Clinical trial NCT06319118: A Clinical Study of Dihydroergotine Mesylate Extended-release Tablets for the Treatment of Drooling in Parkinson's Disease.
Official title: A Clinical Study of Dihydroergotine Mesylate Extended-release Tablets for the Treatment of Drooling in Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Salivation in Parkinson's Disease
Lead sponsor: Second Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To evaluate the efficacy and safety of dihydroergotine mesylate extended-release tablets for salivation in Parkinson\&#39;s disease Study content: Using a randomized, double-blind, placebo-controlled study design, 120 patients with Parkinson\&#39;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.


Eligibility criteria: Inclusion Criteria:

1. Patients with Parkinson\&#39;s disease diagnosed by the British Parkinson\&#39;s Disease Brain Bank Diagnostic Criteria can come to the hospital accompanied by family members
2. drooling score using the Parkinson\&#39;s Comprehensive Rating Scale (UPDRS) Part II (Item 6) ≥3;
3. MMSE ≥ 10 points (recording the patient\&#39;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\&#39;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\&#39;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

Primary outcomes:
measure: the objective weight of saliva in patients with Parkinson's disease changed from baseline
timeFrame: the objective weight of saliva in patients with Parkinson's disease changed from baseline at the 4th, 8th and 12th weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The Second Arilliated Hospital of Soochow University
state: Jiangsu
Study officials:
References: