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

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.

Inclusion criteria

• Diagnosis of probable or definite ALS based on current World Federation of Neurology criteria
• Between the ages of 21-85, inclusive
• Sialorrhea refractory to treatment with at least two anticholinergic medications OR has been intolerant of anticholinergic medications due to side effects
• Capable of giving informed consent
• Must be able to attend all study visits

Exclusion criteria

• Patient has any uncontrolled significant medical, psychiatric or neurological disease (other than ALS) over the past 30 days
• History of ongoing substance abuse
• History of non-compliance with treatment in other experimental protocols
• Cannot provide informed consent or comply with evaluation procedures
• Has received any form of botulinum toxin in the past for any indication
• Women who are pregnant, lactating, or of child bearing potential not using an adequate form of birth control
• Currently being treated with coumadin
• Forced vital capacity (FVC) <40% of predicted unless the tidal volume is > 600cc, as patients with significant bulbar weakness may show a falsely low FVC due to bulbar muscle spasticity