noise discrimination test and Montreal Cognitive Assessment Scale in people with Multiple Sclerosis-Relapsing-Remitting, run by Asuman Kucukoner at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical trial was to determine the effect of multiple sclerosis on speech reception and discrimination in noise and to compare the effects on the medial olivocochlear reflex, which is thought to affect speech intelligibility in noise, with a control group. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis-Relapsing-Remitting
- What is being tested?
- Hearing test, Speech in noise discrimination test and Montreal Cognitive Assessment Scale
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Oct 2020to 23 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of Relapsing-remitting MS The absence of other neurological, psychiatric or metabolic diseases besides MS.
Who cannot join
- Exclusion criteria for this group included patients with exacerbation and/or steroid treatment in the last three months, as well as those with a history smoking, alcohol or sedative drug use, unstable vital signs, pregnancy, and serious health problems such as heart or kidney failure, major depression, severe anemia, immunodeficiency, narcolepsy, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Medial Olivocochlear Efferents On Speech Discrimination In Noise In Multiple Sclerosis.
The aim of this clinical trial was to determine the effect of multiple sclerosis on speech reception and discrimination in noise and to compare the effects on the medial olivocochlear reflex, which is thought to affect speech intelligibility in noise, with a control group.
The main questions it aims to answer are:
Does MS disease affect the ability to discriminate speech in noise? Does MS affect contralateral suppression results assessing medial olivocochlear function? Is there a correlation between the ability to discriminate speech in noise and contralateral suppression skills of MS patients? Data from MS patients and healthy participants will be compared. Thirty relapsing remitting MS patients and 30 healthy participants admitted to the clinic will be evaluated.
Read the detailed description
The second aim was to evaluate the relationship between speech comprehension and discrimination skills in noise and cognitive function and to compare them with the control group.
Inclusion Criteria for the Study Group
- Being diagnosed with MS (Primary Progressive, Secondary Progressive, Relapsing Remittting) - exclusion criteria for the control group
- Being between 18-50 years old
- Volunteering
- Co-operation with the scales and tests to be applied
- Normal ENT otoscopic (external and middle ear) examination findings
- Having a normal (type A) tympanogram with a peak value of ± 50 daPa on acoustic impedancemetry examination
- Pure voice average within normal limits (Clark, 1981).
- Speech scores within normal limits (Jerger \& Hayes, 1977).
- No other neurological, psychiatric, metabolic diseases other than MS
- No history of noise exposure and ototoxic drug use Exclusion Criteria for Volunteers
- Not diagnosed with MS (Primary Progressive, Secondary Progressive, Relapsing Remittting) - inclusion criteria for the control group 2) Being younger than 18 years old and older than 50 years old 3) Not wanting to participate in the study or giving up participation 4) Inability to cooperate with the scales and tests to be applied 5) Detection of pathology in ENT otoscopic (external and middle ear) examination findings 6) Obtaining Type B and Type C tympanograms 7) Hearing loss 8) Speech scores are not normal 9) Having any neurological, psychiatric, metabolic disease - MS diagnosis is the inclusion criterion for the study group 10) History of noise exposure and ototoxic drug use The primary endpoint of the study will be to evaluate whether there is a relationship between the MOC reflex and the thresholds for speech reception and discrimination in noise in individuals diagnosed with MS.
It will be evaluated whether cognitive function differences in individuals diagnosed with MS show differences in speech in noise and discrimination thresholds.
- Conditions
- Multiple Sclerosis-Relapsing-Remitting
- Being tested
- Hearing test, Speech in noise discrimination test, Montreal Cognitive Assessment Scale, Symbol Number Modalities Test (SDMT)
- Keywords
- Multıple sclerosis,, Auditory efferent system, Contralateral supression, speech in noise discrimination
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing testDiagnostic test
Also called Contralateral supression test
Hearing and speech tests of MS group and control group in the presence and absence of noise will be evaluated. Suppression test will be performed with OAE test in the presence and absence of noise.
