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Study of the Safety and Efficacy of Tropicamide Thin Films to Reduce Hypersalivation in Parkinson's Patients

NCT01844648 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-12-10

No results posted yet for this study

Summary

To study the safety and efficacy of tropicamide 1 mg intra-oral slow dissolving muco-adhesive thin films compared to placebo to reduce hypersalivation in PD patients manifesting sialorrhea complaints.

Conditions

  • Sialorrhea (Excessive Drooling)

Interventions

DRUG

NH004 tropicamide

Intra-oral slow dissolving muco-adhesive thin film containing 1 mg tropicamide

DRUG

NH004 Placebo

Intra-oral slow dissolving muco-adhesive 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.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-10-31
Completion
2015-12-31

Countries

  • France

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 NCT01844648 on ClinicalTrials.gov