Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS)

A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of Botulinum Toxin Type B (Myobloc) in Sialorrhea in Amyotrophic Lateral Sclerosis

The purpose of this study is to determine the safety and efficacy of Myobloc in ALS patients who are having excessive drooling.

The primary goal of the study is to determine if the patient perceives a benefit from the Myobloc in controlling excessive drooling.

Study Overview

Detailed Description

The secondary goals of this study are to:

  • determine the safety of bilateral injections of Myobloc into the parotid and submandibular glands as an effort to control sialorrhea;
  • determine by objective measures if the Myobloc injection decreases the saliva produced;
  • determine caregiver perceived benefit from Myobloc injection.

Study Type

Interventional

Enrollment

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kansas
      • Kansas City, Kansas, United States, 66160-7314
        • University of Kansas Medical Center/Neurology, 1008 Wescoe
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas MDA Neuromuscular/ALS Center; Carolinas Medical System; 1540 Garden Terrace

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of probable or definite ALS based on current World Federation of Neurology criteria
  • Between the ages of 21-85, inclusive
  • Sialorrhea refractory to treatment with at least two anticholinergic medications OR has been intolerant of anticholinergic medications due to side effects
  • Capable of giving informed consent
  • Must be able to attend all study visits

Exclusion Criteria:

  • Patient has any uncontrolled significant medical, psychiatric or neurological disease (other than ALS) over the past 30 days
  • History of ongoing substance abuse
  • History of non-compliance with treatment in other experimental protocols
  • Cannot provide informed consent or comply with evaluation procedures
  • Has received any form of botulinum toxin in the past for any indication
  • Women who are pregnant, lactating, or of child bearing potential not using an adequate form of birth control
  • Currently being treated with coumadin
  • Forced vital capacity (FVC) <40% of predicted unless the tidal volume is > 600cc, as patients with significant bulbar weakness may show a falsely low FVC due to bulbar muscle spasticity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Global impression of change by subject at eight weeks post injection

Secondary Outcome Measures

Outcome Measure
Patient's subjective assessment of benefit
Change in volume of saliva produced over five minutes (measured with funnel and tube)
ALS Functional Rating Scale (ALSFRS)
Caregiver's subjective assessment of benefit
Change in anticholinergic medication doses and number of times per day suction is used
SEQOL-DW
Duration of benefit
Assessment of treatment assignment (final visit only)
Global assessment of change by investigator

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Carlayne E Jackson, MD, The University of Texas Health Science Center at San Antonio
  • Principal Investigator: Charles B Simpson, MD, The University of Texas Health Science Center at San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion (ACTUAL)

August 1, 2007

Study Registration Dates

First Submitted

July 27, 2005

First Submitted That Met QC Criteria

July 27, 2005

First Posted (ESTIMATE)

July 29, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 14, 2012

Last Update Submitted That Met QC Criteria

March 13, 2012

Last Verified

March 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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