Speech in noise discrimination testDiagnostic test
Speech discrimination in noise (SDN) test will be performed in a quiet room in accordance with the Industrial Acoustic Company (IAC) standard using the Grason-Stadler GSI 61 Clinical Audiometer. After pure tone audiometry and speech tests, the GKAE test will be performed. The speech in noise discrimination test will be performed with a signal-to-noise (S/N) ratio of +10 dB. A word list at 50 dB SL will be presented to the tested ear using live sound, while simultaneously white noise at 40 dB SL will be presented to the test ear (Beattie et al. 1997). This will be done for both ears. The speech in noise discrimination test scores will be calculated as percentages (%) for both ears.
Montreal Cognitive Assessment ScaleDiagnostic test
Translated into Turkish as the Montreal Cognitive Assessment Scale and abbreviated as MOBID, MOCA assesses attention, executive/managerial functions, memory, visual-spatial skills, language, abstract thinking and arithmetic. It is easy and practical to apply. The score that can be obtained varies between 0-30. The cut-off point for cognitive impairment is 21. Patients who perform below 21 points are considered to have cognitive impairment. Although it is not a battery used in the MS patient group, a study conducted on 39 MS patients and 20 healthy people showed that it can be used safely for screening purposes in patients with MS (Aksoy et al., 2013; Nasreddine et al., 2005; Selekler \& Cangoz, 2009).
Symbol Number Modalities Test (SDMT)Diagnostic test
Attention, visuospatial information processing speed and working memory are assessed. It is one of the subtests of the Short Repeatable Neuropsychological Battery developed to assess cognitive functions in MS (Smith, 1973).
| Study group | Role | What they receive |
|---|---|---|
| MS group | Active comparator | Study group (MS patients) Receives: Diagnostic Test: Hearing test; Diagnostic Test: Speech in noise discrimination test; Diagnostic Test: Montreal Cognitive Assessment Scale; Diagnostic Test: Symbol Number Modalities Test (SDMT) |
| Control group | Placebo comparator | Control group ( Healty individuals) Receives: Diagnostic Test: Hearing test; Diagnostic Test: Speech in noise discrimination test; Diagnostic Test: Montreal Cognitive Assessment Scale; Diagnostic Test: Symbol Number Modalities Test (SDMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pure tone Audiometry Test
Air and bone conduction hearing thresholds will be measured using a Grason-Stadler GSI 61 Clinical Audiometer in a quiet room of the Industrial Acoustic Company (IAC) Inc. standard. Airway hearing thresholds will be measured using Telephonics TDH 39 headphones and bone conduction hearing thresholds will be measured using Radioear B-71 bone vibrator. Airway hearing thresholds will be evaluated at frequencies of 0.25 -8 kHz and bone conduction hearing thresholds at 0.5-4 kHz. As pure tone average, 500-1000-2000 Hz air and bone conduction thresholds will be calculated separately for both ears. A pure tone average between 0-15 dB will be considered normal hearing.
Measured: six month
Speech Audiometry
Speech Audiometry will be performed in a quiet room to IAC (Industrial Acoustic Company) standards using a Grason-Stadler GSI 61 Clinical Audiometer.
Speech reception threshold will be determined using three syllable word lists. A 40 dB Sensation Level (SL) will be added above the speech reception threshold and the patient will be asked if he/she can hear comfortably. After determining the level at which the patient can hear most comfortably, 25-word monosyllabic isophonic word lists will be read and the speech discrimination score will be calculated as a percentage. Individuals with a speech discrimination score of 88% and above and with an agreement between speech reception threshold and pure tone averages (SSO) will be included in the study.
Measured: six month
Speech Discrimination in Noise Test
The SDN test will be performed in a quiet room in accordance with the Industrial Acoustic Company (IAC) standard using the Grason-Stadler GSI 61 Clinical Audiometer. After pure tone audiometry and speech tests, the GKAE test will be performed. The speech in noise discrimination test will be performed with a signal-to-noise (S/N) ratio of +10 dB. A word list at 50 dB SL will be presented to the tested ear using live sound, while simultaneously white noise at 40 dB SL will be presented to the test ear (Beattie et al. 1997). This will be done for both ears. The speech in noise discrimination test scores will be calculated as percentages (%) for both ears.
