Main Heading (Descriptor) TermsNCT06035913
Mid-and Long-term Efficacy of Ergot Alkaloids in the Treatment of Salivation in Patients With Parkinson's Disease.
An observational study of Main Heading (Descriptor) Terms, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
Parkinson's disease is the second most common neurodegenerative disease after Alzheimer's disease, the incidence of population over 60 years old in China is 1.37%, Parkinson's disease is often accompanied by various non-motor symptoms, such as salivation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Main Heading (Descriptor) Terms
- What is being tested?
- Dihydroergot mesylate
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 30 Jun 2024
- 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: Patients who meet the diagnostic criteria for Parkinson's disease and have varying degrees of salivation
Who may be able to join
- Age: Adult (≥ 18 years) Gender: male or female All patients met the British Parkinson's Association Brain Bank criteria for the clinical diagnosis of primary Parkinson's disease Patients had mild, moderate, to severe salivation (MDS-UPDRS-IL-2 score≥ 2) There has been no drug adjustment in the past 3 months Voluntarily sign an informed consent form
Who cannot join
- Secondary PD or Parkinson's superposition syndrome Those with severe cognitive impairment, speech impairment, dysarthria, and deafness who cannot cooperate with the completion of the examination History of previous drug allergy Have a condition other than Parkinson's disease that can cause severe salivation or other oral and glandular problems In the past 3 months, botulinum toxin, anticholinergic drugs, etc. have been used to treat salivation symptoms Severe cardiopulmonary diseases, tumors, liver and kidney diseases and other chronic wasting diseases People with mental disorders No previous history of dysphagia or salivation due to cerebral infarction or other causes Those who do not cooperate with the test requirements process and follow-up Those who had poor medication adherence during the study, including alcohol abuse and drug dependence Subjects enrolled in clinical trials of other drugs within 3 months Severe orthostatic hypotension and bradycardia and organic lesions of the heart, decreased renal function Subjects who the investigators consider unsuitable for clinical trials for other reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Doctor of Medicine, Chief Physician, Associate Professor, Master Supervisor, Administrative Deputy Director of Neurology.
Parkinson's disease is the second most common neurodegenerative disease after Alzheimer's disease, the incidence of population over 60 years old in China is 1.37%, Parkinson's disease is often accompanied by various non-motor symptoms, such as salivation. Salivation can occur at any time in Parkinson's disease, with an incidence of 32% to 74%, often leading to social embarrassment, skin infections, bad breath, aspiration pneumonia, etc. This not only reduces the quality of life of patients, but also increases the burden on caregivers. Salivation can improve symptoms with botulinum toxin injections, medications, and non-drug treatments. Dihydroergot mesylate has been shown to be effective in the treatment of salivation in patients with Parkinson's disease, and this study will further observe the medium- to long-term efficacy of the drug on salivation symptoms.
Read the detailed description
The objective of the study is to further observe the medium- and long-term efficacy and adverse reactions of the drug on the basis of the proven effectiveness of dihydroergot mesylate sustained-release tablets on salivation symptoms in patients with Parkinson's disease, and to evaluate the effect of the drug on swallowing function and cognitive function of patients and explore its possible mechanism of action. The study was based on a scale assessment of identified cases, and at the identified endpoints, the primary outcome was set as improvement in SCS-PD scale scores after March, and secondary outcomes were set as disease progression since March (as demonstrated by MDS-UPDRS Part III scale scores), changes in swallowing function, cognitive function, liver and kidney function indicators, and adverse effects.
- Conditions
- Main Heading (Descriptor) Terms
- Being tested
- Dihydroergot mesylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroergot mesylateDrug
take medicine
| Study group | Role | What they receive |
|---|---|---|
| Salivation group | The saliva group was instructed to take dihydroergot mesylate, one tablet twice a day, and observed the improvement of salivation after 1 week, after 1 month, after March and after 6 months. Receives: Drug: Dihydroergot mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of the SCS-PD scale
Improvement in salivation was assessed by the change in scores on the SCS-PD scale
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 posted13 Sep 2023
- Study start1 Sep 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 (1)Papers the sponsor has linked to this study.
- Other trials for Main Heading (Descriptor) TermsStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Youyong Tian, Study director, Chief physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035913
- Sponsor's protocol ID
- KY20230829-01
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jin H, Huang T, Wu J, Zhu Y, Gao Q, Tian Y. Mid-long term efficacy of dihydroergotoxine mesylate in treatment of sialorrhea in Parkinson's disease. Clin Neurol Neurosurg. 2026 Jan;260:109239. doi: 10.1016/j.clineuro.2025.109239. Epub 2025 Nov 11.
