SialorrheaNCT07881497
A Retrospective Chart Abstraction to Investigate the Prevalence of Chronic Sialorrhea, and the Real-world Use of incobotulinumtoxinA Injections in Male and Female Participants Aged 18 Years and Older With Chronic Sialorrhea
An observational study of Sialorrhea, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
A retrospective, multicenter chart abstraction to investigate the prevalence of chronic sialorrhea, and the real-world use of incobotulinumtoxinA injections in male and female participants aged 18 years and older with chronic sialorrhea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sialorrhea
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2025to 30 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recruitment occurs at MedStar Health-affiliated sites including: * Georgetown University Hospital, Washington, DC * Center for Neurodegenerative Diseases, McLean, VA * MedStar Montgomery Medical Center, Olney, MD * MedStar Washington Hospital Center, Washington, DC * MedStar Franklin Square Medical Center, Baltimore, MD
Who may be able to join
- Age 18 years and older
- Diagnosed with Sialorrhea
- Presence of comprehensive patient data
Who cannot join
- Lack of data about Sialorrhea and its treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Montgomery Medical Center
Olney, Maryland, 20832
About this study
Official title: A Retrospective, Multicenter Chart Abstraction to Investigate the Prevalence of Chronic Sialorrhea, and the Real-world Use of incobotulinumtoxinA Injections in Male and Female Participants Aged 18 Years and Older With Chronic Sialorrhea
A retrospective, multicenter chart abstraction to investigate the prevalence of chronic sialorrhea, and the real-world use of incobotulinumtoxinA injections in male and female participants aged 18 years and older with chronic sialorrhea. Patients who come to a neurologic clinic in the past 6 months from the start date will be screened by searching for the ICD-10 code and diagnosis of sialorrhea and cross-referencing with those patients also being prescribed incobotulinumtoxinA. Data will be retrieved from the electronic medical record.
- Conditions
- Sialorrhea
- Keywords
- Sialorrhea
- Medical subject headings
- Sialorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed with Sialorrhea | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chart abstraction measured sialorrhea and its treatment in different neurological conditions
Chart abstraction measured sialorrhea and its treatment in different neurological conditions 11/1/2024 to 4/30/2025
Measured: 6 months
Secondary outcomes (5)
Correlation between the onset of sialorrhea and disease state
Correlation between the onset of sialorrhea and disease state from 11/01/2014-04/01/2025
Measured: 6 months
Dosage of incobotulinumtoxinA used per gland and overall, in the treatment of chronic sialorrhea.
Describe dosage of incobotulinumtoxinA used per gland and overall, in the treatment of chronic sialorrhea from 11/01/2024 to 04/01/2025
Measured: 6 months
Dose development of incobotulinumtoxinA over time
Describe dose development of incobotulinumtoxinA over time for Siallorhea
Measured: 6 months
Treatment pathway of sialorrhea
Describe treatment pathway of sialorrhea
Measured: 6 months
Patient population receiving incobotulinumtoxinA for sialorrhea treatment
Describe patient population receiving incobotulinumtoxinA for sialorrhea treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start10 Oct 2025
- Primary completion30 Mar 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SialorrheaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Merz Therapeutics GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881497
- Sponsor's protocol ID
- STUDY00009283
- Status last verified
- Sep 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jost WH, Friedman A, Michel O, Oehlwein C, Slawek J, Bogucki A, Ochudlo S, Banach M, Pagan F, Flatau-Baque B, Csikos J, Cairney CJ, Blitzer A. SIAXI: Placebo-controlled, randomized, double-blind study of incobotulinumtoxinA for sialorrhea. Neurology. 2019 Apr 23;92(17):e1982-e1991. doi: 10.1212/WNL.0000000000007368. Epub 2019 Mar 27.
PubMed 30918101Sanagustin D, Martin-Subero M, Hogg B, Fortea L, Gardoki I, Guinart D, Roldan M, Angelats M, Cerro L, Navas D, Jimenez JD, Ortiz L, Ros R, Polo X, Ventura Y, Contreras J, Moreno-Alcazar A, Perez-Sola V, Amann BL, Valiente-Gomez A. Prevalence of clozapine-induced sialorrhea and its effect on quality of life. Psychopharmacology (Berl). 2023 Jan;240(1):203-211. doi: 10.1007/s00213-022-06294-3. Epub 2022 Dec 20.
