Efficacy and Safety Study of MYOBLOC® in the Treatment of Sialorrhea in Adult Subjects (MYSTICOL)

March 31, 2026 updated by: Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

187

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russia
      • Krasnoyarsk, Russia, 660037
    • Irkutsk Oblast
      • Irkutsk, Irkutsk Oblast, Russia, 664079
    • Leningradskaya Oblast'
      • Vsevolozhsk, Leningradskaya Oblast', Russia, 188643
    • Petrodvorets
      • Saint Petersburg, Petrodvorets, Russia, 198510
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49027
      • Ivano-Frankivsk, Ukraine, 76008
      • Kharkiv, Ukraine, 61068
      • Lviv, Ukraine, 79010
      • Rivne, Ukraine, 33010
      • Uzhhorod, Ukraine, 88018
  • United States
    • California
      • Loma Linda, California, United States, 92354
      • Los Angeles, California, United States, 90033
      • National City, California, United States, 91950
    • Colorado
      • Aurora, Colorado, United States, 80045
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
    • Florida
      • Boca Raton, Florida, United States, 33486
      • Port Charlotte, Florida, United States, 33980
    • Indiana
      • Carmel, Indiana, United States, 46032
    • Maryland
      • Baltimore, Maryland, United States, 21287
      • Elkridge, Maryland, United States, 21075
    • Michigan
      • Detroit, Michigan, United States, 48334
    • Missouri
      • St Louis, Missouri, United States, 63110
    • New Jersey
      • Edison, New Jersey, United States, 08818
    • New York
      • Albany, New York, United States, 12208
      • New York, New York, United States, 10003
    • Ohio
      • Cincinnati, Ohio, United States, 45219
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
    • South Carolina
      • Port Royal, South Carolina, United States, 29935
    • Tennessee
      • Cordova, Tennessee, United States, 38018
    • Texas
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78229
    • Utah
      • Salt Lake City, Utah, United States, 84132
    • Washington
      • Kirkland, Washington, United States, 98034
      • Tacoma, Washington, United States, 98409

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MYOBLOC 2500 U
Subjects will receive specified dose of MYOBLOC
Drug: MYOBLOC
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.
Other Names:
  • rimabotulinumtoxinB, botulinum toxin type B
Active Comparator: MYOBLOC 3500 U
Subjects will receive specified dose of MYOBLOC
Drug: MYOBLOC
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.
Other Names:
  • rimabotulinumtoxinB, botulinum toxin type B
Placebo Comparator: Placebo
Subjects will receive volume matched Placebo
Other: PLACEBO
Other Names:
  • volume-matched placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A)
Time Frame: 4 Weeks
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)
Time Frame: 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC

Investigators

  • Study Director: Jonathan Rubin, MD, Supernus Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

November 14, 2013

First Submitted That Met QC Criteria

November 20, 2013

First Posted (Estimated)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SN-SIAL-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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