Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects - Full Text View

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 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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Amyotrophic Lateral Sclerosis

U.S. FDA Resources

Further study details as provided by US WorldMeds LLC:

Primary Outcome Measures:

Unstimulated Salivary Flow Rate [ Time Frame: 4 Weeks ]

Secondary Outcome Measures:

Clinical Global Impression Change (CGI-C) [ Time Frame: 4 weeks ]

Other Outcome Measures:

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)


Enrollment:	157
Study Start Date:	November 2013
Study Completion Date:	January 2017
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)
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

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:

Chinnapongse R, Gullo K, Nemeth P, Zhang Y, Griggs L. Safety and efficacy of botulinum toxin type B for treatment of sialorrhea in Parkinson's disease: a prospective double-blind trial. Mov Disord. 2012 Feb;27(2):219-26. doi: 10.1002/mds.23929. Epub 2011 Sep 1.

Ondo WG, Hunter C, Moore W. A double-blind placebo-controlled trial of botulinum toxin B for sialorrhea in Parkinson's disease. Neurology. 2004 Jan 13;62(1):37-40.


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:	May 1, 2017

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 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 September 19, 2017

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