Efficacy and Safety Study of MYOBLOC® in the Treatment of Sialorrhea in Adult Subjects

Phase 3CompletedNCT01994109

Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC187 enrolled

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.

Primary Objective: To determine the efficacy of MYOBLOC (administered via intraglandular as a single total dose of 2,500 Units or 3,500 Units) versus placebo in the treatment of troublesome sialorrhea in adult subjects via the assessment of unstimulated salivary flow rate and clinical global impression of sialorrhea severity and improvement at Week 4 post-injection (Part A). It is hypothesized that both MYOBLOC doses will achieve greater efficacy than placebo in relieving sialorrhea at 4 weeks post-injection. To compare the safety and tolerability of MYOBLOC versus placebo over a 13 week post-injection period (Part A). Secondary Objective: To assess the onset and duration of therapeutic response of MYOBLOC using efficacy assessments performed at Weeks 1, 2, 4, 8, and 13 after the first treatment (Part A). To assess the duration of therapeutic response of MYOBLOC (administered via intraglandular as a single total dose of 3,500 Units) using efficacy assessments performed at intervals after treatments every 13 weeks over a maximum possible duration of 65 weeks (Part B). To determine the long-term safety and tolerability of MYOBLOC treatments every 13 weeks over a maximum possible duration of 65 weeks (Part B).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

187

Conditions

Sialorrhea

Interventions

MYOBLOCDRUG

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.

PLACEBOOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (34)

Unnamed facility

Loma Linda, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 4 Weeks

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.

Time frame: 4 weeks

Data from ClinicalTrials.gov

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