NCT00761137

Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: NeuroHealing Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sialorrhea Secondary to Parkinson's Disease

Interventions

Type	Name	Description
DRUG	0.3 mg tropicamide	0.3 mg tropicamide in intra-oral thin film
DRUG	1 mg tropicamide	1 mg tropicamide in intra-oral thin film
DRUG	3 mg tropicamide	3 mg tropicamide in intra-oral thin film
DRUG	0 mg tropicamide	0 mg tropicamide (placebo) in intra-oral thin film

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2008-09-29
• Last updated: 2015-10-12
• Results posted: 2015-10-12

Locations

1 site across 1 country: Argentina