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

NCT00761137 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2015-10-12

Study results available
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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.

Conditions

  • Sialorrhea Secondary to Parkinson's Disease

Interventions

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

Sponsors & Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

    collaborator OTHER

  • NeuroHealing Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Elkan R Gamzu, PhD · NeuroHealing Pharmaceuticals Inc.

  • Marcelo Merello, MD, PhD · FLENI Hospital, Argentina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00761137 on ClinicalTrials.gov