Sialorrhea True Bulbar Palsy Medullary InjuryNCT07070817
A Clinical Study of Ultrasound-guided Botulinum Toxin A Into Salivary Gland for Sialorrhea After True Bulbar Palsy
A study testing Ultrasound-Guided Botulinum Toxin Type A (BoNT-A) Salivary Gland Injection in people with Sialorrhea True Bulbar Palsy Medullary Injury, run by houyajing at 1 site in China.
Trial summary
Sialorrhea refers to a group of syndromes characterized by excessive saliva secretion from the salivary glands or reduced clearance of oral saliva due to dysphagia, resulting in saliva overflowing from the corners of the mouth or accumulating in the pharynx. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sialorrhea True Bulbar Palsy Medullary Injury
- What is being tested?
- Ultrasound-Guided Botulinum Toxin Type A (BoNT-A) Salivary Gland Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Sep 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:① Aged 18-80 years; ② Cerebral magnetic resonance imaging or computed tomography confirms medullary lesions (hemorrhage, ischemia, or tumor); ③ Dysphagia is clearly diagnosed by flexible endoscopic evaluation of swallowing (FEES); ④ Presence of sialorrhea, which is defined as meeting any one of the following three criteria: total score of the Drooling Severity and Frequency Scale (DSFS-T) ≥ 4 points, each item score of the Drooling Severity and Frequency Scale (DSFS) ≥ 2 points, or score of the Murray Secretion Scale (MSS) for pharyngeal secretions ≥ 2 points; ⑤ Conscious and able to cooperate with sialorrhea assessment and follow-up; ⑥ Willing to receive BTX-A injection, informed of the study details, and sign the relevant informed consent documents.
-
Exclusion Criteria:① Having received BTX-A injection treatment in the recent six months;
- Having an allergy or contraindication to botulinum toxin;
- Having taken drugs for treating sialorrhea or drugs that can cause sialorrhea in the recent month;
- Having severe diseases of important organs such as the heart, lungs, liver, kidneys, or malignant tumors, etc.; ⑤ Concomitantly using aminoglycoside antibiotics and warfarin; ⑥ Patients with infection or skin lesions at the injection site, or severe muscle atrophy at the injection site, or those with infection at the injection site, or skin lesions at the injection site, or severe muscle atrophy at the injection site, or infection.
Trial locations and contacts
1 site in 1 country.
About this study
Sialorrhea refers to a group of syndromes characterized by excessive saliva secretion from the salivary glands or reduced clearance of oral saliva due to dysphagia, resulting in saliva overflowing from the corners of the mouth or accumulating in the pharynx. It is one of the common clinical problems in conditions such as cerebral palsy, Parkinson's disease [1], and brain injuries (including stroke, traumatic brain injury, and hypoxic-ischemic encephalopathy). Among them, true bulbar palsy after medullary injury often causes saliva to flow out from the corners of the mouth due to sensory impairment in the oral cavity, tongue, and pharynx, as well as motor dysfunction and loss of coordination of swallowing-related muscles [2]; on the other hand, it often leads to residual saliva in the hypopharynx due to weakness of the pharyngeal constrictor muscles and dysfunction of the upper esophageal sphincter [3]. Sialorrhea can not only cause oral odor, skin breakdown, and malnutrition but also have a negative impact on patients' psychology, and even lead to choking or aspiration pneumonia, seriously endangering their physical and mental health. Therefore, active management and treatment of sialorrhea in patients with true bulbar palsy have become the key to solving this problem.
Currently, the management of sialorrhea mainly involves improving swallowing function to enhance saliva clearance and using drug intervention to reduce saliva secretion, thereby alleviating sialorrhea symptoms. However, current studies have found that swallowing function cannot recover quickly in a short time in patients with medullary injury. Therefore, active intervention is needed to reduce saliva secretion to relieve sialorrhea symptoms. Clinical treatments for sialorrhea include drug therapy, botulinum toxin therapy, radiation therapy, and surgical treatment. Among them, oral drug therapy is mainly based on antimuscarinic drugs. Although it has a certain therapeutic effect, its clinical application is limited due to the side effects of systemic anticholinergic effects; while surgical treatment is not clinically adopted because of its high destructiveness.
