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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
University of Kansas Medical Center/Neurology, 1008 Wescoe
Kansas City, Kansas, United States
Carolinas MDA Neuromuscular/ALS Center; Carolinas Medical System; 1540 Garden Terrace
Charlotte, North Carolina, United States
Global impression of change by subject at eight weeks post injection
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
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