Measured: Six month
Otoacoustic Emission Test
TEOAE measurements of all individuals in the study and control groups will be performed using the computer-based Otodynamics ILO-V6 'cochlear emission analyzer' and software version 5.61 (Otodynamics, London). Adult TEOAE probe will be used for all OAE measurements. The probe will be calibrated in a 1 cc acoustic calibration cavity. The measurement will be performed by averaging the nonlinear, 80 µsec, 260 click stimulus response at 80 ± 3 dB SPL. "Noise rejection level of 47 dB, wave reproducibility of 70% or more, and stimulus stability greater than 80% will be taken into consideration.
Measured: Six month
Contralateral Suppression Test
For TEOAE and contralateral suppression measurements, 60 dB SL white noise will be applied from the opposite ear using a TEOAE probe and emission amplitudes will be measured from the same side ear. All OAE measurements will be performed by inserting the probe once and TEOAE and contralateral suppression tests will be performed respectively. Amplitude (dB) values obtained with suppression at 1000, 1414, 2000, 2828 and 4000 Hz will be used as study parameters.
Measured: Six month
Secondary outcomes (2)
Montreal Cognitive Assessment Scale
Translated into Turkish as the Montreal Cognitive Assessment Scale and abbreviated as MOBID, MOCA assesses attention, executive/managerial functions, memory, visual-spatial skills, language, abstract thinking and arithmetic. It is easy and practical to apply. The score that can be obtained varies between 0-30. The cut-off point for cognitive impairment is 21. Patients who perform below 21 points are considered to have cognitive impairment. Although it is not a battery used in the MS patient group, a study conducted on 39 MS patients and 20 healthy people showed that it can be used safely for screening purposes in patients with MS (Aksoy et al., 2013; Nasreddine et al., 2005; Selekler \& Cangoz, 2009).
Measured: Six Month
Symbol Digit Modalities Test
Attention, visuospatial information processing speed and working memory are assessed. It is one of the subtests of the Short Repeatable Neuropsychological Battery developed to assess cognitive functions in MS (Smith, 1973).
Measured: Six Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start9 Oct 2020
- Primary completion23 Mar 2023
- Study completion23 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis-Relapsing-RemittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Multiple sclerosis patient group and healthy control group.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asuman Kucukoner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asuman Kucukoner, Ondokuz Mayıs University
- Investigators
- ASUMAN KÜÇÜKÖNER, Dr., Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381297
- Sponsor's protocol ID
- OndokusMU
- Other IDs
- Ondokuz Mayıs University
- Status last verified
- Apr 2024
- First submitted
- 1 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be published as a research article.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Medial Olivocochlear Efferents On Speech Discrimination In Noise In Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT06381297
- Acronym / sponsor ID
- OndokusMU
- Conditions
- Multiple Sclerosis-Relapsing-Remitting
- Keywords
- Multıple sclerosis,, Auditory efferent system, Contralateral supression, speech in noise discrimination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Asuman KucukonerUniversity, hospital or other
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Apr 2023 (actual)
- First posted
- 24 Apr 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.
The aim of this clinical trial was to determine the effect of multiple sclerosis on speech reception and discrimination in noise and to compare the effects on the medial olivocochlear reflex, which is thought to affect speech intelligibility in noise, with a control group.
The main questions it aims to answer are:
Does MS disease affect the ability to discriminate speech in noise? Does MS affect contralateral suppression results assessing medial olivocochlear function? Is there a correlation between the ability to discriminate speech in noise and contralateral suppression skills of MS patients? Data from MS patients and healthy participants will be compared. Thirty relapsing remitting MS patients and 30 healthy participants admitted to the clinic will be evaluated.
Detailed description
The second aim was to evaluate the relationship between speech comprehension and discrimination skills in noise and cognitive function and to compare them with the control group.
Inclusion Criteria for the Study Group
- Being diagnosed with MS (Primary Progressive, Secondary Progressive, Relapsing Remittting) - exclusion criteria for the control group
- Being between 18-50 years old
- Volunteering
- Co-operation with the scales and tests to be applied
- Normal ENT otoscopic (external and middle ear) examination findings
- Having a normal (type A) tympanogram with a peak value of ± 50 daPa on acoustic impedancemetry examination
- Pure voice average within normal limits (Clark, 1981).
