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A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients

NCT00515437 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-04-21

Study results available
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Summary

To determine safety, tolerability and preliminary efficacy of intraglandular injections of MYOBLOC for the treatment of sialorrhea in Parkinsons' Disease patients

Conditions

  • Drooling

Interventions

BIOLOGICAL

Botulinum Toxin Type B (Myobloc)

BIOLOGICAL

Matched placebo to Myobloc

Sponsors & Collaborators

  • Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC

    lead INDUSTRY

Principal Investigators

  • Jonathan Rubin, MD,MBA · Supernus Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-06-30
Completion
2008-09-30

Countries

  • United States

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 NCT00515437 on ClinicalTrials.gov