Stellate GanglionNCT06112392
Clinical Study of Stellate Ganglion Block in Treatment of Patients With Advanced Primary Parkinson's Disease
A study testing Treatment （Stellate ganglion block；Oral standard anti-Parkinson's drugs） and Treatment （Oral standard anti-Parkinson's drugs） in people with Stellate Ganglion and Parkinson Disease, run by Zhujiang Hospital at 1 site in China.
Trial summary
At present, there are no reports on the application of stellate ganglion block in the treatment of Parkinson's disease patients at home and abroad. Based on the preliminary clinical observation, this project intends to apply stellate ganglion block in the treatment of patients with intermediate and advanced… Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stellate Ganglion, Parkinson Disease
- What is being tested?
- Treatment （Stellate ganglion block；Oral standard anti-Parkinson's drugs） and Treatment （Oral standard anti-Parkinson's drugs）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2023to 30 Jun 2024
- 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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with Parkinson's disease who met the diagnostic criteria for MDS as "probable PD" or" confirmed PD" in 2016
- Age 40-85;
- Patients with Parkinson's disease who met the diagnostic criteria of MDS as "probable PD" or" confirmed PD" in 2016;
- The patient or his/her legal guardian agrees to participate in the study and signs the informed consent;
- Hoehn-yahr (H\&Y) 2.5 ~ 5;
Who cannot join
- 1. Allergic to local anesthetic drugs;
- 2. Unable to cooperate with motor or non-motor function monitoring;
- 3. Patients with Parkinson's superposition syndrome, such as cortical basal ganglia degeneration, lewy body dementia, multisystem atrophy and progressive supranuclear palsy, were excluded; Patients with secondary Parkinson's disease, such as vascular Parkinson's disease, drug toxicity or traumatic Parkinson's disease;
- 4. Refuse to sign the consent form.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospiatal
Guangzhou, Guangdong, 510000
Xiaoya Gao, 86-18680282869, gaoxy23@126.com
About this study
Official title: Stellate Ganglion Block in Patients With Advanced Primary Parkinson's Disease: a Small, Open, Randomized Controlled Clinical Study
At present, there are no reports on the application of stellate ganglion block in the treatment of Parkinson's disease patients at home and abroad. Based on the preliminary clinical observation, this project intends to apply stellate ganglion block in the treatment of patients with intermediate and advanced Parkinson's disease through an open, randomized controlled small sample clinical study. To determine whether stellate ganglion block can effectively improve motor symptoms and non-motor symptoms in patients with primary advanced Parkinson's disease.
Read the detailed description
Parkinson's disease (PD) is a relatively common degenerative disease of the central nervous system. In the past few decades, China's population has increased significantly, resulting in a rapid increase in the number of elderly people. According to the 2016 Global Burden of Disease study, the number of PD patients in China accounts for about 23% of the global PD population. By the end of 2020, the estimated number of people living with Parkinson's disease in China is about 3.62 million, and it is expected that by 2030, 50% of the world's PD patients will be Chinese. The main manifestations of Parkinson's disease are motor symptoms such as bradykinesia, myotonia and tremor, and non-motor symptoms such as autonomic nervous dysfunction, sleep disturbance and anosmia.
Both motor symptoms and non-motor symptoms can significantly affect patients' quality of life. At present, the domestic and foreign treatment guidelines for Parkinson's disease still prefer drug therapy represented by dopa. However, in the middle and late stages of the disease, side effects such as symptom fluctuation or hyperactivity disorder complicated by long-term drug use gradually appear, and the efficacy of patients on levodopa declines, which seriously affects the quality of life of patients. For patients with advanced Parkinson's disease, current anti-Parkinson's guidelines advocate a combination of drug therapy and non-drug therapy. As a major non-drug treatment for Parkinson's disease, deep brain stimulation (DBS) has limited its wide clinical application due to its complex, invasive, expensive, and many side effects, while conventional rehabilitation therapy is limited to functional exercise such as speech and swallowing, with limited efficacy. Therefore, the search for new treatments for Parkinson's disease is imperative.
