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

Sponsor

The University of Texas Health Science Center at San Antonio (Other)

Overall Status

Completed

CT.gov ID

NCT00125203

Collaborator

ALS Association (Other), University of Kansas (Other), Carolinas MDA Neuromuscular/ALS Center-Carolinas Medical System (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Amyotrophic Lateral Sclerosis Sialorrhea	Drug: Botulinum toxin type B (Myobloc) Procedure: Injection of salivary glands	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2003

Actual Study Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

Global impression of change by subject at eight weeks post injection []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center/Neurology, 1008 Wescoe	Kansas City	Kansas	United States	66160-7314
2	Carolinas MDA Neuromuscular/ALS Center; Carolinas Medical System; 1540 Garden Terrace	Charlotte	North Carolina	United States	28203

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio
ALS Association
University of Kansas
Carolinas MDA Neuromuscular/ALS Center-Carolinas Medical System

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