In recent years, a number of clinical studies on botulinum toxin type A (BTX-A) in the treatment of sialorrhea in adults (Parkinson's disease, traumatic brain injury) and children (cerebral palsy) have been carried out at home and abroad, and its efficacy and safety have been verified [4] [5]. However, there are few reports on BTX-A in the treatment of sialorrhea in patients with medullary lesions. Therefore, this study aims to conduct a randomized controlled trial to explore the effect of ultrasound-guided botulinum toxin type A injection into the salivary glands on sialorrhea in patients with true bulbar palsy, and comprehensively evaluate the efficacy and safety of BTX-A in the treatment of sialorrhea by combining subjective scale assessment and objective instrument assessment.
- Being tested
- Ultrasound-Guided Botulinum Toxin Type A (BoNT-A) Salivary Gland Injection, Control (Normal saline)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Botulinum Toxin Type A (BoNT-A) Salivary Gland InjectionDrug
Ultrasound-guided injection of BoNT-A (specific dosage, e.g., "100 units") into target salivary glands ( parotid and submandibular glands) at baseline.
Control (Normal saline)Drug
Intervention: Participants receive routine swallowing rehabilitation training only.
Details of training: The training includes standard techniques to improve swallowing function, such as oral motor training, empty swallowing exercises, and ice stimulation. The frequency and duration of training are consistent across all participants in this arm to ensure standardization.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Botulinum Toxin Type A (BoNT-A) Salivary Gland Injection Group | Experimental | Experimental Arm (Group B) Intervention: Participants receive ultrasound-guided A 100IU (BTX-A) injection into the salivary glands combined with the same routine swallowing rehabilitation training as the control arm.
Details of BTX-A injection:
BTX-A is diluted with 2 mL of 0.9% NaCl. Injections are administered under ultrasound guidance, targeting the parotid and submandibular glands (specific dosage and injection sites follow clinical standards).
Rehabilitation training: Identical in content, frequency, and duration to the control arm, ensuring that any differences in outcomes can be attributed to the BTX-A injection. Receives: Drug: Ultrasound-Guided Botulinum Toxin Type A (BoNT-A) Salivary Gland Injection |
| Ultrasound-Guided Saline (Placebo) Salivary Gland Injection Group | Placebo comparator | Description: This arm includes participants with true bulbar palsy and sialorrhea who will receive ultrasound-guided injections of a placebo (sterile saline) into the salivary glands. It serves as a control to compare against the active intervention arm. Receives: Drug: Control (Normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Impression of Change Scale (GICS) assessment:
This scale rates the patient's current condition by comparing it with the initial condition, with scores ranging from 0 to 7. The specific criteria are as follows:
This scale rates the patient's current condition by comparing it with the initial condition, with scores ranging from 0 to 7. The specific criteria are as follows:
0 points: Not evaluated
- point: Significant improvement
- points: Improvement
- points: Slight improvement
- points: No change
- points: Slight deterioration
- points: Deterioration
- points: Severe deterioration
Measured: The Global Impression of Change Scale (GICS) will be used to assess symptoms at 1 week, 2 weeks, and 4 weeks after injection treatment.
Secondary outcomes (6)
Flexible Endoscopic Evaluation of Swallowing (FEES) combined with Murray Secretion Scale (MSS) assessment:
A flexible laryngoscope is inserted through one nostril to observe the retention of secretions in the vallecula epiglottica, piriform fossa, and laryngeal vestibule, and the MSS is used for scoring. The scoring criteria are as follows:
0 points: No secretions in the vallecula epiglottica and piriform fossa
- point: A small amount of secretions in the vallecula epiglottica and piriform fossa
- points: Temporary accumulation of secretions in the laryngeal vestibule
- points: Persistent accumulation of secretions in the laryngeal vestibule
Measured: Murray Secretion Scale (MSS) will be used to assess the patients' sialorrhea symptoms before BTX-A treatment, as well as 1 week, 2 weeks, and 4 weeks after treatment, respectively.
