Efficacy of Sublingual Administration of Atropine Solution for Drooling in Patient with Parkinson’s Disease: A randomized, double-blind, placebo-controlled, crossover study

Phase 3

• Conditions: Drooling in Patient with Parkinson’s Disease; s disease patients; Drooling, Atropine solution, Parkinson&#39

• Registration Number: TCTR20180320005
• Lead Sponsor: one

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-20
• Study Completion: 2020-09-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Inclusion criteria included patients diagnosed with Parkinson’s disease(PD) according to United Kingdom Parkinson’s Disease Society Brain Bank (UKPDS-BB) criteria by neurologists, age more than 17 years, suffering from drooling which was evaluated by Movement Disorders Society - United Parkinson’s Disease Rating Scale (MDS-UPDRS) part II: item 2.2; salivation and drooling subscore more than 1 score. The patients have not been received 1% atropine solution before, had the stable regimen of PD medications or stable Deep Brain Stimulation(DBS) setting in case of having the device for the preceding 2 weeks, and no changes were to be made to other antiparkinsonian medication doses or DBS setting during this study

Exclusion Criteria

Exclusion criteria for the trial included the patients who had drooling from other causes such as dental problem, active hallucinations or psychosis, cardiovascular disease and, or cardiac arrhythmia, history of Botulinum toxin injection to salivary gland, active treatment with an anticholinergic drug. The patients getting pregnant or lactating women, diagnosed with Parkinson’s disease with dementia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of sublingual administration of atropine solution for drooling in PD patients 1 week Movement Disorders Society - United Parkinson’s Disease Rating Scale (MDS-UPDRS) part II: item 2.2

Secondary Outcome Measures

Name	Time	Method
Objective measurement of volume of saliva 1 week weight of saliva in dental roll,Severity of drooling 1 week Drooling Severity and Frequency Scale (DSFS) ,Quality of life 1 week Visual analogue scale ,Adverse events 1 week History taking and questionnaire of adverse events