Salivation in Parkinson's DiseasePhase 4NCT06319118
A Clinical Study of Dihydroergotine Mesylate Extended-release Tablets for the Treatment of Drooling in Parkinson's Disease.
A Phase 4 study testing dihydroergotine mesylate sustained-release tablets in people with Salivation in Parkinson's Disease, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Objective: To evaluate the efficacy and safety of dihydroergotine mesylate extended-release tablets for salivation in Parkinson\'s disease Study content: Using a randomized, double-blind, placebo-controlled study design, 120 patients with Parkinson\'s disease and cognitive impairment were enrolled, and the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Salivation in Parkinson's Disease
- What is being tested?
- dihydroergotine mesylate sustained-release tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 1 Feb 2026
- Phase
- Phase 4
- 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
Who may be able to join
- Patients with Parkinson\'s disease diagnosed by the British Parkinson\'s Disease Brain Bank Diagnostic Criteria can come to the hospital accompanied by family members
- drooling score using the Parkinson\'s Comprehensive Rating Scale (UPDRS) Part II (Item 6) ≥3;
- MMSE ≥ 10 points (recording the patient\'s education level)
- Adults over the age of 18
- The applicant or his/her caregiver must be able to complete the record of the salivation score
- Patients or family members voluntarily participate and sign an informed consent form.
Who cannot join
- Patients with non-primary Parkinson\'s disease
- Known allergy to dihydroergotamine mesylate
- Drug-induced hypersalivation, such as olanzapine, antipsychotics, clonazepam and other antiepileptic drugs, as well as direct and indirect cholinergic agonists for the treatment of Alzheimer\'s disease and myasthenia gravis
- BoNT treatment for saliva within the previous 3 months
- Patients with symptomatic bradycardia, severe orthostatic hypotension, symptomatic coronary insufficiency, severe organic cardiac damage, severe liver and kidney insufficiency: including ALT≥2.5ULN (upper limit of normal value of the executive laboratory); AST≥2.5ULN (upper limit of normal for the execution laboratory); Creatinine ≥ 1.5 ULN (upper limit of normal at the execution laboratory), active psychosis, pregnancy/pregnant woman
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Arilliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
About this study
Objective: To evaluate the efficacy and safety of dihydroergotine mesylate extended-release tablets for salivation in Parkinson\'s disease Study content: Using a randomized, double-blind, placebo-controlled study design, 120 patients with Parkinson\'s disease and cognitive impairment were enrolled, and the treatment was followed up for 12 weeks: dihydroergotine mesylate sustained-release tablets + conventional treatment (treatment group patients, 80 cases), placebo + conventional treatment (control group patients, 40 cases), and the main indicators were observed: the improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was observed, and the secondary indicators were observed: the effect of dihydroergotine mesylate sustained-release tablets on the cognitive function of PD patients was observed.
Expected results: The improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was significantly different from that of the placebo control group. The dihydroergotine mesylate sustained-release tablet group had a significant effect on the cognitive function of PD patients.
- Conditions
- Salivation in Parkinson's Disease
- Being tested
- Placebo, dihydroergotine mesylate sustained-release tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
placebo + usual care, placebo 5 mg daily; 2.5mg 2 times daily, after breakfast and dinner.
dihydroergotine mesylate sustained-release tabletsDrug
Dihydroergotine mesylate extended-release tablets + conventional treatment, dihydroergotine mesylate sustained-release tablets 5mg daily; 2.5mg 2 times daily, after breakfast and dinner.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator: placebo | Placebo comparator | control group patients, 40 cases Receives: Drug: Placebo |
| Experimental: dihydroergotine mesylate sustained-release tablets | Experimental | treatment group patients, 80 cases Receives: Drug: dihydroergotine mesylate sustained-release tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
the objective weight of saliva in patients with Parkinson's disease changed from baseline
Measured: the objective weight of saliva in patients with Parkinson's disease changed from baseline at the 4th, 8th and 12th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Oct 2023
- Primary completion30 Sep 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivation in Parkinson's DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319118
- Sponsor's protocol ID
- JD-LK2023091-I01
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2024
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Dihydroergotine Mesylate Extended-release Tablets for the Treatment of Drooling in Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT06319118
- Acronym / sponsor ID
- JD-LK2023091-I01
- Conditions
- Salivation in Parkinson's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 19 Mar 2024 (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.
