Efficacy and Safety Study of MYOBLOC® in the Treatment of Sialorrhea in Adult Subjects
MYSTICOL
Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC® Followed by Open-Label, Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects
1 other identifier
interventional
187
3 countries
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2013
Typical duration for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 14, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedResults Posted
Study results publicly available
August 15, 2019
CompletedApril 21, 2026
March 1, 2026
2.2 years
November 14, 2013
May 2, 2019
March 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
4 Weeks
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.
4 weeks
Study Arms (3)
MYOBLOC 2500 U
ACTIVE COMPARATORSubjects will receive specified dose of MYOBLOC
MYOBLOC 3500 U
ACTIVE COMPARATORSubjects will receive specified dose of MYOBLOC
Placebo
PLACEBO COMPARATORSubjects will receive volume matched Placebo
Interventions
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.
Eligibility Criteria
You may qualify if:
- Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring secondary to any disorder or related to any cause
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Unknown Facility
Loma Linda, California, 92354, United States
Unknown Facility
Los Angeles, California, 90033, United States
Unknown Facility
National City, California, 91950, United States
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
Washington D.C., District of Columbia, 20007, United States
Unknown Facility
Boca Raton, Florida, 33486, United States
Unknown Facility
Port Charlotte, Florida, 33980, United States
Unknown Facility
Carmel, Indiana, 46032, United States
Unknown Facility
Baltimore, Maryland, 21287, United States
Unknown Facility
Elkridge, Maryland, 21075, United States
Unknown Facility
Detroit, Michigan, 48334, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Edison, New Jersey, 08818, United States
Unknown Facility
Albany, New York, 12208, United States
Unknown Facility
New York, New York, 10003, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Tulsa, Oklahoma, 74136, United States
Unknown Facility
Port Royal, South Carolina, 29935, United States
Unknown Facility
Cordova, Tennessee, 38018, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Salt Lake City, Utah, 84132, United States
Unknown Facility
Kirkland, Washington, 98034, United States
Unknown Facility
Tacoma, Washington, 98409, United States
Unknown Facility
Irkutsk, Irkutsk Oblast, 664079, Russia
Unknown Facility
Vsevolozhsk, Leningradskaya Oblast', 188643, Russia
Unknown Facility
Saint Petersburg, Petrodvorets, 198510, Russia
Unknown Facility
Krasnoyarsk, 660037, Russia
Unknown Facility
Dnipropetrovsk, 49027, Ukraine
Unknown Facility
Ivano-Frankivsk, 76008, Ukraine
Unknown Facility
Kharkiv, 61068, Ukraine
Unknown Facility
Lviv, 79010, Ukraine
Unknown Facility
Rivne, 33010, Ukraine
Unknown Facility
Uzhhorod, 88018, Ukraine
Related Publications (3)
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.
PMID: 21887710RESULTOndo 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.
PMID: 14718694RESULTIsaacson 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.
PMID: 31930364DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Regulatory Affairs Associate
- Organization
- Solstice Neurosciences
Study Officials
- STUDY DIRECTOR
Jonathan Rubin, MD
Supernus Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2013
First Posted
November 25, 2013
Study Start
November 1, 2013
Primary Completion
January 1, 2016
Study Completion
January 1, 2017
Last Updated
April 21, 2026
Results First Posted
August 15, 2019
Record last verified: 2026-03