CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
0.3 mg tropicamide +3 moredrug
Likely dose
0.3 mg tropicamidefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00761137
NCT00761137Phase 2Completed
CompareCT.gov

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

NeuroHealing Pharmaceuticals Inc.·interventional·Posted Sep 29, 2008·Updated Oct 12, 2015

In Brief

A Phase 2 clinical trial evaluating 0.3 mg tropicamide, 1 mg tropicamide, and 2 other interventions for Sialorrhea Secondary to Parkinson's Disease. Completed, enrolled 19 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSialorrhea Secondary to Parkinson's Disease
CountriesArgentina
CollaboratorsMichael J. Fox Foundation for Parkinson's Research

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 29, 2008
Enrollment StartMar 1, 2008
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.8 years ago

Interventions

0.3 mg tropicamidedrug

0.3 mg tropicamide in intra-oral thin film

1 mg tropicamidedrug

1 mg tropicamide in intra-oral thin film

3 mg tropicamidedrug

3 mg tropicamide in intra-oral thin film

0 mg tropicamidedrug

0 mg tropicamide (placebo) in intra-oral thin film