PubMed 41237588
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doctor of Medicine, Chief Physician, Associate Professor, Master Supervisor, Administrative Deputy Director of Neurology.
- ClinicalTrials.gov ID
- NCT06035913
- Acronym / sponsor ID
- KY20230829-01
- Conditions
- Main Heading (Descriptor) Terms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 13 Sep 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.
Parkinson's disease is the second most common neurodegenerative disease after Alzheimer's disease, the incidence of population over 60 years old in China is 1.37%, Parkinson's disease is often accompanied by various non-motor symptoms, such as salivation. Salivation can occur at any time in Parkinson's disease, with an incidence of 32% to 74%, often leading to social embarrassment, skin infections, bad breath, aspiration pneumonia, etc. This not only reduces the quality of life of patients, but also increases the burden on caregivers. Salivation can improve symptoms with botulinum toxin injections, medications, and non-drug treatments. Dihydroergot mesylate has been shown to be effective in the treatment of salivation in patients with Parkinson's disease, and this study will further observe the medium- to long-term efficacy of the drug on salivation symptoms.
Detailed description
The objective of the study is to further observe the medium- and long-term efficacy and adverse reactions of the drug on the basis of the proven effectiveness of dihydroergot mesylate sustained-release tablets on salivation symptoms in patients with Parkinson's disease, and to evaluate the effect of the drug on swallowing function and cognitive function of patients and explore its possible mechanism of action. The study was based on a scale assessment of identified cases, and at the identified endpoints, the primary outcome was set as improvement in SCS-PD scale scores after March, and secondary outcomes were set as disease progression since March (as demonstrated by MDS-UPDRS Part III scale scores), changes in swallowing function, cognitive function, liver and kidney function indicators, and adverse effects.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Salivation group | – | Drug: Dihydroergot mesylateThe saliva group was instructed to take dihydroergot mesylate, one tablet twice a day, and observed the improvement of salivation after 1 week, after 1 month, after March and after 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet the diagnostic criteria for Parkinson's disease and have varying degrees of salivation
Key inclusion criteria (1 listed)
- Age: Adult (≥ 18 years) Gender: male or female All patients met the British Parkinson's Association Brain Bank criteria for the clinical diagnosis of primary Parkinson's disease Patients had mild, moderate, to severe salivation (MDS-UPDRS-IL-2 score≥ 2) There has been no drug adjustment in the past 3 months Voluntarily sign an informed consent form
Key exclusion criteria (1 listed)
- Secondary PD or Parkinson's superposition syndrome Those with severe cognitive impairment, speech impairment, dysarthria, and deafness who cannot cooperate with the completion of the examination History of previous drug allergy Have a condition other than Parkinson's disease that can cause severe salivation or other oral and glandular problems In the past 3 months, botulinum toxin, anticholinergic drugs, etc. have been used to treat salivation symptoms Severe cardiopulmonary diseases, tumors, liver and kidney diseases and other chronic wasting diseases People with mental disorders No previous history of dysphagia or salivation due to cerebral infarction or other causes Those who do not cooperate with the test requirements process and follow-up Those who had poor medication adherence during the study, including alcohol abuse and drug dependence Subjects enrolled in clinical trials of other drugs within 3 months Severe orthostatic hypotension and bradycardia and organic lesions of the heart, decreased renal function Subjects who the investigators consider unsuitable for clinical trials for other reasons
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 |
|---|---|---|
| Dihydroergot mesylatetake medicine | Drug | Salivation group |
Primary outcome
Improvement of the SCS-PD scale
Time frame: 6 months
Improvement in salivation was assessed by the change in scores on the SCS-PD scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 41237588Jin H, Huang T, Wu J, Zhu Y, Gao Q, Tian Y. Mid-long term efficacy of dihydroergotoxine mesylate in treatment of sialorrhea in Parkinson's disease. Clin Neurol Neurosurg. 2026 Jan;260:109239. doi: 10.1016/j.clineuro.2025.109239. Epub 2025 Nov 11.
- 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.
Youyong Tian study director
Chief physician
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 Main Heading (Descriptor) Terms, run by Nanjing First Hospital, Nanjing Medical University 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 1 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. 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?
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?
Improvement of the SCS-PD scale (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 NCT06035913, which also lists 1 linked publication.
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 13 Sep 2023.