At present, there are no reports about the application of SGB in the treatment of patients with Parkinson's disease at home and abroad. Based on the preliminary clinical observation, this study intends to apply SGB in the treatment of patients with advanced Parkinson's disease through an open, randomized controlled small sample clinical study, so as to confirm that SGB can effectively improve the motor symptoms and non-motor symptoms of patients with advanced Parkinson's disease.
- Conditions
- Stellate Ganglion, Parkinson Disease
- Being tested
- Treatment （Stellate ganglion block；Oral standard anti-Parkinson's drugs）, Treatment （Oral standard anti-Parkinson's drugs）
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment （Stellate ganglion block；Oral standard anti-Parkinson's drugs）Diagnostic test
Treatment （Stellate ganglion block；Oral standard anti-Parkinson's drugs）
Treatment （Oral standard anti-Parkinson's drugs）Diagnostic test
Treatment （Oral standard anti-Parkinson's drugs）
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease group | Experimental | Diagnostic criteria: Patients with Parkinson's disease who met the diagnostic criteria for MDS as "probable PD" or" confirmed PD" in 2016
Inclusion criteria:
1. Age 40-85;
2. Patients with Parkinson's disease who met the diagnostic criteria of MDS as "probable PD" or" confirmed PD" in 2016;
3. The patient or his/her legal guardian agrees to participate in the study and signs the informed consent;
4. Hoehn-yahr (H\&Y) 3 ~ 5; Receives: Diagnostic Test: Treatment （Stellate ganglion block；Oral standard anti-Parkinson's drugs） |
| Non-parkinson's disease group | Experimental | Exclusion criteria:
1. Allergic to local anesthetic drugs;
2. Unable to cooperate with motor or non-motor function monitoring;
3. Patients with Parkinson's superposition syndrome, such as cortical basal ganglia degeneration, lewy body dementia, multisystem atrophy and progressive supranuclear palsy, were excluded; Patients with secondary Parkinson's disease, such as vascular Parkinson's disease, drug toxicity or traumatic Parkinson's disease;
4. Refuse to sign the consent form. Receives: Diagnostic Test: Treatment （Oral standard anti-Parkinson's drugs） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved MDS-UPDRS scale scoring
The revised Movement Disorders Association Unified Parkinson's Disease Rating Scale has four major components, all of which include both physician and patient aspects. The first component is psychological, behavioral and emotional. The second part is daily life activities; The third part is motor symptoms; The fourth part is complications.
Measured: 12 weeks
Secondary outcomes (7)
NMSS (Non-motor Symptom Evaluation Scale)
Non-motor Symptom Evaluation Scale, minimum value 0 points, maximum 360 points. The higher the score, the worse the condition.
Measured: 12 weeks
Pdq-39 (Self-rating Scale for clinical evaluation of quality of life in patients with Kinson disease)
Self-rating Scale for clinical evaluation of quality of life in patients with Kinson disease, minimum value 0 points, maximum 156 points. The higher the score, the worse the condition.
Measured: 12 weeks
H&Y classification (Classification of Parkinson's disease)
Classification of Parkinson's disease, minimum value 0 points, maximum 5 points. The higher the score, the worse the condition.
Measured: 12 weeks
LDE (Levodopa Equivalent dose)
Levodopa Equivalent dose, based on the dose of different anti-Parkinson's drugs. The higher the score, the worse the condition.
Measured: 12 weeks
Hamilton Anxiety Scale (HAMA)
Hamilton Anxiety Scale, minimum value 0 points, maximum 56 points. The higher the score, the worse the condition.
Measured: 12 weeks
Parkinson's Disease Sleep Scale (PDSS)
Parkinson's Disease Sleep Scale, minimum value 0 points, maximum 150 points. The higher the score, the better the patient.
Measured: 12 weeks
Montreal Cognitive Assessment Scale
Montreal Cognitive Assessment Scale, minimum value 0 points, maximum 30 points. The higher the score, the better the patient.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start28 Jul 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Stellate GanglionStudies of the same condition, open and under way.