Assessment with Drooling Severity and Frequency Scale (DSFS)
Drooling Severity Scale (DSFS-S): The score ranges from 1 to 5, with 1 point indicating normal; 2 points indicating mild (only the lips are moist); 3 points indicating moderate (the mouth and chin are moist); 4 points indicating severe (clothes are damp); 5 points indicating persistent drooling (clothes, hands and surrounding objects are moist).
Drooling Frequency Scale (DSFS-F): The score ranges from 1 to 5, with 1 point indicating no drooling; 2 points indicating occasional drooling (not every day); 3 points indicating frequent drooling (some time every day); 4 points indicating constant drooling.
The total score of the overall scale is the sum of the scores of the two subscales, ranging from 2 to 9 points. A score of 2 indicates no drooling, and a score of 9 indicates severe drooling. A higher score suggests a more severe degree of drooling.
Measured: The Drooling Severity Scale (DSFS-S), Drooling Frequency Scale (DSFS-F) will be used to assess the patients' sialorrhea symptoms before BTX-A treatment, as well as 1 week, 2 weeks, and 4 weeks after treatment, respectively.
Assessment with Hamilton Anxiety Scale
All items are evaluated using a 5-level scoring method with scores ranging from 0 to 4: 0 points indicate no symptoms; 1 point indicates mild symptoms; 2 points indicate moderate symptoms; 3 points indicate severe symptoms; 4 points indicate extremely severe symptoms.
A total score of <7 points indicates no anxiety, 7-13 points indicates possible anxiety, 14-20 points indicates anxiety, 21-28 points indicates obvious anxiety, and ≥29 points indicates severe anxiety. Among them, a score of ≥14 points suggests that the evaluated person has clinically significant anxiety symptoms.
Measured: The incidence of depression in the two groups of patients will be compared before BTX-A treatment and2weeks and 4 weeks a after treatment.
Assessment with Hamilton Depression Scale
Most items are evaluated using a 5-level scoring method with scores ranging from 0 to 4 (0 points indicate no symptoms; 1 point indicates mild symptoms; 2 points indicate moderate symptoms; 3 points indicate severe symptoms; 4 points indicate extremely severe symptoms); a few items are evaluated using a 3-level scoring method with scores ranging from 0 to 2 (0 points indicate no symptoms; 1 point indicates mild to moderate symptoms; 2 points indicate severe symptoms).
A total score of <8 points indicates no depression, 8-19 points indicates possible depression, 20-34 points indicates mild or moderate depression, and ≥35 points indicates severe depression. Among them, a score of ≥20 points suggests that the patient has clinically significant depressive symptoms.
Measured: The incidence of Anxiety in the two groups of patients will be compared before BTX-A treatment and 2weeks and 4 weeks after treatment.
Occurrence of Pulmonary Infection
It is judged according to the diagnostic criteria for stroke-associated pneumonia, that is, chest imaging examination reveals new or progressive pulmonary infiltrative lesions, accompanied by more than 2 clinical infection symptoms (such as fever > 38℃; new onset of cough and expectoration or aggravation of original respiratory disease symptoms, with dyspnea or tachypnea, respiratory rate > 25 times/min; signs of pulmonary consolidation and/or rales; peripheral blood leukocytes > 10.0×10⁹/L or < 4.0×10⁹/L, excluding interstitial lung changes, pulmonary edema, atelectasis, and pulmonary embolism); or age ≥ 70 years old with altered consciousness for no other clear reasons.
Measured: The incidence of stroke-associated pneumonia in the two groups of patients will be compared before BTX-A treatment and 2 weeks after treatment.
The main indicators include prealbumin, serum albumin (Alb), and hemoglobin (Hb).
