A Clinical Study of Dihydroergotine Mesylate Extended-release Tablets for the Treatment of Drooling in Parkinson's Disease.

March 19, 2026 updated by: Second Affiliated Hospital of Soochow University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215004
        • The Second Arilliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Comparator: placebo
control group patients, 40 cases
Drug: Placebo
placebo + usual care, placebo 5 mg daily; 2.5mg 2 times daily, after breakfast and dinner.
Experimental: Experimental: dihydroergotine mesylate sustained-release tablets
treatment group patients, 80 cases
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
the objective weight of saliva in patients with Parkinson's disease changed from baseline at the 4th, 8th and 12th weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

February 1, 2026

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JD-LK2023091-I01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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