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

Phase 3

Completed

• Conditions: Sialorrhea
• Interventions: Drug: MYOBLOC; Other: PLACEBO

• Registration Number: NCT01994109
• Lead Sponsor: Supernus Pharmaceuticals, Inc.

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 Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-14
• Study First Submitted QC: 2013-11-20
• Study First Posted: 2013-11-25
• Primary Completion: 2016-01
• Study Completion: 2017-01
• Disposition First Submitted: 2017-02-09
• Disposition First Submitted QC: 2017-02-09
• Disposition First Posted: 2017-02-10
• Results First Submitted: 2019-05-02
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-14
• Results First Posted: 2019-08-15
• Last Update Submitted: 2021-07-09
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MYOBLOC 2500 U	MYOBLOC	Subjects will receive specified dose of MYOBLOC
MYOBLOC 3500 U	MYOBLOC	Subjects will receive specified dose of MYOBLOC
Placebo	PLACEBO	Subjects will receive volume matched Placebo

Primary Outcome Measures

Name	Time	Method
Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A)	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)	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.