SialorrheaPhase 3MYSTICOLNCT01994109
Efficacy and Safety Study of MYOBLOC® in the Treatment of Sialorrhea in Adult Subjects
A Phase 3 study testing MYOBLOC in people with Sialorrhea, run by Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC at 34 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sialorrhea
- What is being tested?
- MYOBLOC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 34 sitesin 3 countries
- Study dates
- Nov 2013to Jan 2017
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
34 sites in 3 countries.
34 sites in 3 countries
United States24 sites
Study site
Albany, New York, 12208
Study site
Aurora, Colorado, 80045
Study site
Baltimore, Maryland, 21287
Study site
Boca Raton, Florida, 33486
Study site
Carmel, Indiana, 46032
Study site
Cincinnati, Ohio, 45219
Study site
Cordova, Tennessee, 38018
Study site
Detroit, Michigan, 48334
Study site
Edison, New Jersey, 08818
Study site
Elkridge, Maryland, 21075
Study site
Houston, Texas, 77030
Study site
Kirkland, Washington, 98034
Study site
Loma Linda, California, 92354
Study site
Los Angeles, California, 90033
Study site
National City, California, 91950
Study site
New York, New York, 10003
Study site
Port Charlotte, Florida, 33980
Study site
Port Royal, South Carolina, 29935
Study site
Salt Lake City, Utah, 84132
Study site
San Antonio, Texas, 78229
Study site
St Louis, Missouri, 63110
Study site
Tacoma, Washington, 98409
Study site
Tulsa, Oklahoma, 74136
Study site
Washington D.C., District of Columbia, 20007
Ukraine6 sites
Study site
Dnipropetrovsk, 49027
Study site
Ivano-Frankivsk, 76008
Study site
Kharkiv, 61068
Study site
Lviv, 79010
Study site
Rivne, 33010
Study site
Uzhhorod, 88018
Russia4 sites
Study site
Irkutsk, Irkutsk Oblast, 664079
Study site
Krasnoyarsk, 660037
Study site
Saint Petersburg, Petrodvorets, 198510
Study site
Vsevolozhsk, Leningradskaya Oblast', 188643
About this study
Official title: 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
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.
Read the detailed description
Primary Objective: To determine the efficacy of MYOBLOC (administered via intraglandular as a single total dose of 2,500 Units or 3,500 Units) versus placebo in the treatment of troublesome sialorrhea in adult subjects via the assessment of unstimulated salivary flow rate and clinical global impression of sialorrhea severity and improvement at Week 4 post-injection (Part A). It is hypothesized that both MYOBLOC doses will achieve greater efficacy than placebo in relieving sialorrhea at 4 weeks post-injection.
To compare the safety and tolerability of MYOBLOC versus placebo over a 13 week post-injection period (Part A).
Secondary Objective: To assess the onset and duration of therapeutic response of MYOBLOC using efficacy assessments performed at Weeks 1, 2, 4, 8, and 13 after the first treatment (Part A).
To assess the duration of therapeutic response of MYOBLOC (administered via intraglandular as a single total dose of 3,500 Units) using efficacy assessments performed at intervals after treatments every 13 weeks over a maximum possible duration of 65 weeks (Part B).
To determine the long-term safety and tolerability of MYOBLOC treatments every 13 weeks over a maximum possible duration of 65 weeks (Part B).
- Conditions
- Sialorrhea
- Being tested
- MYOBLOC, PLACEBO
- Keywords
- Sialorrhea, Parkinson's disease, Amyotrophic lateral sclerosis (ALS), stroke, neuroleptics
- Medical subject headings
- Sialorrhea, Parkinson Disease, Amyotrophic Lateral Sclerosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MYOBLOCDrug
Also called rimabotulinumtoxinB, botulinum toxin type B
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.
PLACEBOOther
Also called volume-matched placebo
| Study group | Role | What they receive |
|---|---|---|
| MYOBLOC 2500 U | Active comparator | Subjects will receive specified dose of MYOBLOC Receives: Drug: MYOBLOC |
| MYOBLOC 3500 U | Active comparator | Subjects will receive specified dose of MYOBLOC Receives: Drug: MYOBLOC |
| Placebo | Placebo comparator | Subjects will receive volume matched Placebo Receives: Other: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SialorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Rubin, MD, Study director, Supernus Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994109
- Sponsor's protocol ID
- SN-SIAL-301
- Acronym
- MYSTICOL
- Status last verified
- Mar 2026
- First submitted
- 14 Nov 2013
- Last updated
- 21 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21887710Ondo 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.
PubMed 14718694Isaacson 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.
PubMed 31930364