Drooling treatment study pulled before it began
NCT ID NCT07070817
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study planned to test whether injecting botulinum toxin (Botox) into the salivary glands could reduce drooling in people with true bulbar palsy, a condition that causes swallowing problems after a brain stem injury. The trial was designed to compare the injections against standard swallowing therapy alone. However, the study was withdrawn before any participants were enrolled, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Botulinum toxin type A (Botox) injected into salivary glands
- What this could lead to
- If it had worked, this could have pointed toward a treatment to reduce drooling in people with true bulbar palsy.
- What could go wrong
- The study was withdrawn before enrolling anyone, so no results are available. Botulinum toxin injections can cause temporary weakness or swallowing difficulties.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Expected to start
-
Dec 2025
An estimate. Start dates often move.
- Expected to finish
-
Sep 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Sialorrhea true bulbar palsy medullary injury are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Fuxing Hospital Affiliated to Capital Medical University
Beijing, China