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Efficacy and Safety Study of MYOBLOC� Followed by Open-Label Multiple-Treatment With MYOBLOC� in the Treatment of Troublesome Sialorrhea in Adult Subjects

Information source: US WorldMeds LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sialorrhea

Intervention: MYOBLOC (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: US WorldMeds LLC

Official(s) and/or principal investigator(s):
Cynthia A Rask, MD, Study Director, Affiliation: US WorldMeds

Overall contact:
Nikki Hutchins, Phone: 502-815-8122, Email: nhutchins@usworldmeds.com

Summary

This study will evaluate the efficacy and safety of MYOBLOC in the treatment of Sialorrhea (drooling), which can be a symptom of many disease conditions. MYOBLOC will be injected directly into the salivary glands. MYOBLOC has been shown in previous trials to safely decrease saliva production, thereby demonstrating its potential as a safe and effective treatment for troublesome sialorrhea.

Clinical Details

Official title: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC® (Part A) Followed by Open-Label, Multiple-Treatment With MYOBLOC® (Part B) in the Treatment of Troublesome Sialorrhea in Adult Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Unstimulated Salivary Flow Rate

Secondary outcome: Clinical Global Impression Change (CGI-C)

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring

secondary to any disorder or related to any cause

- Investigator sites will review entire list of inclusion criteria with potential

subjects Exclusion Criteria:

- Any known prior exposure to botulinum toxin type B, or known adverse reaction or

sensitivity to botulinum toxin type A, or known sensitivity to any of the MYOBLOC solution components.

- Prior botulinum toxin treatment to the salivary glands at any time

- Investigator sites will review entire list of exclusion criteria with potential

subjects

Locations and Contacts

Nikki Hutchins, Phone: 502-815-8122, Email: nhutchins@usworldmeds.com

Dnipropetrovsk 49027, Ukraine; Recruiting

Ivano-Frankivsk 76008, Ukraine; Recruiting

Kharkiv 61068, Ukraine; Not yet recruiting

Lviv 79010, Ukraine; Recruiting

Odesa 65025, Ukraine; Recruiting

Rivne 33010, Ukraine; Recruiting

Uzhgorod 88018, Ukraine; Recruiting

Loma Linda, California 92354, United States; Recruiting

Los Angeles, California 90033, United States; Recruiting

National City, California 91950, United States; Recruiting

Aurora, Colorado 80045, United States; Recruiting

Washington, District of Columbia 20007, United States; Recruiting

Boca Raton, Florida 33486, United States; Recruiting

Port Charlotte, Florida 33980, United States; Recruiting

Carmel, Indiana 46032, United States; Recruiting

Baltimore, Maryland 21287, United States; Recruiting

Elkridge, Maryland 21075, United States; Recruiting

Detroit, Michigan 48334, United States; Recruiting

West Bloomfield, Michigan 48322, United States; Withdrawn

St Louis, Missouri 63110, United States; Recruiting

Edison, New Jersey 08818, United States; Recruiting

Albany, New York 12208, United States; Recruiting

New York City, New York 10003, United States; Recruiting

Cincinnati, Ohio 45219, United States; Recruiting

Cleveland, Ohio 44195, United States; Withdrawn

Tulsa, Oklahoma 74136, United States; Recruiting

Port Royal, South Carolina 29935, United States; Recruiting

Cordova, Tennessee 38018, United States; Recruiting

Bedford, Texas 76021, United States; Withdrawn

Houston, Texas 77030, United States; Recruiting

San Antonio, Texas 78229, United States; Recruiting

Salt Lake City, Utah 84132, United States; Recruiting

Kirkland, Washington 98034, United States; Recruiting

Tacoma, Washington 98409, United States; Recruiting

Additional Information

Starting date: November 2013
Last updated: August 21, 2015

Page last updated: August 23, 2015

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