- More trials run by Zhujiang 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Xiaoya, Zhujiang Hospital
- Investigators
- Xiaoya Gao, doctor, Principal investigator, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112392
- Sponsor's protocol ID
- 2022-KY-080-01
- Status last verified
- Jan 2024
- First submitted
- 13 Jul 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qi S, Yin P, Wang L, Qu M, Kan GL, Zhang H, Zhang Q, Xiao Y, Deng Y, Dong Z, Shi Y, Meng J, Chan P, Wang Z. Prevalence of Parkinson's Disease: A Community-Based Study in China. Mov Disord. 2021 Dec;36(12):2940-2944. doi: 10.1002/mds.28762. Epub 2021 Aug 14.
PubMed 34390510Santos-Garcia D, de la Fuente-Fernandez R. Impact of non-motor symptoms on health-related and perceived quality of life in Parkinson's disease. J Neurol Sci. 2013 Sep 15;332(1-2):136-40. doi: 10.1016/j.jns.2013.07.005. Epub 2013 Jul 25.
PubMed 23890935Jost WH, Buhmann C. The challenge of pain in the pharmacological management of Parkinson's disease. Expert Opin Pharmacother. 2019 Oct;20(15):1847-1854. doi: 10.1080/14656566.2019.1639672. Epub 2019 Jul 10.
PubMed 31290336Stozek J, Rudzinska M, Pustulka-Piwnik U, Szczudlik A. The effect of the rehabilitation program on balance, gait, physical performance and trunk rotation in Parkinson's disease. Aging Clin Exp Res. 2016 Dec;28(6):1169-1177. doi: 10.1007/s40520-015-0506-1. Epub 2015 Dec 10.
PubMed 26661467Bi Y, Wang B, Yin Z, Zhang G, Chen H, Wang M. [Effects of stellate ganglion block on AMP-ativated protein kinase and astrocyte in hippocampal neurons in postoperative aged rats]. Zhonghua Yi Xue Za Zhi. 2014 Jul 22;94(28):2222-6. Chinese.
PubMed 25331477Dai D, Zheng B, Yu Z, Lin S, Tang Y, Chen M, Ke P, Zheng C, Chen Y, Wu X. Right stellate ganglion block improves learning and memory dysfunction and hippocampal injury in rats with sleep deprivation. BMC Anesthesiol. 2021 Nov 8;21(1):272. doi: 10.1186/s12871-021-01486-4.
PubMed 34749669Uchida K, Tateda T, Hino H. Novel mechanism of action hypothesized for stellate ganglion block related to melatonin. Med Hypotheses. 2002 Oct;59(4):446-9. doi: 10.1016/s0306-9877(02)00158-5.
PubMed 12208186Moon HS, Chon JY, Lee SH, Ju YM, Sung CH. Long-term Results of Stellate Ganglion Block in Patients with Olfactory Dysfunction. Korean J Pain. 2013 Jan;26(1):57-61. doi: 10.3344/kjp.2013.26.1.57. Epub 2013 Jan 4.
PubMed 23342209
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stellate Ganglion Block in Patients With Advanced Primary Parkinson's Disease: a Small, Open, Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06112392
- Acronym / sponsor ID
- 2022-KY-080-01
- Conditions
- Stellate Ganglion, Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 1 Nov 2023 (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.
At present, there are no reports on the application of stellate ganglion block in the treatment of Parkinson's disease patients at home and abroad. Based on the preliminary clinical observation, this project intends to apply stellate ganglion block in the treatment of patients with intermediate and advanced Parkinson's disease through an open, randomized controlled small sample clinical study. To determine whether stellate ganglion block can effectively improve motor symptoms and non-motor symptoms in patients with primary advanced Parkinson's disease.
Detailed description
Parkinson's disease (PD) is a relatively common degenerative disease of the central nervous system. In the past few decades, China's population has increased significantly, resulting in a rapid increase in the number of elderly people. According to the 2016 Global Burden of Disease study, the number of PD patients in China accounts for about 23% of the global PD population. By the end of 2020, the estimated number of people living with Parkinson's disease in China is about 3.62 million, and it is expected that by 2030, 50% of the world's PD patients will be Chinese. The main manifestations of Parkinson's disease are motor symptoms such as bradykinesia, myotonia and tremor, and non-motor symptoms such as autonomic nervous dysfunction, sleep disturbance and anosmia.
