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New hope for Parkinson's drooling: drug trial shows promise

NCT ID NCT06319118

Symptom relief Sponsor: Second Affiliated Hospital of Soochow University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether dihydroergotine mesylate extended-release tablets can reduce drooling in people with Parkinson's disease. 120 patients took either the drug or a placebo for 12 weeks. Researchers measured changes in saliva weight and also looked at effects on thinking skills.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dihydroergotine mesylate extended-release tablets
What this could lead to
If it works, this could provide a new option to reduce drooling and possibly improve cognitive function in people with Parkinson's disease.
What could go wrong
This is a small, completed phase 4 trial with only 120 participants. The results may not apply to all Parkinson's patients, and the drug may cause side effects or fail to show a meaningful benefit over placebo.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

120 people

The number who actually took part.

Started

Oct 2023

Finished

Feb 2026

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 years and older

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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 2. drooling score using the Parkinson\'s Comprehensive Rating Scale (UPDRS) Part II (Item 6) ≥3; 3. MMSE ≥ 10 points (recording the patient\'s education level) 4. Adults over the age of 18 5. The applicant or his/her caregiver must be able to complete the record of the salivation score 6. Patients or family members voluntarily participate and sign an informed consent form. Exclusion Criteria: 1. Patients with non-primary Parkinson\'s disease 2. Known allergy to dihydroergotamine mesylate 3. 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 4. BoNT treatment for saliva within the previous 3 months 5. 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

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Salivation in Parkinson's disease

Contacts and locations

Locations

  • The Second Arilliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.