Conditions: Sialorrhea Secondary to Parkinson's Disease
Keywords: sialorrhea drooling excessive salivation parkinson's disease
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 19
Healthy volunteers: no

Brief summary:
The primary goal of the study is to evaluate the safety and potential efficacy of intra-oral dissolvable NH004 films to improve the short-term symptoms of sialorrhea (drooling) in Parkinson's disease (PD) patients.

Detailed description:
NH004 contains the anticholinergic agent tropicamide and is delivered in a convenient product form (intra-oral dissolvable thin films) designed for the management of sialorrhea. This study is a double blind, placebo-controlled, crossover study of the safety and potential efficacy of three doses of of NH004 films for the short-term relief of the symptoms of sialorrhea in Parkinson's disease patients.

A total of up to 36 Parkinson's disease patients will be enrolled in the study in two Phases. Phase A will include 12 patients and Phase B up to 24 patients. There will be an interim analysis after conclusion of Phase A. In both phases patients will be randomized into one of four groups. Each group will have a distinctive sequence for receiving intra-oral dissolvable films of 0.3 mg, 1 mg, 3 mg of NH004, or placebo during four visits.

Arms:
arm 1: subject received (blinded) each of the 4 drug doses at different visits - 0 mg tropicamide, 0.3 mg tropicamide, 1 mg tropicamide, 3 mg tropicamide arm 2: subject received (blinded) each of the 4 drug doses at different visits - 0.3 mg tropicamide, 1 mg tropicamide, 3 mg tropicamide, 0 mg tropicamide arm 3: subject received (blinded) each of the 4 drug doses at different visits - 1 mg tropicamide, 3 mg tropicamide, 0 mg tropicamide, 0.3 mg tropicamide arm 4: subject received (blinded) each of the 4 drug doses at different visits - 3 mg tropicamide, 0 mg tropicamide, 0.3 mg tropicamide, 1 mg tropicamide

Interventions: intervention 1: 0.3 mg tropicamide intervention 2: 1 mg tropicamide intervention 3: 3 mg tropicamide intervention 4: 0 mg tropicamide
Intervention descriptions: intervention 1: 0.3 mg tropicamide in intra-oral thin film intervention 2: 1 mg tropicamide in intra-oral thin film intervention 3: 3 mg tropicamide in intra-oral thin film intervention 4: 0 mg tropicamide (placebo) in intra-oral thin film

Protocol document: