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

Amyotrophic Lateral Sclerosis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00125203
Study type Interventional
Source The University of Texas Health Science Center at San Antonio
Contact
Status Completed
Phase Phase 2/Phase 3
Start date July 2003
Completion date August 2007
View Details
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