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CompletedNCT07881497Updated Oct 19, 2026

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 in Sialorrhea, sponsored by Medstar Health Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Medstar Health Research Institute · Observational

Updated Oct 19, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
206
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Sialorrhea

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Keywords

  • Sialorrhea
03

In context

Sialorrhea

57 studies on the registry are indexed under Sialorrhea; 6 are open to participants now.

This study's enrollment of 206 is above the median of 90 across 11 observational studies indexed under Sialorrhea.

Browse Sialorrhea studies →

Lead sponsor

Medstar Health Research Institute is the lead sponsor of 161 studies on the registry; 32 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 years and older
  • Diagnosed with Sialorrhea
  • Presence of comprehensive patient data

Exclusion criteria

Exclusion Criteria:

  • Lack of data about Sialorrhea and its treatment
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
206 participants (actual)
Patient registry
No

Groups and cohorts

  • Diagnosed with Sialorrhea
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What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

Secondary outcomes

  1. 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

    Time frame: 6 months

  2. 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

    Time frame: 6 months

  3. Dose development of incobotulinumtoxinA over time

    Describe dose development of incobotulinumtoxinA over time for Siallorhea

    Time frame: 6 months

  4. Treatment pathway of sialorrhea

    Describe treatment pathway of sialorrhea

    Time frame: 6 months

  5. Patient population receiving incobotulinumtoxinA for sialorrhea treatment

    Describe patient population receiving incobotulinumtoxinA for sialorrhea treatment

    Time frame: 6 months

07

Study locations

1 site
  • MedStar Montgomery Medical Center
    Olney, Maryland 20832, United States
08

References and documents

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 30918101 ↗
  • Sanagustin 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 36538098 ↗
  • Morgante 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 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2025 to primary completion in Mar 2026, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2026
First posted
Oct 19, 2026
StartActual
Oct 10, 2025
Primary completionActual
Mar 30, 2026
CompletionActual
Aug 30, 2026
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07881497
Responsible party
Sponsor
First posted
Oct 19, 2026
Start date
Oct 10, 2025
Primary completion
Mar 30, 2026
Completion
Aug 30, 2026
Last update
Oct 19, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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