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: July 22, 2016
Last verified: July 2016
  Purpose
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 Intervention Phase
Sialorrhea
Drug: MYOBLOC
Other: PLACEBO
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by US WorldMeds LLC:

Primary Outcome Measures:
  • Unstimulated Salivary Flow Rate [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression Change (CGI-C) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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)


Estimated Enrollment: 180
Study Start Date: November 2013
Estimated Study Completion Date: December 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994109

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

Publications:
Responsible Party: US WorldMeds LLC
ClinicalTrials.gov Identifier: NCT01994109     History of Changes
Other Study ID Numbers: SN-SIAL-301 
Study First Received: November 14, 2013
Last Updated: July 22, 2016
Health Authority: United States: Food and Drug Administration
Ukraine: Ministry of Health
Russia: Ministry of Health of the Russian Federation

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

Additional relevant MeSH terms:
Sialorrhea
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Botulinum Toxins
Botulinum Toxins, Type A
AbobotulinumtoxinA
OnabotulinumtoxinA
IncobotulinumtoxinA
RimabotulinumtoxinB
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

ClinicalTrials.gov processed this record on August 28, 2016