PubMed 36538098Morgante F, Bavikatte G, Anwar F, Mohamed B. The burden of sialorrhoea in chronic neurological conditions: current treatment options and the role of incobotulinumtoxinA (Xeomin(R)). Ther Adv Neurol Disord. 2019 Nov 28;12:1756286419888601. doi: 10.1177/1756286419888601. eCollection 2019.
PubMed 31819763
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Multicenter Chart Abstraction to Investigate the Prevalence of Chronic Sialorrhea, and the Real-world Use of incobotulinumtoxinA Injections in Male and Female Participants Aged 18 Years and Older With Chronic Sialorrhea
- ClinicalTrials.gov ID
- NCT07881497
- Acronym / sponsor ID
- STUDY00009283
- Conditions
- Sialorrhea
- Keywords
- Sialorrhea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Merz Therapeutics GmbH
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 19 Oct 2026 (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.
A retrospective, multicenter chart abstraction to investigate the prevalence of chronic sialorrhea, and the real-world use of incobotulinumtoxinA injections in male and female participants aged 18 years and older with chronic sialorrhea. Patients who come to a neurologic clinic in the past 6 months from the start date will be screened by searching for the ICD-10 code and diagnosis of sialorrhea and cross-referencing with those patients also being prescribed incobotulinumtoxinA. Data will be retrieved from the electronic medical record.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosed with Sialorrhea | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment occurs at MedStar Health-affiliated sites including: * Georgetown University Hospital, Washington, DC * Center for Neurodegenerative Diseases, McLean, VA * MedStar Montgomery Medical Center, Olney, MD * MedStar Washington Hospital Center, Washington, DC * MedStar Franklin Square Medical Center, Baltimore, MD
Key inclusion criteria (3 listed)
- Age 18 years and older
- Diagnosed with Sialorrhea
- Presence of comprehensive patient data
Key exclusion criteria (1 listed)
- Lack of data about Sialorrhea and its treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chart abstraction measured sialorrhea and its treatment in different neurological conditions
Time frame: 6 months
Chart abstraction measured sialorrhea and its treatment in different neurological conditions 11/1/2024 to 4/30/2025
5 secondary outcomes
Correlation between the onset of sialorrhea and disease state
Time frame: 6 months
Dosage of incobotulinumtoxinA used per gland and overall, in the treatment of chronic sialorrhea.
Time frame: 6 months
Dose development of incobotulinumtoxinA over time
Time frame: 6 months
Treatment pathway of sialorrhea
Time frame: 6 months
Patient population receiving incobotulinumtoxinA for sialorrhea treatment
Time frame: 6 months
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 19 Oct 2026.
- Background: PubMed 30918101Jost WH, Friedman A, Michel O, Oehlwein C, Slawek J, Bogucki A, Ochudlo S, Banach M, Pagan F, Flatau-Baque B, Csikos J, Cairney CJ, Blitzer A. SIAXI: Placebo-controlled, randomized, double-blind study of incobotulinumtoxinA for sialorrhea. Neurology. 2019 Apr 23;92(17):e1982-e1991. doi: 10.1212/WNL.0000000000007368. Epub 2019 Mar 27.
- Background: PubMed 36538098Sanagustin D, Martin-Subero M, Hogg B, Fortea L, Gardoki I, Guinart D, Roldan M, Angelats M, Cerro L, Navas D, Jimenez JD, Ortiz L, Ros R, Polo X, Ventura Y, Contreras J, Moreno-Alcazar A, Perez-Sola V, Amann BL, Valiente-Gomez A. Prevalence of clozapine-induced sialorrhea and its effect on quality of life. Psychopharmacology (Berl). 2023 Jan;240(1):203-211. doi: 10.1007/s00213-022-06294-3. Epub 2022 Dec 20.
- Background: PubMed 31819763Morgante F, Bavikatte G, Anwar F, Mohamed B. The burden of sialorrhoea in chronic neurological conditions: current treatment options and the role of incobotulinumtoxinA (Xeomin(R)). Ther Adv Neurol Disord. 2019 Nov 28;12:1756286419888601. doi: 10.1177/1756286419888601. eCollection 2019.
- 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.
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?
An observational study of Sialorrhea, run by Medstar Health Research Institute at 1 site in United States.
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 3 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 19 Oct 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 United States. 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?
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?
Chart abstraction measured sialorrhea and its treatment in different neurological conditions (time frame: 6 months). 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 NCT07881497, which also lists 3 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 19 Oct 2026.