- Speech scores within normal limits (Jerger \& Hayes, 1977).
- No other neurological, psychiatric, metabolic diseases other than MS
- No history of noise exposure and ototoxic drug use Exclusion Criteria for Volunteers
- Not diagnosed with MS (Primary Progressive, Secondary Progressive, Relapsing Remittting) - inclusion criteria for the control group 2) Being younger than 18 years old and older than 50 years old 3) Not wanting to participate in the study or giving up participation 4) Inability to cooperate with the scales and tests to be applied 5) Detection of pathology in ENT otoscopic (external and middle ear) examination findings 6) Obtaining Type B and Type C tympanograms 7) Hearing loss 8) Speech scores are not normal 9) Having any neurological, psychiatric, metabolic disease - MS diagnosis is the inclusion criterion for the study group 10) History of noise exposure and ototoxic drug use The primary endpoint of the study will be to evaluate whether there is a relationship between the MOC reflex and the thresholds for speech reception and discrimination in noise in individuals diagnosed with MS.
It will be evaluated whether cognitive function differences in individuals diagnosed with MS show differences in speech in noise and discrimination thresholds.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multiple sclerosis patient group and healthy control group.
| Arm | Type | Receives |
|---|---|---|
| MS group | Active comparator | Diagnostic Test: Hearing test, Diagnostic Test: Speech in noise discrimination test, Diagnostic Test: Montreal Cognitive Assessment Scale, Diagnostic Test: Symbol Number Modalities Test (SDMT)Study group (MS patients) |
| Control group | Placebo comparator | Diagnostic Test: Hearing test, Diagnostic Test: Speech in noise discrimination test, Diagnostic Test: Montreal Cognitive Assessment Scale, Diagnostic Test: Symbol Number Modalities Test (SDMT)Control group ( Healty individuals) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Relapsing-remitting MS The absence of other neurological, psychiatric or metabolic diseases besides MS.
Key exclusion criteria (1 listed)
- Exclusion criteria for this group included patients with exacerbation and/or steroid treatment in the last three months, as well as those with a history smoking, alcohol or sedative drug use, unstable vital signs, pregnancy, and serious health problems such as heart or kidney failure, major depression, severe anemia, immunodeficiency, narcolepsy, etc.
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 |
|---|---|---|
| Hearing testAlso: Contralateral supression testHearing and speech tests of MS group and control group in the presence and absence of noise will be evaluated. Suppression test will be performed with OAE test in the presence and absence of noise. | Diagnostic test | Control group, MS group |
| Speech in noise discrimination testSpeech discrimination in noise (SDN) test will be performed in a quiet room in accordance with the Industrial Acoustic Company (IAC) standard using the Grason-Stadler GSI 61 Clinical Audiometer. After pure tone audiometry and speech tests, the GKAE test will be performed. The speech in noise discrimination test will be performed with a signal-to-noise (S/N) ratio of +10 dB. A word list at 50 dB SL will be presented to the tested ear using live sound, while simultaneously white noise at 40 dB SL will be presented to the test ear (Beattie et al. 1997). This will be done for both ears. The speech in noise discrimination test scores will be calculated as percentages (%) for both ears. | Diagnostic test | Control group, MS group |
| Montreal Cognitive Assessment ScaleTranslated into Turkish as the Montreal Cognitive Assessment Scale and abbreviated as MOBID, MOCA assesses attention, executive/managerial functions, memory, visual-spatial skills, language, abstract thinking and arithmetic. It is easy and practical to apply. The score that can be obtained varies between 0-30. The cut-off point for cognitive impairment is 21. Patients who perform below 21 points are considered to have cognitive impairment. Although it is not a battery used in the MS patient group, a study conducted on 39 MS patients and 20 healthy people showed that it can be used safely for screening purposes in patients with MS (Aksoy et al., 2013; Nasreddine et al., 2005; Selekler \& Cangoz, 2009). | Diagnostic test | Control group, MS group |
| Symbol Number Modalities Test (SDMT)Attention, visuospatial information processing speed and working memory are assessed. It is one of the subtests of the Short Repeatable Neuropsychological Battery developed to assess cognitive functions in MS (Smith, 1973). | Diagnostic test | Control group, MS group |
Primary outcome
Pure tone Audiometry Test
Time frame: six month
Air and bone conduction hearing thresholds will be measured using a Grason-Stadler GSI 61 Clinical Audiometer in a quiet room of the Industrial Acoustic Company (IAC) Inc. standard. Airway hearing thresholds will be measured using Telephonics TDH 39 headphones and bone conduction hearing thresholds will be measured using Radioear B-71 bone vibrator. Airway hearing thresholds will be evaluated at frequencies of 0.25 -8 kHz and bone conduction hearing thresholds at 0.5-4 kHz. As pure tone average, 500-1000-2000 Hz air and bone conduction thresholds will be calculated separately for both ears. A pure tone average between 0-15 dB will be considered normal hearing.