Both motor symptoms and non-motor symptoms can significantly affect patients' quality of life. At present, the domestic and foreign treatment guidelines for Parkinson's disease still prefer drug therapy represented by dopa. However, in the middle and late stages of the disease, side effects such as symptom fluctuation or hyperactivity disorder complicated by long-term drug use gradually appear, and the efficacy of patients on levodopa declines, which seriously affects the quality of life of patients. For patients with advanced Parkinson's disease, current anti-Parkinson's guidelines advocate a combination of drug therapy and non-drug therapy. As a major non-drug treatment for Parkinson's disease, deep brain stimulation (DBS) has limited its wide clinical application due to its complex, invasive, expensive, and many side effects, while conventional rehabilitation therapy is limited to functional exercise such as speech and swallowing, with limited efficacy. Therefore, the search for new treatments for Parkinson's disease is imperative.
At present, there are no reports about the application of SGB in the treatment of patients with Parkinson's disease at home and abroad. Based on the preliminary clinical observation, this study intends to apply SGB in the treatment of patients with advanced Parkinson's disease through an open, randomized controlled small sample clinical study, so as to confirm that SGB can effectively improve the motor symptoms and non-motor symptoms of patients with advanced Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease group | Experimental | Diagnostic Test: Treatment （Stellate ganglion block；Oral standard anti-Parkinson's drugs）Diagnostic criteria: Patients with Parkinson's disease who met the diagnostic criteria for MDS as "probable PD" or" confirmed PD" in 2016 Inclusion criteria: 1. Age 40-85; 2. Patients with Parkinson's disease who met the diagnostic criteria of MDS as "probable PD" or" confirmed PD" in 2016; 3. The patient or his/her legal guardian agrees to participate in the study and signs the informed consent; 4. Hoehn-yahr (H\&Y) 3 ~ 5; |
| Non-parkinson's disease group | Experimental | Diagnostic Test: Treatment （Oral standard anti-Parkinson's drugs）Exclusion criteria: 1. Allergic to local anesthetic drugs; 2. Unable to cooperate with motor or non-motor function monitoring; 3. Patients with Parkinson's superposition syndrome, such as cortical basal ganglia degeneration, lewy body dementia, multisystem atrophy and progressive supranuclear palsy, were excluded; Patients with secondary Parkinson's disease, such as vascular Parkinson's disease, drug toxicity or traumatic Parkinson's disease; 4. Refuse to sign the consent form. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with Parkinson's disease who met the diagnostic criteria for MDS as "probable PD" or" confirmed PD" in 2016
- Age 40-85;
- Patients with Parkinson's disease who met the diagnostic criteria of MDS as "probable PD" or" confirmed PD" in 2016;
- The patient or his/her legal guardian agrees to participate in the study and signs the informed consent;
- Hoehn-yahr (H\&Y) 2.5 ~ 5;
Key exclusion criteria (4 listed)
- 1. Allergic to local anesthetic drugs;
- 2. Unable to cooperate with motor or non-motor function monitoring;
- 3. Patients with Parkinson's superposition syndrome, such as cortical basal ganglia degeneration, lewy body dementia, multisystem atrophy and progressive supranuclear palsy, were excluded; Patients with secondary Parkinson's disease, such as vascular Parkinson's disease, drug toxicity or traumatic Parkinson's disease;
- 4. Refuse to sign the consent form.
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 |
|---|---|---|
| Treatment （Stellate ganglion block；Oral standard anti-Parkinson's drugs）Treatment （Stellate ganglion block；Oral standard anti-Parkinson's drugs） | Diagnostic test | Parkinson's disease group |
| Treatment （Oral standard anti-Parkinson's drugs）Treatment （Oral standard anti-Parkinson's drugs） | Diagnostic test | Non-parkinson's disease group |
Primary outcome
Improved MDS-UPDRS scale scoring
Time frame: 12 weeks
The revised Movement Disorders Association Unified Parkinson's Disease Rating Scale has four major components, all of which include both physician and patient aspects. The first component is psychological, behavioral and emotional. The second part is daily life activities; The third part is motor symptoms; The fourth part is complications.