Measured: The improvement of nutritional status in the two groups of patients will be compared before BTX-A treatment and 2 weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Why it stopped: In accordance with the time-limit regulations for ethical review, since the ethical approval certificate of this study protocol has expired, I hereby formally apply for the withdrawal of this study from the clinical trial registration platform.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sialorrhea True Bulbar Palsy Medullary InjuryStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a interventional study designed to evaluate the efficacy and safety of ultrasound-guided botulinum toxin type A (BTX-A) injection into salivary glands for treating sialorrhea in patients with true bulbar palsy. 1.Study Design Type 1.1Control group (Group A): Routine swallowing rehabilitation training. 1.2Experimental group (Group B): Ultrasound-guided BTX-A injection into the parotid and submandibular glands, combined with the same routine swallowing rehabilitation training as the control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- houyajing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, houyajing, Fu Xing Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070817
- Sponsor's protocol ID
- 2024FXHEC-KSP017
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Ultrasound-guided Botulinum Toxin A Into Salivary Gland for Sialorrhea After True Bulbar Palsy
- ClinicalTrials.gov ID
- NCT07070817
- Acronym / sponsor ID
- 2024FXHEC-KSP017
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: In accordance with the time-limit regulations for ethical review, since the ethical approval certificate of this study protocol has expired, I hereby formally apply for the withdrawal of this study from the clinical trial registration platform.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- houyajingUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 17 Jul 2025 (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.
Sialorrhea refers to a group of syndromes characterized by excessive saliva secretion from the salivary glands or reduced clearance of oral saliva due to dysphagia, resulting in saliva overflowing from the corners of the mouth or accumulating in the pharynx. It is one of the common clinical problems in conditions such as cerebral palsy, Parkinson's disease [1], and brain injuries (including stroke, traumatic brain injury, and hypoxic-ischemic encephalopathy). Among them, true bulbar palsy after medullary injury often causes saliva to flow out from the corners of the mouth due to sensory impairment in the oral cavity, tongue, and pharynx, as well as motor dysfunction and loss of coordination of swallowing-related muscles [2]; on the other hand, it often leads to residual saliva in the hypopharynx due to weakness of the pharyngeal constrictor muscles and dysfunction of the upper esophageal sphincter [3]. Sialorrhea can not only cause oral odor, skin breakdown, and malnutrition but also have a negative impact on patients' psychology, and even lead to choking or aspiration pneumonia, seriously endangering their physical and mental health. Therefore, active management and treatment of sialorrhea in patients with true bulbar palsy have become the key to solving this problem.
Currently, the management of sialorrhea mainly involves improving swallowing function to enhance saliva clearance and using drug intervention to reduce saliva secretion, thereby alleviating sialorrhea symptoms. However, current studies have found that swallowing function cannot recover quickly in a short time in patients with medullary injury. Therefore, active intervention is needed to reduce saliva secretion to relieve sialorrhea symptoms. Clinical treatments for sialorrhea include drug therapy, botulinum toxin therapy, radiation therapy, and surgical treatment. Among them, oral drug therapy is mainly based on antimuscarinic drugs. Although it has a certain therapeutic effect, its clinical application is limited due to the side effects of systemic anticholinergic effects; while surgical treatment is not clinically adopted because of its high destructiveness.
In recent years, a number of clinical studies on botulinum toxin type A (BTX-A) in the treatment of sialorrhea in adults (Parkinson's disease, traumatic brain injury) and children (cerebral palsy) have been carried out at home and abroad, and its efficacy and safety have been verified [4] [5]. However, there are few reports on BTX-A in the treatment of sialorrhea in patients with medullary lesions. Therefore, this study aims to conduct a randomized controlled trial to explore the effect of ultrasound-guided botulinum toxin type A injection into the salivary glands on sialorrhea in patients with true bulbar palsy, and comprehensively evaluate the efficacy and safety of BTX-A in the treatment of sialorrhea by combining subjective scale assessment and objective instrument assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a interventional study designed to evaluate the efficacy and safety of ultrasound-guided botulinum toxin type A (BTX-A) injection into salivary glands for treating sialorrhea in patients with true bulbar palsy. 