Trials / Completed
CompletedNCT06319118
A Clinical Study of Dihydroergotine Mesylate Extended-release Tablets for the Treatment of Drooling in Parkinson's Disease.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Second Affiliated Hospital of Soochow University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | placebo + usual care, placebo 5 mg daily; 2.5mg 2 times daily, after breakfast and dinner. |
| 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. |
Timeline
- Start date
- 2023-10-01
- Primary completion
- 2025-09-30
- Completion
- 2026-02-01
- First posted
- 2024-03-19
- Last updated
- 2026-03-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06319118. Inclusion in this directory is not an endorsement.