Conditions: Sialorrhoea
Keywords: oxybutynin clonidine OC Oral Solution sialorrhoea Parkinson's disease
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether OC (oxybutynin and clonidine) oral solution is effective in reducing saliva secretion in patients suffering from Parkinson's Disease with excessive salivation.

Detailed description:
Sialorrhea is excessive flow of saliva associated with its unintentional loss from the mouth, commonly known as drooling. Sialorrhea may result from any combination of hypersecretion, problems swallowing or sensorimotor problems containing saliva in the mouth. It is commonly found in people with neurological dysfunction such as Parkinson's Disease, leading to social isolation and embarrassment. In general, treatment options are limited because of the underlying chronic disease. The objective of the proposed low-dose, new combination drug, OC Oral solution is to develop a new treatment option that can be used to titrate saliva secretion rates to a level that is low enough to prevent unintentional loss (i.e. drooling) but not so low as to cause an uncomfortably dry mouth.

Arms:
arm 1: Placebo arm 2: High dose oxybutynin and clonidine arm 3: Low dose oxybutynin and clonidine arm 4: Intermediate dose oxybutynin and clonidine

Interventions: intervention 1: oxybutynin and clonidine oral solution treatment A intervention 2: oxybutynin and clonidine oral solution treatment B intervention 3: oxybutynin and clonidine oral solution treatment C intervention 4: oxybutynin and clonidine oral solution treatment D
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: Placebo

Protocol document: