We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01994109
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
US WorldMeds LLC

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.

Condition or disease Intervention/treatment Phase
Sialorrhea Drug: MYOBLOC Other: PLACEBO Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2013
Primary Completion Date : January 2016
Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: MYOBLOC Dose 1
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 Name: rimabotulinumtoxinB, botulinum toxin type B
Active Comparator: MYOBLOC Dose 2
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 Name: rimabotulinumtoxinB, botulinum toxin type B
Placebo Comparator: Placebo
Subjects will receive volume matched Placebo
Other: PLACEBO
Other Name: volume-matched placebo



Primary Outcome Measures :
  1. Unstimulated Salivary Flow Rate [ Time Frame: 4 Weeks ]

Secondary Outcome Measures :
  1. Clinical Global Impression Change (CGI-C) [ Time Frame: 4 weeks ]

Other Outcome Measures:
  1. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994109


  Show 34 Study Locations
Sponsors and Collaborators
US WorldMeds LLC
Investigators
Study Director: Cynthia A Rask, MD US WorldMeds

Publications:
Responsible Party: US WorldMeds LLC
ClinicalTrials.gov Identifier: NCT01994109     History of Changes
Other Study ID Numbers: SN-SIAL-301
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by US WorldMeds LLC:
Sialorrhea
Parkinson's disease
Amyotrophic lateral sclerosis (ALS)
stroke
neuroleptics

Additional relevant MeSH terms:
rimabotulinumtoxinB
Sialorrhea
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Anti-Dyskinesia Agents