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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2016

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: MYOBLOC 2500 U
    • Subjects will receive specified dose of MYOBLOC
  • Active Comparator: MYOBLOC 3500 U
    • Subjects will receive specified dose of MYOBLOC
  • Placebo Comparator: Placebo
    • Subjects will receive volume matched Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A)
    • Time Frame: 4 Weeks
    • Change weight of expectorated saliva at a Week 4 post-injection visit.
  • Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A)
    • Time Frame: 4 weeks
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Supernus Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Najeebah Abdul-Musawir, MD,MBA, Study Director, Supernus Pharmaceuticals, Inc.

Citations Reporting on Results

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. doi: 10.1212/01.wnl.0000101713.81253.4c.

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