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

Completed

Phase 3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Subjects will receive volume matched Placebo
  • MYOBLOC Drug
    Other Names: rimabotulinumtoxinB; botulinum toxin type B
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: MYOBLOC Dose 1
    Description: Subjects will receive specified dose of MYOBLOC
    ARM 2: Kind: Experimental
    Label: MYOBLOC Dose 2
    Description: Subjects will receive specified dose of MYOBLOC

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Unstimulated Salivary Flow Rate 4 Weeks No
Secondary Clinical Global Impression Change (CGI-C) 4 weeks No

Sponsors