Objective: To evaluate the efficacy and safety of dihydroergotine mesylate extended-release tablets for salivation in Parkinson\'s disease Study content: Using a randomized, double-blind, placebo-controlled study design, 120 patients with Parkinson\'s disease and cognitive impairment were enrolled, and the treatment was followed up for 12 weeks: dihydroergotine mesylate sustained-release tablets + conventional treatment (treatment group patients, 80 cases), placebo + conventional treatment (control group patients, 40 cases), and the main indicators were observed: the improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was observed, and the secondary indicators were observed: the effect of dihydroergotine mesylate sustained-release tablets on the cognitive function of PD patients was observed.
Expected results: The improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was significantly different from that of the placebo control group. The dihydroergotine mesylate sustained-release tablet group had a significant effect on the cognitive function of PD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator: placebo | Placebo comparator | Drug: Placebocontrol group patients, 40 cases |
| Experimental: dihydroergotine mesylate sustained-release tablets | Experimental | Drug: dihydroergotine mesylate sustained-release tabletstreatment group patients, 80 cases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with Parkinson\'s disease diagnosed by the British Parkinson\'s Disease Brain Bank Diagnostic Criteria can come to the hospital accompanied by family members
- drooling score using the Parkinson\'s Comprehensive Rating Scale (UPDRS) Part II (Item 6) ≥3;
- MMSE ≥ 10 points (recording the patient\'s education level)
- Adults over the age of 18
- The applicant or his/her caregiver must be able to complete the record of the salivation score
Key exclusion criteria (5 listed)
- Patients with non-primary Parkinson\'s disease
- Known allergy to dihydroergotamine mesylate
- Drug-induced hypersalivation, such as olanzapine, antipsychotics, clonazepam and other antiepileptic drugs, as well as direct and indirect cholinergic agonists for the treatment of Alzheimer\'s disease and myasthenia gravis
- BoNT treatment for saliva within the previous 3 months
- Patients with symptomatic bradycardia, severe orthostatic hypotension, symptomatic coronary insufficiency, severe organic cardiac damage, severe liver and kidney insufficiency: including ALT≥2.5ULN (upper limit of normal value of the executive laboratory); AST≥2.5ULN (upper limit of normal for the execution laboratory); Creatinine ≥ 1.5 ULN (upper limit of normal at the execution laboratory), active psychosis, pregnancy/pregnant woman
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 |
|---|---|---|
| Placeboplacebo + usual care, placebo 5 mg daily; 2.5mg 2 times daily, after breakfast and dinner. | Drug | Placebo Comparator: placebo |
| dihydroergotine mesylate sustained-release tabletsDihydroergotine mesylate extended-release tablets + conventional treatment, dihydroergotine mesylate sustained-release tablets 5mg daily; 2.5mg 2 times daily, after breakfast and dinner. | Drug | Experimental: dihydroergotine mesylate sustained-release tablets |
Primary outcome
the objective weight of saliva in patients with Parkinson's disease changed from baseline
Time frame: the objective weight of saliva in patients with Parkinson's disease changed from baseline at the 4th, 8th and 12th weeks
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 23 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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?
A Phase 4 study testing dihydroergotine mesylate sustained-release tablets in people with Salivation in Parkinson's Disease, run by Second Affiliated Hospital of Soochow 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 6 inclusion and 5 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 23 Mar 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
the objective weight of saliva in patients with Parkinson's disease changed from baseline (time frame: the objective weight of saliva in patients with Parkinson's disease changed from baseline at the 4th, 8th and 12th weeks). 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 23 Mar 2026.