A Clinical Study of Dihydroergotine Mesylate Extended-release Tablets for the Treatment of Drooling in Parkinson's Disease.
NCT ID: NCT06319118
Last Updated: 2024-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
120 participants
INTERVENTIONAL
2023-10-01
2024-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo Comparator: placebo
control group patients, 40 cases
Placebo
placebo + usual care, placebo 5 mg daily; 2.5mg 2 times daily, after breakfast and dinner.
Experimental: dihydroergotine mesylate sustained-release tablets
treatment group patients, 80 cases
dihydroergotine mesylate sustained-release tablets
Dihydroergotine mesylate extended-release tablets + conventional treatment, dihydroergotine mesylate sustained-release tablets 5mg daily; 2.5mg 2 times daily, after breakfast and dinner.
Interventions
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Placebo
placebo + usual care, placebo 5 mg daily; 2.5mg 2 times daily, after breakfast and dinner.
dihydroergotine mesylate sustained-release tablets
Dihydroergotine mesylate extended-release tablets + conventional treatment, dihydroergotine mesylate sustained-release tablets 5mg daily; 2.5mg 2 times daily, after breakfast and dinner.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Second Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Locations
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The Second Arilliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Other Identifiers
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JD-LK2023091-I01
Identifier Type: -
Identifier Source: org_study_id
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