7 secondary outcomes
NMSS (Non-motor Symptom Evaluation Scale)
Time frame: 12 weeks
Pdq-39 (Self-rating Scale for clinical evaluation of quality of life in patients with Kinson disease)
Time frame: 12 weeks
H&Y classification (Classification of Parkinson's disease)
Time frame: 12 weeks
LDE (Levodopa Equivalent dose)
Time frame: 12 weeks
Hamilton Anxiety Scale (HAMA)
Time frame: 12 weeks
Parkinson's Disease Sleep Scale (PDSS)
Time frame: 12 weeks
Montreal Cognitive Assessment Scale
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Results publication: PubMed 34390510Qi S, Yin P, Wang L, Qu M, Kan GL, Zhang H, Zhang Q, Xiao Y, Deng Y, Dong Z, Shi Y, Meng J, Chan P, Wang Z. Prevalence of Parkinson's Disease: A Community-Based Study in China. Mov Disord. 2021 Dec;36(12):2940-2944. doi: 10.1002/mds.28762. Epub 2021 Aug 14.
- Results publication: PubMed 23890935Santos-Garcia D, de la Fuente-Fernandez R. Impact of non-motor symptoms on health-related and perceived quality of life in Parkinson's disease. J Neurol Sci. 2013 Sep 15;332(1-2):136-40. doi: 10.1016/j.jns.2013.07.005. Epub 2013 Jul 25.
- Results publication: PubMed 31290336Jost WH, Buhmann C. The challenge of pain in the pharmacological management of Parkinson's disease. Expert Opin Pharmacother. 2019 Oct;20(15):1847-1854. doi: 10.1080/14656566.2019.1639672. Epub 2019 Jul 10.
- Results publication: PubMed 26661467Stozek J, Rudzinska M, Pustulka-Piwnik U, Szczudlik A. The effect of the rehabilitation program on balance, gait, physical performance and trunk rotation in Parkinson's disease. Aging Clin Exp Res. 2016 Dec;28(6):1169-1177. doi: 10.1007/s40520-015-0506-1. Epub 2015 Dec 10.
- Results publication: PubMed 25331477Bi Y, Wang B, Yin Z, Zhang G, Chen H, Wang M. [Effects of stellate ganglion block on AMP-ativated protein kinase and astrocyte in hippocampal neurons in postoperative aged rats]. Zhonghua Yi Xue Za Zhi. 2014 Jul 22;94(28):2222-6. Chinese.
- Results publication: PubMed 34749669Dai D, Zheng B, Yu Z, Lin S, Tang Y, Chen M, Ke P, Zheng C, Chen Y, Wu X. Right stellate ganglion block improves learning and memory dysfunction and hippocampal injury in rats with sleep deprivation. BMC Anesthesiol. 2021 Nov 8;21(1):272. doi: 10.1186/s12871-021-01486-4.
- Results publication: PubMed 12208186Uchida K, Tateda T, Hino H. Novel mechanism of action hypothesized for stellate ganglion block related to melatonin. Med Hypotheses. 2002 Oct;59(4):446-9. doi: 10.1016/s0306-9877(02)00158-5.
- Results publication: PubMed 23342209Moon HS, Chon JY, Lee SH, Ju YM, Sung CH. Long-term Results of Stellate Ganglion Block in Patients with Olfactory Dysfunction. Korean J Pain. 2013 Jan;26(1):57-61. doi: 10.3344/kjp.2013.26.1.57. Epub 2013 Jan 4.
- 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.
Xiaoya Gao, doctor principal investigator
Southern Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment （Stellate ganglion block；Oral standard anti-Parkinson's drugs） and Treatment （Oral standard anti-Parkinson's drugs） in people with Stellate Ganglion and Parkinson Disease, run by Zhujiang Hospital at 1 site in China.
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 5 inclusion and 4 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 31 Jan 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoya Gao, doctor (86-18680282869, gaoxy23@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved MDS-UPDRS scale scoring (time frame: 12 weeks). 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 NCT06112392, which also lists 8 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 31 Jan 2024.