1.Study Design Type 1.1Control group (Group A): Routine swallowing rehabilitation training. 1.2Experimental group (Group B): Ultrasound-guided BTX-A injection into the parotid and submandibular glands, combined with the same routine swallowing rehabilitation training as the control group.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Botulinum Toxin Type A (BoNT-A) Salivary Gland Injection Group | Experimental | Drug: Ultrasound-Guided Botulinum Toxin Type A (BoNT-A) Salivary Gland InjectionExperimental Arm (Group B) Intervention: Participants receive ultrasound-guided A 100IU (BTX-A) injection into the salivary glands combined with the same routine swallowing rehabilitation training as the control arm. Details of BTX-A injection: BTX-A is diluted with 2 mL of 0.9% NaCl. Injections are administered under ultrasound guidance, targeting the parotid and submandibular glands (specific dosage and injection sites follow clinical standards). Rehabilitation training: Identical in content, frequency, and duration to the control arm, ensuring that any differences in outcomes can be attributed to the BTX-A injection. |
| Ultrasound-Guided Saline (Placebo) Salivary Gland Injection Group | Placebo comparator | Drug: Control (Normal saline)Description: This arm includes participants with true bulbar palsy and sialorrhea who will receive ultrasound-guided injections of a placebo (sterile saline) into the salivary glands. It serves as a control to compare against the active intervention arm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Ultrasound-Guided Botulinum Toxin Type A (BoNT-A) Salivary Gland InjectionUltrasound-guided injection of BoNT-A (specific dosage, e.g., "100 units") into target salivary glands ( parotid and submandibular glands) at baseline. | Drug | Ultrasound-Guided Botulinum Toxin Type A (BoNT-A) Salivary Gland Injection Group |
| Control (Normal saline)Intervention: Participants receive routine swallowing rehabilitation training only. Details of training: The training includes standard techniques to improve swallowing function, such as oral motor training, empty swallowing exercises, and ice stimulation. The frequency and duration of training are consistent across all participants in this arm to ensure standardization. | Drug | Ultrasound-Guided Saline (Placebo) Salivary Gland Injection Group |
Primary outcome
Global Impression of Change Scale (GICS) assessment:
Time frame: The Global Impression of Change Scale (GICS) will be used to assess symptoms at 1 week, 2 weeks, and 4 weeks after injection treatment.
This scale rates the patient's current condition by comparing it with the initial condition, with scores ranging from 0 to 7. The specific criteria are as follows: This scale rates the patient's current condition by comparing it with the initial condition, with scores ranging from 0 to 7. The specific criteria are as follows: 0 points: Not evaluated 1. point: Significant improvement 2. points: Improvement 3. points: Slight improvement 4. points: No change 5. points: Slight deterioration 6. points: Deterioration 7. points: Severe deterioration
6 secondary outcomes
Flexible Endoscopic Evaluation of Swallowing (FEES) combined with Murray Secretion Scale (MSS) assessment:
Time frame: Murray Secretion Scale (MSS) will be used to assess the patients' sialorrhea symptoms before BTX-A treatment, as well as 1 week, 2 weeks, and 4 weeks after treatment, respectively.
Assessment with Drooling Severity and Frequency Scale (DSFS)
Time frame: The Drooling Severity Scale (DSFS-S), Drooling Frequency Scale (DSFS-F) will be used to assess the patients' sialorrhea symptoms before BTX-A treatment, as well as 1 week, 2 weeks, and 4 weeks after treatment, respectively.
Assessment with Hamilton Anxiety Scale
Time frame: The incidence of depression in the two groups of patients will be compared before BTX-A treatment and2weeks and 4 weeks a after treatment.
Assessment with Hamilton Depression Scale
Time frame: The incidence of Anxiety in the two groups of patients will be compared before BTX-A treatment and 2weeks and 4 weeks after treatment.
Occurrence of Pulmonary Infection
Time frame: The incidence of stroke-associated pneumonia in the two groups of patients will be compared before BTX-A treatment and 2 weeks after treatment.
The main indicators include prealbumin, serum albumin (Alb), and hemoglobin (Hb).
Time frame: The improvement of nutritional status in the two groups of patients will be compared before BTX-A treatment and 2 weeks after treatment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Botulinum Toxin Type A (BoNT-A) Salivary Gland Injection in people with Sialorrhea True Bulbar Palsy Medullary Injury, run by houyajing 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?
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: withdrawn, as of the sponsor's last update on 24 Jun 2026. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Global Impression of Change Scale (GICS) assessment: (time frame: The Global Impression of Change Scale (GICS) will be used to assess symptoms at 1 week, 2 weeks, and 4 weeks after injection treatment.). 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 Jun 2026.