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

NCT00125203 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-03-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Botulinum toxin type B (Myobloc)

PROCEDURE

Injection of salivary glands

Sponsors & Collaborators

  • ALS Association

    collaborator OTHER
  • University of Kansas

    collaborator OTHER
  • Carolinas MDA Neuromuscular/ALS Center-Carolinas Medical System

    collaborator UNKNOWN
  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Carlayne E Jackson, MD · The University of Texas Health Science Center at San Antonio

  • Charles B Simpson, MD · The University of Texas Health Science Center at San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Completion
2007-08-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00125203 on ClinicalTrials.gov