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 (NH004-2)

NCT00761137 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	NeuroHealing Pharmaceuticals Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	19
Start date	2008-03
Completion	2010-06

Conditions

• Sialorrhea Secondary to Parkinson's Disease

Interventions

• 0.3 mg tropicamide
• 1 mg tropicamide
• 3 mg tropicamide
• 0 mg tropicamide

Primary outcomes

• Sialorrhea Visual Analogue Scale (VAS) — Before and 120 min after treatment administration
  Saliva buccal assessment was evaluated by an VAS scale before, and 15, 30, 45, 60, 90, and 120 min after treatment administration. Subjects were asked to rate how much saliva they perceived in their buccal cavity on an unmarked 0 to 10 cm line, higher scores meaning greater perceived buccal saliva levels.

Countries

Argentina