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Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects (MYSTICOL)

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ClinicalTrials.gov Identifier: NCT01994109
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : August 15, 2019
Last Update Posted : July 13, 2021
Sponsor:
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE November 14, 2013
First Posted Date  ICMJE November 25, 2013
Results First Submitted Date  ICMJE May 2, 2019
Results First Posted Date  ICMJE August 15, 2019
Last Update Posted Date July 13, 2021
Study Start Date  ICMJE November 2013
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
Unstimulated Salivary Flow Rate [ Time Frame: 4 Weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
Clinical Global Impression Change (CGI-C) [ Time Frame: 4 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: November 20, 2013)
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4 weeks ]
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)
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sialorrhea
Intervention  ICMJE
  • 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 Name: rimabotulinumtoxinB, botulinum toxin type B
  • Other: PLACEBO
    Other Name: volume-matched placebo
Study Arms  ICMJE
  • Active Comparator: MYOBLOC 2500 U
    Subjects will receive specified dose of MYOBLOC
    Intervention: Drug: MYOBLOC
  • Active Comparator: MYOBLOC 3500 U
    Subjects will receive specified dose of MYOBLOC
    Intervention: Drug: MYOBLOC
  • Placebo Comparator: Placebo
    Subjects will receive volume matched Placebo
    Intervention: Other: PLACEBO
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2019)
187
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2013)
180
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01994109
Other Study ID Numbers  ICMJE SN-SIAL-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Supernus Pharmaceuticals, Inc.
Study Sponsor  ICMJE Supernus Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Najeebah Abdul-Musawir, MD,MBA Supernus Pharmaceuticals, Inc.
PRS Account Supernus Pharmaceuticals, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP