NCT00125203

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Amyotrophic Lateral Sclerosis
• Sialorrhea

Interventions

Type	Name	Description
DRUG	Botulinum toxin type B (Myobloc)
PROCEDURE	Injection of salivary glands

Timeline

• Start date: 2003-07-01
• Completion: 2007-08-01
• First posted: 2005-07-29
• Last updated: 2012-03-14

Locations

2 sites across 1 country: United States