Study Purpose:
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.Study Status:
Not recruiting
Disease:
Sialorrhea
Study Type:
Interventional
Type of Intervention:
Drug, N/A
Intervention Name:
MYOBLOC, PLACEBO
Placebo:
Phase:
Phase 3
Study Chair(s)/Principal Investigator(s):
Najeebah Abdul-Musawir, MD,MBA, Supernus Pharmaceuticals, Inc.
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
United States
Full Study 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.
Study Sponsor:
Supernus Pharmaceuticals, Inc.
Estimated Enrollment:
187
Estimated Study Start Date:
10 / 31 / 2013
Estimated Study Completion Date:
01 / 01 / 2017
Posting Last Modified Date:
07 / 13 / 2021
Date Study Added to neals.org:
11 / 25 / 2013
Primary Outcome Measures:
Unstimulated Salivary Flow Rate [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Clinical Global Impression Change (CGI-C) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Other Outcome Measures:
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Adverse events and adverse events of special interest will be assessed at each study visit. Adverse events may be assessed by subject report, review of symptoms, vital signs, laboratory values, physical examination, neurological examination, dental examination and the review of the Columbia Suicide Severity Rating Scale (C-SSRS).
NOTE: There are 21 sites participating around the United States. As of 12/11/2013, not all sites are currently recruiting -- please see contact information below to learn more.
FOR MORE: https://clinicalt...CT01994109&rank=1
Minimum Age:
18 Years
Maximum Age:
85 Years
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
Loma Linda, California
92354
United States
Los Angeles, California
90033
United States
National City, California
91950
United States
Aurora, Colorado
80045
United States
Washington, District of Columbia
20007
United States
Boca Raton, Florida
33486
United States
Port Charlotte, Florida
33980
United States
Carmel, Indiana
46032
United States
Baltimore, Maryland
21287
United States
Elkridge, Maryland
21075
United States
Detroit, Michigan
48334
United States
Saint Louis, Missouri
63110
United States
Edison, New Jersey
08818
United States
Albany, New York
12208
United States
New York, New York
10003
United States
Cincinnati, Ohio
45219
United States
Tulsa, Oklahoma
74136
United States
Port Royal, South Carolina
29935
United States
Cordova, Tennessee
38018
United States
Houston, Texas
77030
United States
San Antonio, Texas
78229
United States
Salt Lake City, Utah
84132
United States
Kirkland, Washington
98034
United States
Tacoma, Washington
98409
United States
Irkutsk, Irkutsk Region
664079
Russian Federation
Vsevolozhsk, Leningrad Region
188643
Russian Federation
St.Petersburg, Petrodvorets
198510
Russian Federation
Krasnoyarsk 660037
Russian Federation
Dnipropetrovsk 49027
Ukraine
Ivano-Frankivsk 76008
Ukraine
Kharkiv 61068
Ukraine
Lviv 79010
Ukraine
Rivne 33010
Ukraine
Uzhgorod 88018
Ukraine