Mid-and Long-term Efficacy of Ergot Alkaloids in the Treatment of Salivation in Patients With Par… (NCT06035913) | Clinical Trial Compass
UnknownNot Applicable
Mid-and Long-term Efficacy of Ergot Alkaloids in the Treatment of Salivation in Patients With Parkinson's Disease.
China80 participantsStarted 2023-09-01
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
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 o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses ergot alkaloids to treat excessive saliva production in Parkinson's disease — can you explain what ergot alkaloids are and whether their known side effects, like potential effects on heart valves, would be a concern for my specific situation?
2The trial's recruitment status is listed as unknown, so before we look into it further, do you know if this study is still actively enrolling patients or whether it has been paused or completed?
3The trial measures improvement using something called the SCS-PD scale — can you explain what that scale measures and whether it captures the saliva-related symptoms that bother me most day-to-day?
4Since this is listed without a specific phase, does that mean there may be less safety and effectiveness data available compared to a standard phased drug trial, and how would that affect your recommendation about whether to consider it?
5Are there any standard treatments already available for saliva control in Parkinson's disease — such as certain medications or botulinum toxin injections — that you think I should try first before exploring a trial like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement of the SCS-PD scale
Timeframe: 6 months
Trial details
NCT IDNCT06035913
SponsorNanjing First Hospital, Nanjing Medical University