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
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