Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects (MYSTICOL)
Primary Purpose
Sialorrhea
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MYOBLOC
PLACEBO
Sponsored by
About this trial
This is an interventional treatment trial for Sialorrhea focused on measuring Sialorrhea, Parkinson's disease, Amyotrophic lateral sclerosis (ALS), stroke, neuroleptics
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
MYOBLOC 2500 U
MYOBLOC 3500 U
Placebo
Arm Description
Subjects will receive specified dose of MYOBLOC
Subjects will receive specified dose of MYOBLOC
Subjects will receive volume matched Placebo
Outcomes
Primary Outcome Measures
Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A)
Change weight of expectorated saliva at a Week 4 post-injection visit.
Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A)
CGI-C was assessed on a 7-point scale ranging from "very much improved" to "very much worse" with 1 assigned to "very much improved" and 7 assigned to "very much worse"; ranging from a minimum score of 1 and a maximum score of 7.
Secondary Outcome Measures
Full Information
NCT ID
NCT01994109
First Posted
November 14, 2013
Last Updated
July 9, 2021
Sponsor
Supernus Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01994109
Brief Title
Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects
Acronym
MYSTICOL
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 Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Supernus Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sialorrhea
Keywords
Sialorrhea, Parkinson's disease, Amyotrophic lateral sclerosis (ALS), stroke, neuroleptics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MYOBLOC 2500 U
Arm Type
Active Comparator
Arm Description
Subjects will receive specified dose of MYOBLOC
Arm Title
MYOBLOC 3500 U
Arm Type
Active Comparator
Arm Description
Subjects will receive specified dose of MYOBLOC
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive volume matched Placebo
Intervention Type
Drug
Intervention Name(s)
MYOBLOC
Other Intervention Name(s)
rimabotulinumtoxinB, botulinum toxin type B
Intervention Description
MYOBLOC (rimabotulinumtoxinB) Injection, or botulinum toxin type B, is the "B" serotype of botulinum toxin. It is the only commercially available "B" serotype, and also the only available botulinum toxin that does not require reconstitution for use.
Intervention Type
Other
Intervention Name(s)
PLACEBO
Other Intervention Name(s)
volume-matched placebo
Primary Outcome Measure Information:
Title
Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A)
Description
Change weight of expectorated saliva at a Week 4 post-injection visit.
Time Frame
4 Weeks
Title
Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A)
Description
CGI-C was assessed on a 7-point scale ranging from "very much improved" to "very much worse" with 1 assigned to "very much improved" and 7 assigned to "very much worse"; ranging from a minimum score of 1 and a maximum score of 7.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Najeebah Abdul-Musawir, MD,MBA
Organizational Affiliation
Supernus Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08818
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
City
Port Royal
State/Province
South Carolina
ZIP/Postal Code
29935
Country
United States
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98409
Country
United States
City
Irkutsk
State/Province
Irkutsk Region
ZIP/Postal Code
664079
Country
Russian Federation
City
Vsevolozhsk
State/Province
Leningrad Region
ZIP/Postal Code
188643
Country
Russian Federation
City
St.Petersburg
State/Province
Petrodvorets
ZIP/Postal Code
198510
Country
Russian Federation
City
Krasnoyarsk
ZIP/Postal Code
660037
Country
Russian Federation
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
City
Rivne
ZIP/Postal Code
33010
Country
Ukraine
City
Uzhgorod
ZIP/Postal Code
88018
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
21887710
Citation
Chinnapongse R, Gullo K, Nemeth P, Zhang Y, Griggs L. Safety and efficacy of botulinum toxin type B for treatment of sialorrhea in Parkinson's disease: a prospective double-blind trial. Mov Disord. 2012 Feb;27(2):219-26. doi: 10.1002/mds.23929. Epub 2011 Sep 1.
Results Reference
result
PubMed Identifier
14718694
Citation
Ondo WG, Hunter C, Moore W. A double-blind placebo-controlled trial of botulinum toxin B for sialorrhea in Parkinson's disease. Neurology. 2004 Jan 13;62(1):37-40. doi: 10.1212/01.wnl.0000101713.81253.4c.
Results Reference
result
PubMed Identifier
31930364
Citation
Isaacson SH, Ondo W, Jackson CE, Trosch RM, Molho E, Pagan F, Lew M, Dashtipour K, Clinch T, Espay AJ; MYSTICOL Study Group. Safety and Efficacy of RimabotulinumtoxinB for Treatment of Sialorrhea in Adults: A Randomized Clinical Trial. JAMA Neurol. 2020 Apr 1;77(4):461-469. doi: 10.1001/jamaneurol.2019.4565.
Results Reference
derived
Learn more about this trial
Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects
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