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 Purpose:

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

Disease:

Amyotrophic Lateral Sclerosis (ALS), Other

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Completed

Phase:

Phase III

Study Chair(s)/Principal Investigator(s):

Robert Chinnapongse, MD

Study Director: Cynthia A Rask, MD US WorldMeds

Clinicaltrials.gov ID (11 digit #):

NCT01994109

Neals Affiliated?

No

Coordinating Center Contact Information


Nikki Hutchins / .(JavaScript must be enabled to view this email address) / 502-815-8122
.(JavaScript must be enabled to view this email address) United States

Full Study 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.

Study Sponsor:

US WorldMeds LLC

Participant Duration:

Estimated Enrollment:

180

Estimated Study Start Date:

10/31/2013

Estimated Study Completion Date:

06/30/2015

Posting Last Modified Date:

05/31/2015

Date Study Added to alsconsortium.org:

12/10/2013
  • More Information

    Primary Outcome Measures:
    Unstimulated Salivary Flow Rate [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

    Secondary Outcome Measures:
    Clinical Global Impression Change (CGI-C) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Other Outcome Measures:
    Number of Subjects with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

    Adverse events and adverse events of special interest will be assessed at each study visit. Adverse events may be assessed by subject report, review of symptoms, vital signs, laboratory values, physical examination, neurological examination, dental examination and the review of the Columbia Suicide Severity Rating Scale (C-SSRS).

    NOTE: There are 21 sites participating around the United States. As of 12/11/2013, not all sites are currently recruiting -- please see contact information below to learn more.

    FOR MORE: https://clinicalt...CT01994109&rank=1

  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    85

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?


    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.

  • Site Contact Information