NCT06035913

Mid-and Long-term Efficacy of Ergot Alkaloids in the Treatment of Salivation in Patients With Parkinson's Disease.

Doctor of Medicine, Chief Physician, Associate Professor, Master Supervisor, Administrative Deputy Director of Neurology.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objective of the study is to further observe the medium- and long-term efficacy and adverse reactions of the drug on the basis of the proven effectiveness of dihydroergot mesylate sustained-release tablets on salivation symptoms in patients with Parkinson's disease, and to evaluate the effect of the drug on swallowing function and cognitive function of patients and explore its possible mechanism of action. The study was based on a scale assessment of identified cases, and at the identified endpoints, the primary outcome was set as improvement in SCS-PD scale scores after March, and secondary outcomes were set as disease progression since March (as demonstrated by MDS-UPDRS Part III scale scores), changes in swallowing function, cognitive function, liver and kidney function indicators, and adverse effects.

Conditions

• Main Heading (Descriptor) Terms

Interventions

Type	Name	Description
DRUG	Dihydroergot mesylate	take medicine

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2023-09-13
• Last updated: 2023-09-13

Locations

1 site across 1 country: China