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
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
- Amyotrophic Lateral Sclerosis
- Sialorrhea
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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