Speech Audiometry
Time frame: six month
Speech Audiometry will be performed in a quiet room to IAC (Industrial Acoustic Company) standards using a Grason-Stadler GSI 61 Clinical Audiometer. Speech reception threshold will be determined using three syllable word lists. A 40 dB Sensation Level (SL) will be added above the speech reception threshold and the patient will be asked if he/she can hear comfortably. After determining the level at which the patient can hear most comfortably, 25-word monosyllabic isophonic word lists will be read and the speech discrimination score will be calculated as a percentage. Individuals with a speech discrimination score of 88% and above and with an agreement between speech reception threshold and pure tone averages (SSO) will be included in the study.
Speech Discrimination in Noise Test
Time frame: Six month
The SDN test will be performed in a quiet room in accordance with the Industrial Acoustic Company (IAC) standard using the Grason-Stadler GSI 61 Clinical Audiometer. After pure tone audiometry and speech tests, the GKAE test will be performed. The speech in noise discrimination test will be performed with a signal-to-noise (S/N) ratio of +10 dB. A word list at 50 dB SL will be presented to the tested ear using live sound, while simultaneously white noise at 40 dB SL will be presented to the test ear (Beattie et al. 1997). This will be done for both ears. The speech in noise discrimination test scores will be calculated as percentages (%) for both ears.
Otoacoustic Emission Test
Time frame: Six month
TEOAE measurements of all individuals in the study and control groups will be performed using the computer-based Otodynamics ILO-V6 'cochlear emission analyzer' and software version 5.61 (Otodynamics, London). Adult TEOAE probe will be used for all OAE measurements. The probe will be calibrated in a 1 cc acoustic calibration cavity. The measurement will be performed by averaging the nonlinear, 80 µsec, 260 click stimulus response at 80 ± 3 dB SPL. "Noise rejection level of 47 dB, wave reproducibility of 70% or more, and stimulus stability greater than 80% will be taken into consideration.
Contralateral Suppression Test
Time frame: Six month
For TEOAE and contralateral suppression measurements, 60 dB SL white noise will be applied from the opposite ear using a TEOAE probe and emission amplitudes will be measured from the same side ear. All OAE measurements will be performed by inserting the probe once and TEOAE and contralateral suppression tests will be performed respectively. Amplitude (dB) values obtained with suppression at 1000, 1414, 2000, 2828 and 4000 Hz will be used as study parameters.
2 secondary outcomes
Montreal Cognitive Assessment Scale
Time frame: Six Month
Symbol Digit Modalities Test
Time frame: Six Month
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 24 Apr 2024.
- Individual participant dataSharing planned: No. It will be published as a research article.
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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.
ASUMAN KÜÇÜKÖNER, Dr. principal investigator
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing test, Speech in noise discrimination test and Montreal Cognitive Assessment Scale in people with Multiple Sclerosis-Relapsing-Remitting, run by Asuman Kucukoner at 1 site in Turkey (Türkiye).
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 1 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 24 Apr 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 Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
Pure tone Audiometry Test (time frame: six month). 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 24 Apr 2024.