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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
US WorldMeds LLC
ClinicalTrials.gov Identifier:
NCT01994109
First received: November 14, 2013
Last updated: February 1, 2016
Last verified: February 2016

November 14, 2013
February 1, 2016
November 2013
January 2016   (final data collection date for primary outcome measure)
Unstimulated Salivary Flow Rate [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01994109 on ClinicalTrials.gov Archive Site
Clinical Global Impression Change (CGI-C) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
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)
Same as current
 
Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Sialorrhea
  • 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
  • Active Comparator: MYOBLOC Dose 1
    Subjects will receive specified dose of MYOBLOC
    Intervention: Drug: MYOBLOC
  • Active Comparator: MYOBLOC Dose 2
    Subjects will receive specified dose of MYOBLOC
    Intervention: Drug: MYOBLOC
  • Placebo Comparator: Placebo
    Subjects will receive volume matched Placebo
    Intervention: Other: PLACEBO

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
180
December 2016
January 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Russian Federation,   Ukraine
 
NCT01994109
SN-SIAL-301
No
Not Provided
Not Provided
US WorldMeds LLC
US WorldMeds LLC
Not Provided
Study Director: Cynthia A Rask, MD US WorldMeds
US WorldMeds LLC
February 2016

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