Clinical Trial: Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief 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.
Detailed Summary:
Sponsor: US WorldMeds LLC
Current Primary Outcome: Unstimulated Salivary Flow Rate [ Time Frame: 4 Weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Clinical Global Impression Change (CGI-C) [ Time Frame: 4 weeks ]
Original Secondary Outcome: Same as current
Information By: US WorldMeds LLC
Dates:
Date Received: November 14, 2013
Date Started: November 2013
Date Completion:
Last Updated: May 1, 2017
Last Verified: May 2017