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

Sialorrhea Clinical Trial

— MYSTICOL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994109
• Other study ID #: SN-SIAL-301
• Status: Completed
• Phase: Phase 3
• Start date: November 2013
• Est. completion date: January 2017

Study information

• Verified date: August 2019
• Source: Supernus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Sialorrhea

Intervention

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:
• PLACEBO

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Supernus Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Russian Federation,  Ukraine, 

References & Publications (2)

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A)	Change weight of expectorated saliva at a Week 4 post-injection visit.	4 Weeks
Primary	Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A)	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.	4 weeks