Sialorrhea Secondary to Parkinson's Disease Clinical Trial
Official title:
A Two-Phase, Double Blind, Placebo-Controlled, Randomized, Crossover Study of the Safety and Efficacy of Intra-Oral NH004 Films for the Short-Term Relief of Sialorrhea Symptoms in Parkinson's Disease Patients
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment